select one of the following sections:

Categories of Trials | Treatment Naive | Treatment Experienced | Immunity Enhancers | Women |
Opportunistic Infections | Hepatitis | Neurologic Complications | Side Effects

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 Clinical Research Site 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.

• A5001: ACTG Longitudinal Linked Randomized Trials (ALLRT) Protocol
• A5257: A Phase III Comparative Study of Three Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)-Sparing Antiretroviral Regimens for Treatment-Naïve HIV-1-Infected Volunteers
• A5258: Chloroquine for Reducing HIV-Associated Immune Action 

A5001: ACTG Longitudinal Linked Randomized Trials (ALLRT) Protocol

Enrolling

Prospectively planned series of cross-protocol analyses.

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 randomized ACTG trials.

How

Clinical and laboratory evaluations every 16 weeks.

What

Long-term observational study

Participating ACTG Sites (find contact information)
Source: February 4, 2010 DAIDS-ES Protocol Registration Report

• AIDS Community Health Ctr. ACTG CRS
• AIDS Care CRS
• Alabama Therapeutics CRS
• Beth Israel Deaconess Med. Ctr., ACTG CRS
• BMC ACTG CRS
• Brigham and Women's Hosp. ACTG CRS
• Bronx-Lebanon Hosp. Ctr. CRS
• Case CRS
• Cooper Univ. Hosp. CRS
• Cornell CRS
• Duke Univ. Med. Ctr. Adult CRS
• Georgetown University CRS (GU CRS)
• Harbor-UCLA Med. Ctr. CRS
• Henry Ford Hosp. CRS
• HIV Prevention & Treatment CRS
• Hosp. of the Univ. of Pennsylvania CRS
• Houston AIDS Research Team CRS
• IHV Baltimore Treatment CRS
• Johns Hopkins Adult AIDS CRS
• Massachusetts General Hospital ACTG CRS
• MetroHealth CRS
• Moses H. Cone Memorial Hosp. CRS
• New Jersey Medical School- Adult Clinical Research Ctr. CRS
• Northwestern University CRS
• NY Univ. HIV/AIDS CRS
• Peabody Health Ctr. CRS
• Pitt CRS
• Puerto Rico-AIDS CRS
• Rush Univ. Med. Ctr. ACTG CRS
• Stanford CRS
• The Miriam Hosp. ACTG CRS
• The Ohio State Univ. AIDS CRS
• The Ponce de Leon Ctr. CRS
• UCLA CARE Center CRS
• UCSD, AVRC CRS
• UCSF AIDS CRS
• UNC AIDS CRS
• Univ. of Cincinnati CRSUniv. of Miami AIDS CRS
• Univ. of Rochester ACTG CRS
• University of Colorado Hospital CRS
• University of Washington AIDS CRS
• USC CRS
• Vanderbilt Therapeutics CRS
• Washington U CRS
• Wayne State Univ. CRS 

A5257: A Phase III Comparative Study of Three Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)-Sparing Antiretroviral Regimens for Treatment-Naïve HIV-1-Infected Volunteers

 Enrolling

This study is for people who are HIV infected but have never taken HIV medications.  Participants will receive one of three anti-HIV treatment regimens that do not include an NNRTI type of drug.  The regimens include emtricitabine/tenofovir (also known as FTC/TDF or Truvada) plus atazanavir boosted with ritonavir, darunavir boosted with ritonavir, or raltegravir.

Why

The purpose of this study is to learn whether the three medication combinations work equally well in people who have never taken HIV medications before.  The study will also look at how easy the medications are to take and their side effects.

Who

• HIV-1 infected people at least 18 years of age
• Have not taken HIV medication
• No resistance to the type (class) of medications provided by the study on a test called a genotype.
• HIV viral load (HIV level) currently 1000 copies/mL or higher

How 

Participants will be assigned (by chance) to one of the following treatments:
Arm A: Atazanavir + ritonavir once daily + Truvada once daily
Arm B: Raltegravir twice daily + Truvada once daily
Arm C: Darunavir  + ritonavir once daily + Truvada once daily

Participants will be in this study about 2 years after the last person starts the study.

What 

Truvada, raltegravir, atazanavir, and darunavir are provided by the study, but ritonavir must be obtained through a primary care physician.  Participants may be reimbursed for the cost of the ritonavir co-payment.

