People are lucky if they go to one great hospital for AIDS treatment. Others go to thirty-four.

Trials Open to Enrollment

Categories of Trials

The ACTG conducts offers a wide range of studies for people infected with HIV. Clinical trials that are currently Open to Enrollment are listed by Category on the following pages.

Select from the Categories (click on the buttons above) that best describe the type of trial you are interested in.

For each trial in the category, a link to more detailed information about the study will be provided on the next page:

  • DESCRIPTION of study and Full TITLE
  • STATUS of study (Open to enrollment or Pending)
  • WHY is the study being done? (Objectives)
  • WHO is eligible? (Eligibility criteria)
  • HOW does the study work? (Study design/ regimens)
  • WHAT do subjects receive? (Study drugs)
  • PARTICIPATING SITES (For Location and Contact information, go to the ACTU Locator map.)

Treatment Naive

Studies in this section are for people who are Treatment Naive, which means that they have never taken HIV medications before. These studies are designed to help find out what treatments work best as an initial regimen.

A5208: Optimal Combined Therapy After Nevirapine Exposure

Enrolling

This is a study comprising two trials. Both trials will compare the virologic response to NNRTI-based versus protease inhibitor (PI)-based anti-HIV therapy in 640 HIV-infected women who have only received single dose nevirapine (NVP) as MTCT (mother to child transmission) prevention (Trial 1) or who have never been on anti-HIV therapy (Trial 2). This international study will be conducted in resource-limited settings.
Why
- Trial 1 (participants with prior single dose NVP prophylaxis) will compare the time to virologic failure or death between participants initiating anti-HIV therapy with a regimen including NVP versus a regimen including Lopinavir/ritonavir (LPV/RTV).

- Trial 2 (participants with no prior NVP exposure) will compare the time to virologic failure or death between participants initiating anti-HIV therapy with a regimen including NVP versus a regimen including LPV/RTV.

- To evaluate the difference in the effect of NVP-based and PI (LPV/RTV)-based anti-HIV therapy on the time to virologic failure or death in participants with prior NVP prophylaxis (Trial 1) versus no prior NVP exposure (Trial 2).
Who
- Women who are HIV positive

- Age 13 years or older, or have attained the minimum age of consent

- CD4 cell count <200

- Trial 1: Last single dose of nevirapine for MTCT prevention must have occurred at least 6 months ago (up to 10 weeks of previous AZT alone allowed) OR Trail 2: Never taken any anti-HIV medications.

- Willing to not get pregnant during the time of study participation.

- Not breast feeding

- Receipt of tuberculosis treatment within 30 days of study entry
How
Women in each Trial will be randomly assigned to either:

Arm 1A: Tenofovir, Emtricitabine, and Nevirapine

Arm 1B: Tenofovir, Emtricitabine, and Lopinavir/ritonavir

The study will last for 48 weeks after the last person enrolls.
What
Tenofovir, entricitabine (FTC), and nevirapine or lopinavir/ritonavir (Kaletra) will be provided by the study.
Participating Sites (find contact information)
  • University of Witwatersrand, Johannesburg
  • University of KwaZulu-Natal, Durban
  • Chris Hani Baragwaneth Hospital, Johannesburg
  • Joint Clinical Research Centre, Kampala
  • Walter Reed Project, Kericho
  • MOI University Faculty of Health Sciences, Eldoret
  • Botswana Harvard School of Public Health AIDS Init
  • Centre for Infectious Disease Research in Zambia
  • Lilongwe Central Hospital Campus, Lilongwe
  • University of Zimbabwe, Harare
  • Joint Clinical Research Centre, Kampala
  • Lilongwe Central Hospital Campus, Lilongwe
  • Centre for Infectious Disease Research in Zambia
  • Botswana Harvard School of Public Health AIDS Init
  • Botswana Harvard-SPHAI Partnership Scottish Living
A5217: TDF+FTC+LPV/r vs. no ART in New Infections

Enrolling

This is a 2-step 96 week study of the effects anti-HIV therapy administered during early but not acute HIV-1 infection. Participants will be randomized to tenofovir, FTC and Kaletra for 36 weeks vs. no treatment.
Why
To determine if potent anti-HIV therapy vs. no therapy in newly infected patients changes the level of HIV virus when the therapy is discontinued.
Who
- Early HIV-1 infection acquired within the past 6 months, but beyond acute infection (positive HIV antibody test at screening, but negative test within 6 months)