Participating ACTG Sites (find contact information)
Source: February 4, 2010 DAIDS-ES Protocol Registration Report

•   AIDS Community Health Ctr. ACTG CRS
• Alabama Therapeutics CRS
• Beth Israel Deaconess Med. Ctr., ACTG CRS
• BMC ACTG CRS
• Brigham and Women's Hosp. ACTG CRS
• Bronx-Lebanon Hosp. Ctr. CRS
• Case CRS
• Cooper Univ. Hosp. CRS
• Cornell CRS
• Denver Public Health CRS
• Duke Univ. Med. Ctr. Adult CRS
• Georgetown University CRS (GU CRS)
• Harbor-UCLA Med. Ctr. CRS
• Harlem ACTG CRS
• Henry Ford Hosp. CRS
• HIV Prevention & Treatment CRS
• Hosp. of the Univ. of Pennsylvania CRS
• Houston AIDS Research Team CRS
• IHV Baltimore Treatment CRS
• Johns Hopkins Adult AIDS CRS
• Massachusetts General Hospital ACTG CRS
• MetroHealth CRS
• Moses H. Cone Memorial Hosp. CRS
• New Jersey Medical School- Adult Clinical Research
• Northwestern University CRS
• NY Univ. HIV/AIDS CRS
• Peabody Health Ctr. CRS
• Pitt CRS
• Puerto Rico-AIDS CRS
• Rush Univ. Med. Ctr. ACTG CRS
• Stanford CRS
• The Miriam Hosp. ACTG CRS
• The Ohio State Univ. AIDS CRS
• The Ponce de Leon Ctr. CRS
• The Research & Education Group-Portland CRS
• UCLA CARE Center CRS
• UCSF AIDS CRS
• UNC AIDS CRS
• Univ. of Cincinnati CRS
• Univ. of Miami AIDS CRS
• Univ. of Rochester ACTG CRS
• University of Colorado Hospital CRS
• University of Washington AIDS CRS
• USC CRS
• Vanderbilt Therapeutics CRS
• Virginia Commonwealth Univ. Medical Ctr. CRS
• Washington U CRS
• Wayne State Univ. CRS

Participating International Maternal-Pediatric-Adolescent AIDS Clinical Trials (IMPAACT)Sites

• NY Blood Ctr./Bronx CRS

A5258: Chloroquine for Reducing HIV-Associated Immune Action

Enrolling

This is a randomized, double-blind, placebo controlled study to evaluate the use of chloroquine in chronically HIV-infected patients who are not receiving anti-HIV therapy.

Why

The purpose of this study is to learn how well chloroquine, an FDA-approved medication used to treat malaria, reduces the level of activated CD8 T cells. Increased activation of CD8 T cells has been associated with progression of HIV disease.

Who

- HIV-infected men and women between the ages of 18-65
- CD4 count of 400 and above
- HIV viral load greater than 20,000 copies/mL
- Not taking anti-HIV drugs for at least 6 months before study and not likely to start within 6 months

How

Participants will be assigned by chance to one of two treatment groups:

Group A: 12 weeks of chloroquine followed by 12 weeks of placebo (a look-alike pill that does not contain any drug).

OR

Group B: 12 weeks of placebo followed by 12 weeks of chloroquine.
 
The study will include up to 24 weeks of treatment with an additional 4 weeks of safety follow-up.

What

Cholorquine will be provided by the study.

Participating ACTG Sites (find contact information)
Source: February 4, 2010 DAIDS-ES Protocol Registration Report

• Alabama Therapeutics CRS
• Case CRS
• Cornell CRS
• Georgetown University CRS (GU CRS)
• Hosp. of the Univ. of Pennsylvania CRS
• Johns Hopkins Adult AIDS CRS
• MetroHealth CRS
• Northwestern University CRS
• UCLA CARE Center CRS
• UCSD, AVRC CRS
• Univ. of Cincinnati CRS
• University of Colorado Hospital CRS
• Vanderbilt Therapeutics CRS
• Washington U CRS 

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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
• A5128: Consent for Stored Human Biological Materials for Currently Unspecified Analysis
• A5230: Kaletra for Virologic Relapse on NNRTI-Containing Regimens
• A5234:  Directly Observed Therapy vs. Standard of Care for Patients with First Virologic Failure on NNRTI
• A5241: Optimized Treatment that Includes or Omits NRTIs (OPTIONS) Trial:
  A Randomized Strategy Study for HIV-1 Infected Treatment-Experienced Subjects Using the cPSS to Select an Effective Regimen

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 ACTG study.

How

Blood specimen collected at one time point only.

What

Blood stored for future testing.

Participating ACTG Sites (find contact information)
Source: February 4, 2010 DAIDS-ES Protocol Registration Report