- CD4 cell count greater than 350

- HIV viral load greater than 500 copies/ml

- Must be willing to stop treatment after 36 weeks if assigned to the treatment group
How
An equal number of participants will be randomized (assigned by chance) to either no anti-HIV treatment for 96 weeks OR treatment with tenofovir, emtricitabine (FTC) and Kaletra for 36 weeks followed by no treatment to 96 weeks. If the participant's CD4 count drops, viral load increases or clinical disease progresses while off treatment, therapy can be started.
What
tenofovir, emtricitabine (FTC), Kaletra is provided by the study.
Participating Sites (find contact information)
  • UCLA Care Center
  • Northwestern University
  • Rush-Presbyterian/St.Lukes
  • University of Miami
  • Harvard (Massachusetts General Hospital)
  • Indiana University Hospital
  • Wishard Memorial
  • University of Washington
  • University of Pennsylvania
  • Presbyterian Medical Center
  • University of Washington Primary Infection Clinic
  • Washington University (St. Louis)
  • The Miriam Hospital
  • Rhode Island Hospital
  • Stanley Street Treatment and Resource (SSTAR)
  • University of Rochester Medical Center
  • Community Health Network, Inc.
  • Duke University Medical Center
  • The Ohio State University
  • SUNY-Buffalo
  • Beth Israel Medical Center
  • Emory University
  • University of North Carolina
  • Moses H. Cone Hospital-IMPT
  • Wake County Human Services
  • Bellevue Hospital (NYU)
A5221-: Immediate vs. Deferred ART in Subjects with TB and CD4<200

Enrolling

This is a study to see whether people infected with HIV who are being treated for tuberculosis (TB) should start taking anti-HIV drugs earlier or later compared to when they start their anti-TB drugs.
Why
To compare between people who start anti-HIV drugs as soon as they enter the study and people who start their anti-HIV drugs later the number of people surviving without getting a new AIDS-defining illness.
Who
- HIV-infected males or females at least 13 years old
- CD4 cell count less than 200 (a CD4 cell count is a measure of how well your body can fight infections).
- No more than 7 days total of any anti-HIV drugs (unless it was during pregnancy)
- Recently started TB treatment with rifampin (RIF) or other similar drug
- Cannot have shown resistance to 2 or more anti-TB drugs

NOTE: People who are very ill with advanced AIDS, including those who are hospitalized, are also eligible
How
Participants will receive TB treatment according to World Health Organization (WHO) treatment guidelines and their country's national treatment guidelines.

Participants will be assigned by chance (as if by the flip of a coin) to:
Start anti-HIV drugs within 3 days

OR

Postpone starting anti-HIV drugs until 8-12 weeks after starting anti-TB drugs.

No matter when anti-HIV drugs are started, participants will take these drugs:

- Efavirenz (EFV) (Sustiva or Stocrin) once a day by mouth PLUS
- Emtricitabine (FTC)/Tenofovir (TDF) (Truvada) once a day by mouth

The study will last 48 weeks for each subject.
What
Anti-TB drugs will not be supplied by the study.

EFV will be provided by the study to international sites in the very near future. For now, sites that have access to an approved source of EFV may use that instead. Sites in the U.S. will have to provide EFV themselves.

FTC/TDF(Truvada) will be provided by the study.
Participating Sites (find contact information)
  • Oswaldo Cruz Foundation, Rio de Janeiro
  • Asociacion Civil IMPACTA Salud y Education, Lince
  • Lilongwe Central Hospital Campus, Lilongwe
  • YRG Centre for AIDS Research and Education, Chennai
  • Hospital Nossa Senhora da Conceicao, Porto Alegre
  • University of Witwatersrand, Johannesburg
  • University of KwaZulu-Natal, Durban
  • Bellevue Hospital (NYU)
  • University of California, San Diego
  • San Francisco General Hospital
  • University of Southern California
  • Harbor/ UCLA
  • The Miriam Hospital
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Treatment Experienced

The following studies are for people who are Treatment Experienced, meaning that they are currently on medications or have taken medications in the past for HIV. Each study has a unique approach: Which are the best medications to treat with? When is the best time to change medications? How do we know when to change medications?

A5001: ACTG Longitudinal Linked Randomized Trials (ALLRT) Protocol

Enrolling

Adult AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT) Protocol
Why
To determine treatment strategies that are effective in achieving long-term suppression of HIV with the fewest side effects.

To determine the long-term rates and types of HIV-related disease that occur during anti-HIV therapy.

To determine factors associated with the immune system's response to treatment.
Who
Patients participating in other AACTG treatment strategy trials currently or in the past.
How
Clinical and laboratory evaluations every 16 weeks.
What
Observational study (at least 5 years)
Participating Sites (find contact information)
  • Wake County Human Services
  • Hennepin County Medical Center
  • Presbyterian Medical Center
  • University of Maryland, Institute of Human Virology
  • UCD ACTU at the CARES Clinic
  • University of California
  • Georgetown University Medical Center
  • Rhode Island Hospital
  • Stanley Street Treatment and Resource (SSTAR)
  • The Miriam Hospital
  • Columbia Presbyterian Center of New York Presbyterian Hospital
  • The University of Texas Southwestern Medical Center at Dallas
  • University of Southern California
  • Community Health Network, Inc.
  • Vanderbilt University School of Medicine
  • Comprehensive Care Center
  • Santa Clara Valley Medical Center
  • University of Pennsylvania
  • Cornell Clinical Trials Unit
  • Cornell Clinical Trials Unit- Chelsea
  • Rush-Presbyterian/St.Lukes
  • Boston Medical Center
  • Brigham and Women's Hospital
  • St. Mary's Hospital
  • SUNY-Buffalo
  • University of Alabama at Birmingham
  • Johns Hopkins University
  • University of Colorado Health Science Center
  • University of Puerto Rico
  • University of California, San Diego
  • UCLA Care Center
  • Moses H. Cone Hospital-IMPT
  • University of Pittsburgh
  • Wishard Memorial
  • Indiana University Hospital
  • University of Iowa Hospitals and Clinic
  • Cook County Bureau of Health Services
  • Harbor/ UCLA
  • Beth Israel Deaconess Medical Center
  • Duke University Medical Center
  • Beth Israel Medical Center
  • University of Rochester Medical Center
  • University of Washington
  • Emory University
  • University of Minnesota
  • University of North Carolina
  • University of Cincinnati
  • Bellevue Hospital (NYU)
  • Stanford University Medical School
  • San Mateo County AIDS Program
  • Willow Clinic
  • Northwestern University
  • The Ohio State University
  • Washington University (St. Louis)
  • Hawaii ACTU
  • Marin County Department of Health
  • San Francisco General Hospital
  • University of Nebraska
  • University of Miami
  • Case Western/University Hospitals of Cleveland
  • University of Texas, Galveston
  • MetroHealth Medical Center
  • Harvard (Massachusetts General Hospital)
A5128: Consent for Stored Human Biological Materials For Currently Unspecified Analysis

Enrolling

Informed consent to use stored specimens for currently unspecified/ genetic analyses.
Why
To develop a standard operating procedure to establish a storage bank for specimens for future genetic (DNA) analyses.
Who
Anyone enrolled in an AACTG study.
How
Blood specimen collected at one time point only.
What
Blood stored for future testing.
Participating Sites (find contact information)
  • Hennepin County Medical Center
  • University of Washington Primary Infection Clinic
  • Dallas VA Medical Center
  • Wake County Human Services
  • University of Maryland, Institute of Human Virology
  • UCD ACTU at the CARES Clinic
  • University of Puerto Rico
  • Emory University
  • Georgetown University Medical Center
  • Harbor/ UCLA
  • University of California
  • University of Southern California
  • Wishard Memorial
  • Marin County Department of Health
  • The University of Texas Southwestern Medical Center at Dallas
  • Brigham and Women's Hospital
  • University of Minnesota
  • Boston Medical Center
  • University of California, San Diego
  • Columbia Presbyterian Center of New York Presbyterian Hospital
  • Beth Israel Deaconess Medical Center
  • Northwestern University
  • Johns Hopkins University
  • Moses H. Cone Hospital-IMPT
  • University of North Carolina
  • San Francisco General Hospital
  • The Ohio State University
  • University of Iowa Hospitals and Clinic
  • Cornell Clinical Trials Unit
  • Cornell Clinical Trials Unit- Chelsea
  • University of Texas, Galveston
  • Santa Clara Valley Medical Center
  • SUNY-Buffalo
  • Indiana University Hospital
  • University of Pennsylvania
  • Presbyterian Medical Center
  • UCLA Care Center
  • Harvard (Massachusetts General Hospital)
  • Vanderbilt University School of Medicine
  • University of Washington
  • St. Mary's Hospital
  • Bellevue Hospital (NYU)
  • The Miriam Hospital
  • Rhode Island Hospital
  • Stanley Street Treatment and Resource (SSTAR)
  • MetroHealth Medical Center
  • University of Nebraska
  • Cook County Bureau of Health Services
  • University of Pittsburgh
  • University of Colorado Health Science Center
  • University of Cincinnati
  • University of Miami
  • Duke University Medical Center
  • Stanford University Medical School
  • San Mateo County AIDS Program
  • Willow Clinic
  • University of Rochester Medical Center
  • Community Health Network, Inc.
  • Washington University (St. Louis)
  • Hawaii ACTU
  • Beth Israel Medical Center
  • Rush-Presbyterian/St.Lukes
  • University of Alabama at Birmingham
  • Case Western/University Hospitals of Cleveland
  • Comprehensive Care Center
A5176-: Tolerability, Safety, Immunogenicity of LC002 (DermaVir vaccine) in HIV Subjects

Enrolling - Re-Opened

This study will see if the DermaVir vaccine (LC002) is safe and tolerable in people infected with HIV who are currently under treatment with highly active anti-HIV therapy (HAART). DermaVir is given as a patch on the skin. It has not been approved by the Food and Drug Administration for use in treating HIV infection in humans.
Why
This study is being done to find out whether DermaVir is safe in humans and what the best dose is for treating HIV infection. The safety of DermaVir is currently being studied in persons with HIV in another study in Europe.
Who
- Viral load less than 50 copies/mL and not greater than 500 in the past 24 weeks.

- CD4 cell count currently greater than 350. Lowest CD4 count at any time must have been above 250.

- On a stable anti-HIV regimen (containing drugs from at least 2 different classes) without changes or interruptions (for more than 4 consecutive days) for at least 12 weeks.

- Men or women ages 18 - 50 years.

- No history of diabetes, active skin diseases, and chronic autoimmune or bleeding disorders.

- No excessive sun exposure (natural sun or tanning beds) within 2 weeks.

- No treatment with steroid creams on the back and thighs within 2 weeks.
How
Depending on when you enter the study, you will be registered to one of the three groups noted below. You will be randomized within your group to receive either DermaVir vaccinations or placebo vaccinations (a placebo is the same vaccine without an active component). You have a 75% chance of actually receiving the DermaVir vaccine and a 25% chance of receiving the placebo vaccine.