• AIDS Community Health Ctr. ACTG CRS
• Alabama Therapeutics CRS
• Beth Israel Deaconess Med. Ctr., ACTG CRS
• BMC ACTG CRS
• Brigham and Women's Hosp. ACTG CRS
• Bronx-Lebanon Hosp. Ctr. CRS
• Case CRS
• Cooper Univ. Hosp. CRS
• Cornell CRS
• Denver Public Health CRS
• Duke Univ. Med. Ctr. Adult CRS
• Georgetown University CRS (GU CRS)
• Harbor-UCLA Med. Ctr. CRS
• Henry Ford Hosp. CRS
• HIV Prevention & Treatment CRS
• Hosp. of the Univ. of Pennsylvania CRS
• Houston AIDS Research Team CRS
• IHV Baltimore Treatment CRS
• Johns Hopkins Adult AIDS CRS
• Massachusetts General Hospital ACTG CRS
• MetroHealth CRS
• Moses H. Cone Memorial Hosp. CRS
• New Jersey Medical School- Adult Clinical Research
• Northwestern University CRS
• NY Univ. HIV/AIDS CRS
• Peabody Health Ctr. CRS
• Pitt CRS
• Puerto Rico-AIDS CRS
• Rush Univ. Med. Ctr. ACTG CRS
• Stanford CRS
• The Miriam Hosp. ACTG CRS
• The Ohio State Univ. AIDS CRS
• The Ponce de Leon Ctr. CRS
• The Research & Education Group-Portland CRS
• UCLA CARE Center CRS
• UCSD, AVRC CRS
• UCSF AIDS CRS
• UNC AIDS CRS
• Univ. of Cincinnati CRS
• Univ. of Miami AIDS CRS
• Univ. of Rochester ACTG CRS
• University of Colorado Hospital CRS
• University of Washington AIDS CRS
• USC CRS
• Vanderbilt Therapeutics CRS
• Vanderbilt Therapeutics Clinical Research Site
• Virginia Commonwealth Univ. Medical Ctr. CRS
• Washington U CRS
• Wayne State Univ. CRS

A5230: Kaletra for Virologic Relapse on NNRTI-Containing Regimens

 Enrolling

This one-arm pilot study will explore the safety and efficacy of using lopinavir/ritonavir (LPV/r, also known as Kaletra or Aluvia) alone to treat persons who are failing their current NNRTI regimen (type of anti-HIV therapy) and have never received protease inhibitors before. All study participants will receive Kaletra alone. Upon virologic failure, emtricitabine/tenofovir (FTC/TDF, also known as Truvada) will be added to the treatment. 

Why

The purpose of the study is to evaluate the safety and effectiveness of Kaletra therapy alone in people whose first anti-HIV drug regimen is no longer working.

Who

• Received continuous treatment with a three-drug, NNRTI-containing anti-HIV regimen for at least 6 months before study entry
• HIV viral load between 1000 and 200,000 copies/mL
• No protease inhibitor treatment before entering the study

• No history of active hepatitis B

How

Participants will discontinue their current NNRTI-based regimen, which is not working at the time of entry, and start the following anti-HIV treatment:

Step 1: Monotherapy (entry up to week 104): Kaletra orally twice daily  
           If HIV is not suppressed by Kaletra (virologic failure):

Step 2: Intensification (beginning after virologic failure and continuing through week 104):  Continue Kaletra and also receive Truvada orally once daily.

What

Kaletra and Truvada will be provided by the study.

Participating ACTG Sites (find contact information)
 Source: February 4, 2010 DAIDS-ES Protocol Registration Report

• Chiang Mai Univ. ACTG CRS
• Kilimanjaro Christian Medical CRS
• University of North Carolina Lilongwe CRS
• Wits HIV CRS
• YRG CARE Medical Ctr., VHS CRS

A5234:  Directly Observed Therapy vs. Standard of Care for Patients with First Virologic Failure on NNRTI

Enrolling

This is a study of people experiencing virologic failure on their first non-nucleoside reverse transcriptase (NNRTI)-based regimen of anti-HIV drugs. At entry, all participants will switch to one of the study courses of therapy  and will be randomized to modified directly observed therapy (mDOT) versus ”normal” self-administered therapy.

Why

The study will measure the effect of mDOT versus self-administered therapy on response to a anti-HIV regimen

Who

• HIV-1 infected
• Experiencing virologic failure (HIV viral load greater than 1,000 copies/mL) on the first NNRTI-based anti-HIV regimen
• No prior treatment with a protease inhibitor (type of anti-HIV medicine)
• Ability to identify a close friend or relative who is willing to serve as a partner for the participant.  
        -Partner will sign a consent form, act as a positive support system, and will ask clinic staff for help if the participant is having difficulty with adherence.
• No intention to relocate away from current geographical area of residence for the duration of study (52 weeks).
• No current active tuberculosis

How

At entry, participants will stop their failing NNRTI-based regimen and will switch to one of the courses of therapy listed below: 
• emtricitabine/tenofovir (Truvada) once daily + lopinavir/ritonavir twice daily  
• tenofovir once daily + zidovudine twice daily + lopinavir/ritonavir twice daily

NOTE: The choice of which of the two therapies above will be made by the site Investigator and the participant based on treatment history.

Participants will then be randomized (chosen by chance) to either:
• Normal therapy (self administration of study medications) for 52 weeks. 
                  OR
• Modified directly observed therapy (mDOT) for 24 weeks followed by normal therapy for an additional 28 weeks.

Participants randomized to mDOT will take medications with the help of the chosen friend or family member (mDOT partner) who has completed the study-administered mDOT training program.

For the first 24 weeks of the study, the mDOT partner will help the participant with the drugs 5 days a week and the participant will self-administer treatment on weekends and holidays. 