If in group 1 you will receive low-dose vaccinations at weeks 1, 7, and 13 (applied over 2 skin sites).

- If in group 2 you will receive high-dose vaccinations at weeks 1, 7, and 13 (applied over 4 skin sites).

- If in group 3 you will receive high-dose vaccinations at entry (week 0) and at weeks 1, 6, 7, 12, and 13 (applied over 4 skin sites).


What
Study treatment is DermaVir or DermaVir placebo. This new DNA vaccine will not be injected into your body like other vaccines. It will be applied to your skin (after a special skin preparation process is completed) in order to target immune cells (known as Langerhans cells) located just under the surface of your skin. These Langerhans cells must pick up the vaccine in order to train your body to fight HIV-1.
Participating Sites (find contact information)
  • Rush-Presbyterian/St.Lukes
  • University of Pittsburgh
  • Case Western/University Hospitals of Cleveland
  • MetroHealth Medical Center
  • University of California
A5244: Treatment Intensification w/Raltegravir on level of Persistent Plasma Viremia

Open

Raltegravir is a new drug (integrase inhibitor) that blocks HIV in a different way than current HIV medicines. This study will focus on HIV-infected people who have "undetectable" viral loads. People who are told that they have "undetectable" viral loads still have HIV that can be measured in their blood using a sensitive test called the single copy assay (SCA). Regular viral load tests only measure down to 50 copies of HIV in each cc of blood, whereas the SCA measures down to 1 copy in each cc of blood. This study will measure the amount of HIV in the blood using the SCA before and after adding raltegravir to current HIV medicines.
Why
The purpose of this study is to find out whether adding the investigational drug called raltegravir lowers the amount of HIV in blood using a sensitive viral load test called a single copy assay. The study will also try to find out if adding raltegravir to HIV medicine causes any side effects or problems. If raltegravir lowers the amount of HIV in blood, this may lead to other studies on how to prevent HIV from continuing in people with the infection.
Who
- CD4 cell count greater than 200
- On HIV treatment that includes at least two NRTIs and either a NNRTI or boosted protease inhibitor (PI) for at least 12 months
- No change in HIV treatment in the last 3 months
- Undetectable viral loads that are less than 50 copies for at least 6 months
- No virologic failure (unsuccessful control of HIV) on a previous drug combination
- No plan to change current anti-HIV medicines within 24 weeks after study entry
- No recent use of immunosuppressive medications
- No recent opportunistic infection or serious illness
- No receipt of any HIV vaccines
How
All participants will continue their current HIV medicines (at least 2 NRTIs and a PI or NNRTI) and will be randomly assigned to either:
- Immediate intensification: add raltegravir for the 1st 12 weeks, and then take placebo for 12 more weeks
- Delayed intensification: add placebo for the first 12 weeks and then take raltegravir for 12 more weeks
The study will last 24 weeks.
What
Raltegravir or placebo will be provided by the study. Current background HIV medicines will not be provided by the study
Participating Sites (find contact information)
  • The Miriam Hospital
  • Columbia Presbyterian Center of New York Presbyterian Hospital
  • Georgetown University Medical Center
  • University of Pennsylvania
  • Cornell Clinical Trials Unit- Chelsea
  • Harbor/ UCLA
  • MetroHealth Medical Center
  • San Francisco General Hospital
  • Emory University
  • Northwestern University
  • University of Colorado Health Science Center
  • University of North Carolina
  • Stanford University Medical School
  • University of Alabama at Birmingham
  • UCLA Care Center
  • University of Rochester Medical Center
  • Community Health Network, Inc.
  • Beth Israel Deaconess Medical Center
  • Washington University (St. Louis)
  • Harvard (Massachusetts General Hospital)
  • Brigham and Women's Hospital
  • Duke University Medical Center
  • University of Pittsburgh
  • Case Western/University Hospitals of Cleveland
  • University of Miami
  • Bellevue Hospital (NYU)
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Immunity Enhancers

HIV harms the immune system. These studies look at innovative ways to help your immune system work better while continuing to treat you with HIV medications.

A5176: Tolerability, Safety, Immunogenicity of LC002 (DermaVir vaccine) in HIV Subjects

Enrolling - Re-Opened

This study will see if the DermaVir vaccine (LC002) is safe and tolerable in people infected with HIV who are currently under treatment with highly active anti-HIV therapy (HAART). DermaVir is given as a patch on the skin. It has not been approved by the Food and Drug Administration for use in treating HIV infection in humans.
Why
This study is being done to find out whether DermaVir is safe in humans and what the best dose is for treating HIV infection. The safety of DermaVir is currently being studied in persons with HIV in another study in Europe.
Who
- Viral load less than 50 copies/mL and not greater than 500 in the past 24 weeks.

- CD4 cell count currently greater than 350. Lowest CD4 count at any time must have been above 250.

- On a stable anti-HIV regimen (containing drugs from at least 2 different classes) without changes or interruptions (for more than 4 consecutive days) for at least 12 weeks.

- Men or women ages 18 - 50 years.

- No history of diabetes, active skin diseases, and chronic autoimmune or bleeding disorders.

- No excessive sun exposure (natural sun or tanning beds) within 2 weeks.

- No treatment with steroid creams on the back and thighs within 2 weeks.
How
Depending on when you enter the study, you will be registered to one of the three groups noted below. You will be randomized within your group to receive either DermaVir vaccinations or placebo vaccinations (a placebo is the same vaccine without an active component). You have a 75% chance of actually receiving the DermaVir vaccine and a 25% chance of receiving the placebo vaccine.

If in group 1 you will receive low-dose vaccinations at weeks 1, 7, and 13 (applied over 2 skin sites).

- If in group 2 you will receive high-dose vaccinations at weeks 1, 7, and 13 (applied over 4 skin sites).

- If in group 3 you will receive high-dose vaccinations at entry (week 0) and at weeks 1, 6, 7, 12, and 13 (applied over 4 skin sites).

Each group's vaccination schedule will be given over a 13-week period, with an additional 48 weeks of follow-up for safety evaluations. Participants will be on study for a total of 61 weeks.
What
Study treatment is DermaVir or DermaVir placebo. This new DNA vaccine will not be injected into your body like other vaccines. It will be applied to your skin (after a special skin preparation process is completed) in order to target immune cells (known as Langerhans cells) located just under the surface of your skin. These Langerhans cells must pick up the vaccine in order to train your body to fight HIV-1.
Participating Sites (find contact information)
  • Rush-Presbyterian/St.Lukes
  • University of Pittsburgh
  • Case Western/University Hospitals of Cleveland
  • MetroHealth Medical Center
  • University of California
A5212: Palifermin for inadequate increase in CD4+ cells

Enrolling

The study will use three different doses of palifermin (recombinant human keratinocyte growth factor) to see which dose causes the greatest increase of CD4+ T cells (a measure of the immune system) to be produced from the thymus gland. Participants will be randomized to one of four treatment arms to receive either placebo or one of three dose levels of palifermin by intravenous (IV) bolus (concentrated dose given through a vein over a brief period of time) for 3 consecutive days.
Why
The purpose of the study is to find out if the study drug, palifermin, is able to increase CD4+ T cell counts by increasing production of these cells in the thymus gland, which is located at the base of the neck. There will also be a placebo group used to see if there is a greater rise in CD4+ T cell counts in at least one of the three palifermin dose groups when compared to the placebo group.
Who
- Viral load less than or equal to 200 copies/mL for at least 6 months
- CD4+ cell count less than 200 for at least 6 months
- On at least three anti-HIV medications for 6 months or longer (does not have to be participant's first regimen)
- Not pregnant or breastfeeding
- No active pancreatitis
- No history of cancer chemotherapy or radiation therapy
- No use of oxandrolones, testosterone, interferons, etc. within 30 days of study entry
How
Participants will be randomly assigned to one of four arms:

Arm A: Palifermin placebo IV bolus daily for 3 days
Arm B: Palifermin low dose IV bolus daily for 3 days
Arm C: Palifermin medium dose IV bolus daily for 3 days
Arm D: Palifermin high dose IV bolus daily for 3 days

Participants will be followed on study for 24 weeks after the completion of the palifermin treatment.
What
Study treatment is palifermin (recombinant human keratinocyte growth factor) or placebo.

In order to make sure that neither the participant nor the study staff knows whether the participant is receiving palifermin or the placebo, all participants will receive three IV boluses each day. An IV bolus is a concentrated dose given through a vein into the bloodstream over a brief period of time. The IV boluses will be given by injection into a heparin lock which is a small catheter tube into the vein with a cap on it. It is kept open with a small amount of heparin solution.
Participating Sites (find contact information)
  • Rush-Presbyterian/St.Lukes
  • Bellevue Hospital (NYU)
  • Case Western/University Hospitals of Cleveland
  • University of Cincinnati
  • Emory University
  • University of Maryland, Institute of Human Virology
  • Columbia Presbyterian Center of New York Presbyterian Hospital
  • MetroHealth Medical Center
  • University of Colorado Health Science Center
  • University of California, San Diego
  • UCLA Care Center
  • University of Southern California
  • Harbor/ UCLA
  • University of Pennsylvania
  • Washington University (St. Louis)
  • Duke University Medical Center
  • The Ohio State University
  • Beth Israel Medical Center
  • Stanford University Medical School
  • University of North Carolina
  • University of Pittsburgh
  • Comprehensive Care Center
  • University of Rochester Medical Center
  • Community Health Network, Inc.
  • University of Washington
  • Indiana University Hospital
  • Wishard Memorial
  • University of Miami
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Women

Women with HIV have unique gynecology, maternity, and metabolic issues. These studies are dedicated to fostering the health of women.