Adherence will be measured using Medication Event Monitoring System (MEMS) caps (electronic bottle caps that will record when they are opened), self-reports (that you fill out daily), and medication diaries completed by your mDOT partner, if you have one. 

What

• Truvada, lopinavir/ritonavir, tenofovir, and emtricitabine will be provided by the study.
• zidovudine will not be provided by the study and must be obtained by the site. 

Participating ACTG Sites (find contact information)
Source: February 4, 2010 DAIDS-ES Protocol Registration Report

• Asociacion Civil Impacta Salud y Educacion - Miraf
• Investigaciones Medicas en Salud - INMENSA. Lince
• Joint Clinical Research Ctr. CRS
• Les Centres GHESKIO CRS
• Panama Med. and Research Ctr. CRS
• Wits HIV CRS

 A5241: Optimized Treatment that Includes or Omits NRTIs (OPTIONS) Trial: A Randomized Strategy Study for HIV-1 Infected Treatment-Experienced Subjects Using the cPSS to Select an Effective Regimen

Enrolling

This is a study to evaluate the benefit of adding nucleoside reverse transcriptase inhibitors (NRTIs, a type of anti-HIV drug) to a new anti-HIV regimen, among triple-class anti-HIV treatment-experienced or resistant individuals. The study will make available several new drugs, including raltegravir, darunavir, tipranavir, etravirine, enfuvirtide and, if a person has a specific type of virus, maraviroc. Two strategies will be evaluated: 1) including versus omitting NRTIs in a new regimen and 2) using a drug resistance score called the cPSS to help predict which drugs will work best.

Why

This study will look at whether newer anti-HIV drugs are safe and effective in a group of HIV-infected persons whose current HIV medicines are not working. The study will also test whether NRTIs are needed to treat HIV in persons failing their current medicines. Finally, this study will test whether the cPSS score is able to predict which drugs will work best in people whose virus is resistant to specific HIV medications.

Who

- HIV-1-infected people at least 16 years of age
- HIV viral load (HIV level) currently 1,000 copies/mL or higher 
- Currently on an HIV drug regimen that includes a protease inhibitor.
- Have resistance to multiple types of HIV medications OR had exposure to multiple types of HIV medications 
- Never received an integrase inhibitor
- No hepatitis B infection

How

Part 1: Participants will remain on their current anti-HIV regimen while resistance testing, cPSS score, the type of virus, and previous medication history are reviewed by study physicians. The study physicians will recommend one or more study drug combinations that will give a cPSS score above 2. Possible combinations will include at least three study drugs. All but one of the drugs will be taken in pill form; one will need to be injected under the skin twice a day. The study physicians will also recommend a combination of NRTIs based on the results of the resistance test and the participant’s past treatment history.

Once the participant and primary study doctor choose a study drug combination and a possible NRTI combination, the participant will be randomized (chosen as if by a flip of a coin) to receive or not receive NRTIs. 

Part 2:  Participants will receive the new study medicines (with or without NRTIs, depending on the randomization) for 48 weeks. During this time, they will have tests to make sure the new drugs are safe and are working. If the new drugs do not work to make the viral load low enough, another resistance test will be done as part of the study.

What

The anti-HIV drugs that will be provided through the study are:  enfuvirtide, raltegravir, darunavir, tipranavir, etravirine, and maraviroc. Which of these drugs are recommended for the participant depends on the results of the testing done in Part 1 of the study. Although they may be recommended by the study doctors, NRTIs and ritonavir will not be provided through the study.

Participating ACTG Sites (find contact information)
Source: February 4, 2010 DAIDS-ES Protocol Registration Report

• AIDS Community Health Ctr. ACTG CRS
• Alabama Therapeutics CRS
• Beth Israel Deaconess Med. Ctr., ACTG CRS
• BMC ACTG CRS
• Brigham and Women's Hosp. ACTG CRS
• Bronx-Lebanon Hosp. Ctr. CRS
• Case CRS
• Cooper Univ. Hosp. CRS
• Cornell CRS
• Denver Public Health CRS
• Duke Univ. Med. Ctr. Adult CRS
• Georgetown University CRS (GU CRS)
• Harlem ACTG CRS
• Henry Ford Hosp. CRS
• HIV Prevention & Treatment CRS
• Hosp. of the Univ. of Pennsylvania CRS
• Houston AIDS Research Team CRS
• IHV Baltimore Treatment CRS
• Johns Hopkins Adult AIDS CRS
• Massachusetts General Hospital ACTG CRS
• MetroHealth CRS
• Moses H. Cone Memorial Hosp. CRS
• New Jersey Medical School- Adult Clinical Research
• Northwestern University CRS
• NY Univ. HIV/AIDS CRS
• Peabody Health Ctr. CRS
• Pitt CRS
• Puerto Rico-AIDS CRS
• Rush Univ. Med. Ctr. ACTG CRS
• Stanford CRS
• The Miriam Hosp. ACTG CRS
• The Ohio State Univ. AIDS CRS
• The Ponce de Leon Ctr. CRS
• The Research & Education Group-Portland CRS
• UCSD, AVRC CRS
• UCSF AIDS CRS
• UNC AIDS CRS
• Univ. of Cincinnati CRS
• Univ. of Rochester ACTG CRS
• University of Colorado Hospital CRS
• University of Washington AIDS CRS
• USC CRS
• Vanderbilt Therapeutics CRS
• Virginia Commonwealth Univ. Medical Ctr. CRS
• Washington U CRS
• Wayne State Univ. CRS 