A5190: Safety/Toxicity of Infants of HIV-Infected Women in ART Protocols

Enrolling

This study will follow infants born to HIV-1 infected women while enrolled in international anti-HIV treatment studies.
Why
This study will see if anti-HIV drugs combinations used in studies in diverse areas of the world are safe and well tolerated during pregnancy and breast-feeding and if there are any side effects in infants.
Who
Infants born to HIV-1 infected women who are or become pregnant while enrolled in international anti-HIV treatment studies.
How
Infants will be enrolled in the study within 2 days of birth and will be followed until 18 months of age.
What
This is an observational study. No anti-HIV treatment will be provided to infants through this study.
Participating Sites (find contact information)
  • University of Witwatersrand, Johannesburg
  • University of KwaZulu-Natal, Durban
  • Asociacion Civil IMPACTA Salud y Educacion, Mirafl
  • Asociacion Civil IMPACTA Salud y Education, Lince
  • Les Centres GHESKIO, Port-au-Prince Haiti
  • Chiang Mai University, Chiang Mai
  • National AIDS Research Institute, Pune
  • YRG Centre for AIDS Research and Education, Chennai
  • University of Zimbabwe, Harare
  • University of Malawi, Blantyre
  • Lilongwe Central Hospital Campus, Lilongwe
  • Hospital Nossa Senhora da Conceicao, Porto Alegre
  • Botswana Harvard School of Public Health AIDS Init
  • Botswana Harvard-SPHAI Partnership Scottish Living
  • Asociacion Civil IMPACTA Salud y Education, Lince
  • National AIDS Research Institute, Pune
  • Asociacion Civil IMPACTA Salud y Educacion, Mirafl
  • Lilongwe Central Hospital Campus, Lilongwe
  • Dr. Kotnis Dispensary
  • National Institute of Virology (NARI-NIV Clinic)
  • Oswaldo Cruz Foundation, Rio de Janeiro
  • University of Malawi, Blantyre
A5207: 3 ART Strategies to Reduce NVP-Resistant HIV After Intrapartum Single Dose NVP

Enrolling

This is a study to evaluate three different anti-HIV treatments taken for 7 or 21 days to reduce the development of nevirapine resistance after a single dose of nevirapine (SD NVP) during delivery.
Why
The study will look at whether a 21-day course of anti-HIV therapy is better than a 7-day course for reducing nevirapine resistance in HIV-1 infected pregnant women who receive single-dose nevirapine during delivery. The study will also look at the development of NVP resistance in any HIV-infected infants. The study will also look at the safety and tolerability of the treatments in mothers and infants.
Who
Pregnant HIV-1-infected women 13 years of age or older with a CD4 cell count greater than 250 who have never received anti-HIV therapy.
How
Prior to labor, women will be assigned by chance to receive SD NVP plus either Combivir (3TC/ZDV), Truvada (TDF/FTC), or Kaletra (LPV/r). They will also be assigned by chance to either short (7 days) or longer (21 days) treatment. All anti-HIV drugs will be started at the same time as SD NVP at the onset of active labor.

Mothers will be followed for 96 weeks following delivery. Infants will be followed for 12 weeks after birth or up to 96 weeks if they are found to be HIV infected.
What
SD NVP plus either Combivir (3TC/ZDV), Truvada (TDF/FTC), or Kaletra (LPV/r) will be provided to the mother. Breast-fed infants may also enroll in the A5190 study.
Participating Sites (find contact information)
  • Joint Clinical Research Centre, Kampala
  • YRG Centre for AIDS Research and Education, Chennai
  • University of KwaZulu-Natal, Durban
  • University of Malawi, Blantyre
  • Les Centres GHESKIO, Port-au-Prince Haiti
  • University of Witwatersrand, Johannesburg
  • Les Centres GHESKIO, Port-au-Prince Haiti
  • Joint Clinical Research Centre, Kampala
  • University of KwaZulu-Natal, Durban
  • University of Malawi, Blantyre
A5227: Short Course ART for Prev of Maternal/Child Transmission on Subseq Tx Efficacy

Enrolling

Women who have only taken anti-HIV drugs during pregnancy to prevent their babies from getting HIV have not been eligible for studies on the best treatment to start treating their HIV. This study will look at HIV-positive women who have been previously treated with anti-HIV drugs during pregnancy ("nearly naïve") who need to start medications based on their CD4+ counts and HIV viral load.
Why
The purpose of this study is to see if women who have been treated with anti-HIV drugs during pregnancy can be treated like people who have never received anti-HIV drugs.
Who
- HIV-infected women
- Age 16 years or older
- Must have taken anti-HIV medicines while pregnant to prevent mother to child transmission (pMTCT) of HIV
- Must have taken more than 7 days of anti-HIV medications while pregnant
- Must not have had more than 52 weeks of anti-HIV therapy for pMTCT and must be off treatment for at least 24 weeks
- HIV viral load greater than or equal to 500 copies/mL
- Health care provider must feel it is time to start anti-HIV medications
- Not pregnant or breastfeeding
- Not planning to become pregnant in the next year
How
Treatment with efavirenz (EFV) and Truvada [emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)]
What
Efavirenz and Truvada (FTC/TDF) will be provided by the study. Other similar FDA-approved anti-HIV medications may be substituted, but will not be provided by the study.
Participating Sites (find contact information)
  • University of Alabama at Birmingham
  • Washington University (St. Louis)
  • University of North Carolina
  • Moses H. Cone Hospital-IMPT
  • Cornell Clinical Trials Unit- Chelsea
  • University of California, San Diego
  • Bellevue Hospital (NYU)
  • Brigham and Women's Hospital
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Opportunistic Infections

When people with HIV have an additional infection like CMV or Tuberculosis, there are important treatment questions and side effects to look for. These studies are looking at that unique situation.