 Participating International Maternal-Pediatric-Adolescent AIDS Clinical Trials (IMPAACT) Sites

• Boston Medical Center Ped. HIV Program NICHD CRS
• Bronx-Lebanon Hosp. IMPAACT CRS
• Children's Hosp. of Boston NICHD CRS
• Children’s Diagnostic & Treatment Center, Inc. ATN CRS
• Children’s National Med. Ctr. ATN CRS
• Columbia IMPAACT CRS
• DUMC Ped. CRS
• Harbor UCLA Medical Ctr. NICHD CRS
• Howard Univ. Washington DC NICHD CRS
• Johns Hopkins Univ. Baltimore NICHD CRS
• Miller Children's Hosp. Long Beach CA NICHD CRS
• NJ Med. School CRS
• NYU NY NICHD CRS
• South Florida CDC Ft Lauderdale NICHD CRS
• St. Jude/UTHSC CRS
• Texas Children's Hosp. CRS
• Tulane Univ. New Orleans NICHD CRS
• Univ. of California San Francisco NICHD CRS
• Univ. of Miami Ped. Perinatal HIV/AIDS CRS
• Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
• USC LA NICHD CRS 

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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. 

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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.

A5240: HPV Vaccine in HIV-Infected Females

Enrolling

This study is the first to test the human papillomavirus (HPV) vaccine (called Gardasil) in females infected with HIV. This study will see whether the HPV vaccine, when given in three separate doses, is safe and tolerable in females infected with HIV.

Why

Human papillomavirus is the most common sexually transmitted disease in the United States and worldwide. There are over 90 types of HPV that infect humans. Some of these types infect the genital and anal areas where the infection causes genital and anal warts. It also causes cancer of the cervix (the opening of the uterus) in females. HPV infection may be more severe and harder to treat in people infected with HIV. The FDA has approved an HPV vaccine (Gardasil) directed against four types of HPV which are the most common causes of genital warts and cervical cancer. The study will evaluate the safety of the HPV vaccine and will also check if the vaccine can help the body make substances in response to the vaccination to help fight off disease caused by HPV.

Who

- HIV-infected females ages 13 to 45.
- Any T-cell count and any HIV viral load.
- If taking anti-HIV drugs, must be on the same combination of drugs for at least 12 weeks before the study entry visit. (Persons do not need to be on anti-HIV drugs to be eligible for this study.)
- No cervical cancer or very abnormal Pap test.
- No genital warts within 180 days of the study entry visit.
- No prior vaccinations for HPV.

How

The HPV vaccine will be given in three separate doses: at day 0, week 8, and week 24. Participants will be followed for about 1-1/2 years.

What

Study treatment is quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine, Gardasil, which means that the vaccine is directed at four types of HPV. Gardasil will be provided by the study. Anti-HIV drugs that the participant may be taking will not be provided by the study.

Participating ACTG Sites (find contact information)
Source: February 4, 2010 DAIDS-ES Protocol Registration Report

• AIDS Community Health Ctr. ACTG CRS
• Alabama Therapeutics CRS
• Beth Israel Deaconess Med. Ctr., ACTG CRS
• BMC ACTG CRS
• Brigham and Women's Hosp. ACTG CRS
• Case CRS
• Cooper Univ. Hosp. CRS
• Cornell CRS
• Denver Public Health CRS
• Duke Univ. Med. Ctr. Adult CRS
• Georgetown University CRS (GU CRS)
• Harbor-UCLA Med. Ctr. CRS
• Henry Ford Hosp. CRS
• HIV Prevention & Treatment CRS
• Hosp. of the Univ. of Pennsylvania CRS
• Houston AIDS Research Team CRS
• IHV Baltimore Treatment CRS
• Instituto de Pesquisa Clinica Evandro Chagas CRS (
• Johns Hopkins Adult AIDS CRS
• Massachusetts General Hospital ACTG CRS
• MetroHealth CRS
• Moses H. Cone Memorial Hosp. CRS
• New Jersey Medical School- Adult Clinical Research
• Northwestern University CRS
• NY Univ. HIV/AIDS CRS
• Peabody Health Ctr. CRS
• Pitt CRS
• Puerto Rico-AIDS CRS
• Rush Univ. Med. Ctr. ACTG CRS
• Stanford CRS
• The Miriam Hosp. ACTG CRS
• The Ohio State Univ. AIDS CRS
• The Ponce de Leon Ctr. CRS
• The Research & Education Group-Portland CRS
• Thomas Jefferson Univ. Med. Ctr. CRS
• UCLA CARE Center CRS
• UCSD, AVRC CRS
• UCSF AIDS CRS
• UNC AIDS CRS
• Univ. of Cincinnati CRS
• Univ. of Miami AIDS CRS
• Univ. of Rochester ACTG CRS
• University of Colorado Hospital CRS
• University of Washington AIDS CRS
• USC CRS
• Vanderbilt Therapeutics CRS
• Virginia Commonwealth Univ. Medical Ctr. CRS
• Washington U CRS
• Wits HIV CRS 

 Participating International Maternal-Pediatric-Adolescent AIDS Clinical Trials (IMPAACT) Sites

• Boston Medical Center Ped. HIV Program NICHD CRS
• Children's Hosp. of Boston NICHD CRS
• Columbia IMPAACT CRS
• DUMC Ped. CRS
• Howard Univ. Washington DC NICHD CRS
• Jacobi Med. Ctr. Bronx NICHD CRS
• Miller Children's Hosp. Long Beach CA NICHD CRS
• Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
• NJ Med. School CRS
• Rush Univ. Cook County Hosp. Chicago NICHD CRS
• San Juan City Hosp. PR NICHD CRS
• South Florida CDC Ft Lauderdale NICHD CRS
• St. Jude/UTHSC CRS
• SUNY Stony Brook NICHD CRS
• Texas Children's Hosp. CRS
• Tulane Univ. New Orleans NICHD CRS
• UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
• UCSD Maternal, Child, and Adolescent HIV CRS
• Univ. of Colorado Denver NICHD CRS
• Univ. of Florida Jacksonville NICHD CRS
• Univ. of Miami Ped. Perinatal HIV/AIDS CRS
• Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
• USC LA NICHD CRS
• WNE Maternal Pediatric Adolescent AIDS CRS

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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.

• A5253:  Sensitivity and Specificity of Tuberculosis (TB) Diagnostics
• A5255:  Faster AFB Identification, Speciation of TB, and Evaluation of Drug Resistance in HIV-Infected Persons Initiating TB Treatment
• A5259: Weekly Rifapentine/INH vs. Daily Isoniazid for the Treatment of Latent Tuberculosis (TB)
• A5267 A Phase I, Safety, Tolerability, and Pharmacokinetic Interaction Study of Single-Dose TMC207 and Efavirenz in Healthy Volunteers

A5253:  Sensitivity and Specificity of Tuberculosis (TB) Diagnostics

Enrolling

This is an observational study designed to find a better way to diagnose tuberculosis (TB) in HIV-infected people who are not currently taking anti-HIV or anti-TB medications.

Why

To see if additional tests to diagnose TB will identify more HIV-positive people with active TB than the standard testing that is normally done.

Who

- HIV-infected men and women at least 13 years of age.
- No anti-HIV or anti-TB drugs taken in the 3 months before screening.

How

- Participants will be screened for TB.  This will include a medical and medication history, physical exam, blood tests, collection of sputum for testing, and a chest x-ray.
- People diagnosed with TB will be referred for treatment.

What

This is an observational study, which means no medicines are provided.

Participating ACTG Sites (find contact information)
Source: February 4, 2010 DAIDS-ES Protocol Registration Report

• Asociacion Civil Impacta Salud y Educacion - Miraflores, CRS
• BJ Medical College CRS
• Investigaciones Médicas en Salud - INMENSA. Lince CRS
• Soweto ACTG CRS
• Wits HIV CRS 

A5255:  Faster AFB Identification, Speciation of TB, and Evaluation of Drug Resistance in HIV-Infected Persons Initiating TB Treatment

Enrolling

This is a study to see whether tuberculosis (TB) can be accurately detected more quickly in HIV-infected patients using new rapid diagnostic tests. 

Why

To compare the results from standard and new diagnostic TB tests.

Who

--HIV-infected males or females at least 13 years old
-Expecting to start TB treatment within 30 days or have had less than 7 days of TB treatment
 

How

Participants will provide 1-2 sputum samples at study entry.

Study clinics will review test results by week 12 and may ask some participants to return for a follow-up visit by week 36.

The study will last for up to 36 weeks for each participant.

What

No treatment will be provided through or required by the study.

Participating ACTG Sites (find contact information)
Source: February 4, 2010 DAIDS-ES Protocol Registration Report

• Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
• Wits HIV CRS 

A5259: Weekly Rifapentine/INH vs. Daily Isoniazid for the Treatment of Latent Tuberculosis (TB)

Enrolling

This study is a comparison of once weekly rifapentine and isoniazid (INH) given for 3 months under direct observation (3RPT/INH) versus once daily INH for 9 months self-administered (9INH). Within the ACTG, the study will be conducted in HIV-infected persons who are tuberculinskin test (TST)-positive or household or other close contacts of active TB cases, and  require treatment of their latent infection to prevent the development of active TB.