A5221: Immediate vs. Deferred ART in Subjects with TB and CD4<200

Enrolling

This is a study to see whether people infected with HIV who are being treated for tuberculosis (TB) should start taking anti-HIV drugs earlier or later compared to when they start their anti-TB drugs.
Why
To compare between people who start anti-HIV drugs as soon as they enter the study and people who start their anti-HIV drugs later the number of people surviving without getting a new AIDS-defining illness.
Who
- HIV-infected males or females at least 13 years old
- CD4 cell count less than 200 (a CD4 cell count is a measure of how well your body can fight infections).
- No more than 7 days total of any anti-HIV drugs (unless it was during pregnancy)
- Recently started TB treatment with rifampin (RIF) or other similar drug
- Cannot have shown resistance to 2 or more anti-TB drugs

NOTE: People who are very ill with advanced AIDS, including those who are hospitalized, are also eligible
How
Participants will receive TB treatment according to World Health Organization (WHO) treatment guidelines and their country's national treatment guidelines.

Participants will be assigned by chance (as if by the flip of a coin) to:
Start anti-HIV drugs within 3 days

OR

Postpone starting anti-HIV drugs until 8-12 weeks after starting anti-TB drugs.

No matter when anti-HIV drugs are started, participants will take these drugs:

- Efavirenz (EFV) (Sustiva or Stocrin) once a day by mouth PLUS
- Emtricitabine (FTC)/Tenofovir (TDF) (Truvada) once a day by mouth

The study will last 48 weeks for each subject.
What
Anti-TB drugs will not be supplied by the study.

EFV will be provided by the study to international sites in the very near future. For now, sites that have access to an approved source of EFV may use that instead. Sites in the U.S. will have to provide EFV themselves.

FTC/TDF(Truvada) will be provided by the study.
Participating Sites (find contact information)
  • Oswaldo Cruz Foundation, Rio de Janeiro
  • Asociacion Civil IMPACTA Salud y Education, Lince
  • Lilongwe Central Hospital Campus, Lilongwe
  • YRG Centre for AIDS Research and Education, Chennai
  • Hospital Nossa Senhora da Conceicao, Porto Alegre
  • University of Witwatersrand, Johannesburg
  • University of KwaZulu-Natal, Durban
  • Bellevue Hospital (NYU)
  • University of California, San Diego
  • San Francisco General Hospital
  • University of Southern California
  • Harbor/ UCLA
  • The Miriam Hospital
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Hepatitis

People with HIV may also be infected with other viruses, such as Hepatitis B or Hepatitis C. There are trials for the treatment of co-infected patients.

A5232: Optimizing Vaccine Response in HIV-1, HCV, & Co-Infected Subjects

Enrolling

This is a pilot study investigating the extent of immune defects in people who have hepatitis C (HCV), HIV, or both. This will be done by immunizing people with both diphtheria/tetanus toxoid and hepatitis A and B vaccines and evaluating immunological response.
Why
To study immune defects in people who are infected with hepatitis C, HIV, or both, and to see if these defects predict how these participants respond to vaccines.
Who
- 18 to 65 years old
- Hepatitis A antibody negative, hepatitis B surface antibody negative, hepatitis B surface antigen negative
- Tetanus antibody positive

Participants will be divided into the following arms based on their HCV/HIV-1 status:

- Arm A: Chronic HCV infection defined as PCR positive without previous HCV-based therapy and without the presence of severe liver disease
o These participants will be HIV-1 negative.

- Arm B: Chronic HIV-1 infection, CD4+ T-cell count = 300 cells/mm3, no prior or current opportunistic infection, and anti-HIV therapy naïve with no indication for the need for HIV-1 therapy.
o These participants will be HCV negative.

- Arm C: HCV/HIV-1 coinfection as defined above in Arms A and B.

How
Participants in each arm will be immunized with diphtheria/tetanus toxoid on day 0, and with combined hepatitis A/hepatitis B vaccine on days 0, 7, and 21 (accelerated vaccination protocol) given as injections.

Participants will be on study for a total of 24 weeks
What
Diphtheria/tetanus toxoid and hepatitis A-hepatitis B vaccine (Twinrix) will be provided by the study
Participating Sites (find contact information)
  • University of Maryland, Institute of Human Virology
  • Duke University Medical Center
  • University of Cincinnati
  • Harvard (Massachusetts General Hospital)
  • Brigham and Women's Hospital
  • Columbia Presbyterian Center of New York Presbyterian Hospital
  • University of Puerto Rico
  • University of California, San Diego
  • Johns Hopkins University
  • Washington University (St. Louis)
  • San Francisco General Hospital
  • University of Rochester Medical Center
  • Community Health Network, Inc.
  • The Ohio State University
  • Bellevue Hospital (NYU)
  • Case Western/University Hospitals of Cleveland
  • MetroHealth Medical Center
  • University of Colorado Health Science Center
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Neurologic Complications

HIV infection may cause nervous system problems such as numbness and cognitive problems. These studies look at treatments for the problems.