Why

This study is being done to evaluate the effectiveness of weekly rifapentine and INH compared to daily INH in preventing TB in persons at high-risk of developing TB, including HIV-infected persons.

Who

- HIV-infected people greater than 13 years old
- TB skin test positive (greater than 5 millimeters),
or,
- Household or other close contacts of active TB cases, regardless of TB skin test status
- No current confirmed or suspected TB
- Not currently receiving or planning to receive anti-HIV therapy in the first 90 days after enrollment. (Note: Participants  can have a past history of ART use, but cannot be on ART and planning to continue.)

How

Participants will be randomized (assigned by chance) to either:

3RPT/INH group: Rifapentine and INH once weekly given for 3 months (under direct observation) versus
9INH group:  INH once daily for 9 months (self-administered)

Those randomized to the 3RPT/INH arm will be seen weekly in the clinic for directly observed therapy.  All participants will be seen monthly while taking study drug and every 3 to 6 months during the 33 month follow-up phase.

What

Rifapentine will be provided by the study.  INH will be obtained by prescription.

Participating ACTG Sites (find contact information) 

This study is open to all U.S. and select non-U.S. ACTG Clinical Research Sites.

 

A5267 A Phase I, Safety, Tolerability, and Pharmacokinetic Interaction Study of Single-Dose TMC207 and Efavirenz in Healthy Volunteers

Enrolling

A5267 is a study designed to measure the amount of two medicines in the blood, TMC207 (a new anti-tuberculosis drug) and Efavirenz, EFV (an approved anti-HIV drug).

Why

- To measure the amount of TMC207 and Efavirenz in the blood
- To find out whether or not the medicines are safe when they are taken together.

Who

- Healthy
- HIV negative
- Adult male and female volunteers, ages 18-65 years
- To be eligible, females cannot be able to have children   
- Agree to follow specific food, drink, and smoking restrictions throughout the study

How

Participants will be admitted to the hospital twice, each time for 3 nights, to measure the amount of drug in the blood over time.  They will return to the clinic several times between these hospital stays to have blood drawn.  Participants will be on the study for a total of 49 days, which includes a one-week safety follow-up visit.
 

What

One oral dose of EFV each evening for 42 days.  Oral dose of TMC207 on Day 1 and on Day 28 during hospital stays.

Participating ACTG Sites (find contact information)
Source: February 4, 2010 DAIDS-ES Protocol Registration Report

• Johns Hopkins Adult AIDS CRS
• Vanderbilt Therapeutics CRS

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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.

A5239: Pioglitazone Prior to HCV Therapy in Nonresponders to Peg/IFN & RBV with Insulin Resistance (PIO PRE-C)  

Enrolling

This study will look at a new strategy for Hepatitis C treatment for people co-infected with HIV and Hepatitis C (HCV). It will look at participants that did not respond to HCV treatment in the past in order to find out if HCV medication will work better if they are first given medication to treat insulin resistance. This medication, called pioglitazone, is commonly used to treat diabetes.  Subjects will receive pioglitazone therapy followed by continued pioglitazone with HCV treatment.

Why

Insulin resistance is common in people with both HIV and hepatitis C and is associated with a poor response to treatment for HCV. Insulin resistance means that the body needs to produce higher than usual amounts of the insulin hormone to keep blood sugar (glucose) within the normal range. The study will also test whether pioglitazone is safe in HIV/HCV infected people.

Who

- HIV-1 and HCV co-infected (HCV genotype 1 only)
- Previously treated for HCV with PEG-interferon and weight-based ribavirin given for more than 12 weeks
- Did not respond to previous HCV treatment
- Currently on stable OR no HIV medication for 12 weeks prior to study entry
- Not on ddI or AZT
- Have insulin resistance based on fasting insulin and glucose tests (assessed for at screening)
- CD4 count greater than 200

How

The study will consist of two Steps:

Step 1: Participants will take pioglitazone for 24 to 28 weeks.

Step 2: Participants will continue to take the same medication as in step 1 (pioglitazone), and will also take medication to treat HCV (PEG-interferon and ribavirin) for an additional 12 to 48 weeks depending on the response to treatment.

What

Pioglitazone, PEG-interferon and ribavirin will be provided by the study.

Participating ACTG Sites (find contact information)
Source: February 4, 2010 DAIDS-ES Protocol Registration Report

• AIDS Community Health Ctr. ACTG CRS
• Cornell CRS
• IHV Baltimore Treatment CRS
• Massachusetts General Hospital ACTG CRS
• MetroHealth CRS
• New Jersey Medical School- Adult Clinical Research
• Northwestern University CRS
• NY Univ. HIV/AIDS CRS
• UCSD, AVRC CRS
• UCSF AIDS CRS
• Univ. of Cincinnati CRS
• Univ. of Rochester ACTG CRS
• University of Colorado Hospital CRS
• Virginia Commonwealth Univ. Medical Ctr. CRS

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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.

A5252: Duloxetine and Methadone for the Treatment of HIV-Associated Painful Peripheral Neuropathy 

A5252 Protocol Team Message to the HIV Community- PDF

Enrolling

This is a study of methadone and duloxetine for people who are HIV-infected and have pain in their feet and/or legs because of neuropathy.

Why

The main purpose of this study is to find out if two different drugs, methadone and duloxetine, reduce neuropathy pain in persons infected with HIV.  This study will also look at whether two drugs are better than one for treating neuropathy pain.

Who

• HIV-1 infected people at least 18 years old
• Ongoing neuropathy pain in feet and/or legs for at least 6 months, in spite of treatment
• On stable anti-HIV medications or not taking anti-HIV medications for 30 days before study entry
• Willing to attend all study visits, complete a daily pain diary as instructed by study staff, and avoid medications that are not allowed by this study

How

Participants will take study treatments: (1) methadone with duloxetine placebo, (2) duloxetine with methadone placebo, (3) methadone and duloxetine, and (4) methadone placebo with duloxetine placebo.  A placebo is like a “sugar pill.” 

Participants will be assigned by chance (like flipping a coin) to the order of study treatments.  This is a crossover study, meaning that participants will get all of the possible study treatments.  Each study treatment period will last four weeks apiece, each followed by one week when the study drugs are gradually decreased and stopped (crossover periods).

The duration of the study is between 21 and 23 weeks.

What

 Methadone, duloxetine, and placebos will be provided by the study.

Participating ACTG Sites (find contact information)
Source: February 4, 2010 DAIDS-ES Protocol Registration Report

• AIDS Community Health Ctr. ACTG CRS
• Harbor-UCLA Med. Ctr. CRS
• Houston AIDS Research Team CRS
• Johns Hopkins Adult AIDS CRS
• Massachusetts General Hospital ACTG CRS
• MetroHealth CRS
• Northwestern University CRS
• NY Univ. HIV/AIDS CRS
• The Ponce de Leon Ctr. CRS
• Univ. of Rochester ACTG CRS
• Washington U CRS

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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.

A5260: Cardiovascular, Anthropometric, and Skeletal Effects of Antiretroviral Therapy (ART) Initiation with Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) plus Atazanavir/Ritonavir (ATV/r), Darunavir/Ritonavir (DRV/r), or Raltegravir (RAL): Metabolic Substudy of A5257

Enrollling

This is an optional substudy of A5257. The substudy will be measuring changes in body fat, bone, blood vessels, blood sugar, cholesterol, and kidney function in participants receiving one of the three treatment regimens given in A5257 as their first anti-HIV regimen.

Why

To learn if there are any cardiovascular, body fat, bone, or other metabolic changes in participants starting the three anti-HIV regimens.

Who
 

• Planning to enroll in two ACTG studies; A5257 and A5001 (ALLRT)
• No diabetes
• No history of some types of heart disease
• No uncontrolled thyroid disease 
• No current use of some medications used to lower cholesterol

How

The study will include blood draws for metabolic evaluations such as cholesterol and blood sugar and other assessments including ultrasounds to measure blood vessel changes (carotid artery intima-media thickness [CIMT] and brachial artery flow-mediated vasodilation [FMD]), body fat and bone DEXA scans, and abdominal CT scans.
There will be no medications provided by A5260s.  Study treatment will be given as part of A5257.
Participants will be in this study about 144 weeks. 

What

Metabolic evaluations will be provided by the study.

Participating ACTG Sites (find contact information)
Source: February 4, 2010 DAIDS-ES Protocol Registration Report

• AIDS Community Health Ctr. ACTG CRS
• Beth Israel Deaconess Med. Ctr., ACTG CRS
• Brigham and Women's Hosp. ACTG CRS
• Case CRS
• Harbor-UCLA Med. Ctr. CRS
• Hosp. of the Univ. of Pennsylvania CRS
• Houston AIDS Research Team CRS
• Johns Hopkins Adult AIDS CRS
• Massachusetts General Hospital ACTG CRS
• MetroHealth CRS
• Moses H. Cone Memorial Hosp. CRS
• New Jersey Medical School- Adult Clinical Research
• Northwestern University CRS
• NY Univ. HIV/AIDS CRS
• Pitt CRS
• Rush Univ. Med. Ctr. ACTG CRS
• The Ohio State Univ. AIDS CRS
• The Ponce de Leon Ctr. CRS
• UCLA CARE Center CRS
• UCSF AIDS CRS
• UNC AIDS CRS
• Univ. of Cincinnati CRS
• Univ. of Rochester ACTG CRS
• University of Colorado Hospital CRS
• University of Washington AIDS CRS
• USC CRS
• Vanderbilt Therapeutics CRS
• Washington U CRS 

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