A5235: Trial of Minocycline for HIV-Associated Cognitive Impairment

Enrolling

This study will look at HIV-infected people who have problems with mental function. This will be determined by the results of objective neuropsychological tests. The study has 2 steps: in Step 1 (double-blind) participants will be randomized to receive either the study drug, minocycline, or a placebo for 24 weeks, and in Step 2 (open-label) they will have the option to receive minocycline for additional 24 weeks.
Why
This study is being done to see whether taking minocycline improves mental function and is safe for people infected with HIV.
Who
- Must have problems with mental function as determined by the results of objective neuropsychological tests.

- On stable anti-HIV therapy for at least 16 weeks and be willing to stay on those same HIV drugs for the first 24 weeks of the study.

- Willing and able to have 2 lumbar punctures or "spinal taps," in which a small amount of fluid will be taken from the spine.

- Able to swallow medications with an 8 ounce glass of water and be able to sit or stand for at least 2 hours after.

- 18 to 65 years old.

- Must not have active AIDS-related infection.

- Must not have some specific neurological or medical disorders.
How
Participants will be randomized 1:1 (as in the flip of a coin) to receive either:

Step 1: Minocycline: one 100mg tablet orally every 12 hours

OR

Placebo (which is like a sugar pill): orally every 12 hours

Participants will take this for 24 weeks. Neither the participant nor the study doctor or nurse will know which is being taken.

After that time, participants will be offered the choice to participate in Step 2 for an additional 24 weeks. This step is open-label; all participants will receive the actual drug, minocycline.

During this study participants will come to the clinic frequently for close monitoring. Participants will be assessed at pre-entry and at week 24 using the same neuropsychological tests and spinal taps, to document any change that may have occurred since starting the study medication
What
Minocycline/placebo will be provided by the study.
Participating Sites (find contact information)
  • University of Washington
  • Harvard (Massachusetts General Hospital)
  • University of North Carolina
  • Bellevue Hospital (NYU)
  • University of Pennsylvania
  • Hawaii ACTU
  • Johns Hopkins University
  • Beth Israel Medical Center
  • University of Colorado Health Science Center
  • UCLA Care Center
  • University of Rochester Medical Center
  • Northwestern University
  • University of California, San Diego
  • Washington University (St. Louis)
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Side Effects

We know that many drugs used to successfully treat HIV have side effects. The following studies look at ways to treat the most common of these side effects.

A5229: Uridine Supplementation in HIV Lipoatrophy

Enrolling - Re-Opened

This is a study of the effects of uridine supplement (NucleomaxXr) on patients with body fat changes who are currently taking anti-HIV medications. NucleomaxX is a powdered nutritional food supplement that provides the body with a substance called `uridine'.
Why
The purpose of this study is to see if taking uridine supplementation (NucleomaxX) will reverse fat loss (lipoatrophy) in the face, arms, legs, or buttocks in HIV-infected persons. The study will also test to see if NucleomaxX is safe and how well it is tolerated.
Who
- Viral load less than 5000 copies/mL

- Currently taking anti-HIV drugs containing stavudine (d4T) or zidovudine (ZDV) for at least 12 weeks and planning to continue the regimen

- Clinical diagnosis of fat loss in face, arms, legs, or buttocks
How
Patients will be assigned by chance to one of two treatment groups for 48 weeks.
Arm A: NucleomaxX: 1 sachet three times per day, every other day.

Arm B: Placebo for NucleomaxX: 1 sachet three times per day, every other day.

Patients will not know if they are in Arm A or B.
What
NucleomaxX is a nutritional supplement in the form of powder that elevates the body's level of a substance called uridine. It comes in a sachet (packet) and is mixed in with juice, milk, or water. The placebo sachets will be similar to active substance in weight, taste, and appearance.
Participating Sites (find contact information)
  • Emory University
  • University of Southern California
  • Bellevue Hospital (NYU)
  • Columbia Presbyterian Center of New York Presbyterian Hospital
  • Comprehensive Care Center
  • University of California
  • Indiana University Hospital
  • Wishard Memorial
  • University of Washington
  • University of Washington General Clinical Research
  • Harbor/ UCLA
  • University of Puerto Rico
  • University of California, San Diego
  • San Mateo County AIDS Program
  • Santa Clara Valley Medical Center
  • University of Alabama at Birmingham
  • Cook County Bureau of Health Services
  • Hawaii ACTU
  • Northwestern University
  • University of Texas, Galveston
  • The Ohio State University
  • University of Pittsburgh
  • The Miriam Hospital
  • University of Rochester Medical Center
  • Community Health Network, Inc.
  • Washington University (St. Louis)
  • Beth Israel Medical Center
  • Cornell Clinical Trials Unit
  • Cornell Clinical Trials Unit- Chelsea
  • Case Western/University Hospitals of Cleveland
  • MetroHealth Medical Center
  • Rush-Presbyterian/St.Lukes
  • University of North Carolina
  • UCLA Care Center
  • Duke University Medical Center
  • University of Colorado Health Science Center
  • University of Pennsylvania
  • University of Minnesota
  • University of Cincinnati
  • Johns Hopkins University
  • Stanford University Medical School
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