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Bringing Together Care and Research for Better, Safer, and More Effective Treatments
HIV research studies are essential to provide critical information to help people live longer, healthier, and more comfortable lives.
Our mission has been to develop and provide the highest-quality treatment and care for people living with HIV through research.
We are part of the AIDS Clinical Trials Group (ACTG) of the National Institutes of Health (NIH). The ACTG, the largest HIV clinical-trials organization, plays a major role in defining the standards of care for treatment of HIV infection and opportunistic diseases related to HIV/AIDS around the world.
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Treatment Experienced
Hepatitis
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?
| Study Number | A5212 |
|---|---|
| Study Name | A Double Blind Phase II Study of Multiple Doses of Palifermin (rHuKGF) for the Treatment of Inadequate CD4+ Lymphocyte Recovery in Subjects on Potent Antiretroviral Therapy |
| Description | This study will evaluate whether palifermin (recombinant human keratinocyte growth factor [rHuKGF]) can increase CD4+ lymphocyte counts by stimulating the thymus in HIV-1 infected adults with suppressed viral loads on potent antiretroviral therapy, but inadequate CD4+ recovery. Subjects will be randomized to one of four treatment arms to receive either placebo or one of three dose levels of palifermin intravenously (IV) daily for 3 days. Subjects will be followed on study for a total of 24 weeks.
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| Who Is Eligible | HIV-1 infected men and women ages 18 and older, on potent antiretroviral therapy with plasma HIV-1 RNA ≤200 copies/mm3 for at least 6 months and CD4+ lymphocyte counts ≤250cells/mm3 |
| For More Information | Call (212) 305-7897 or e-mail |
| Study Number | A5240 |
|---|---|
| Study Name | A Phase II Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Human Papillomavirus Vaccine in HIV–1 infected Females. |
| Description | This study will assess the immunogenicity, safety, and tolerability of the quadrivalent human papillomavirus (HPV) recombinant vaccine (GARDASIL) directed against types 6, 11, 16, 18. All participants will be vaccinated by intramuscular injection at day 0 and weeks 8 and 24, and followed for a total of 72 weeks. |
| Who Is Eligible |
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| For More Information | Call (212) 305-7897 or e-mail |
| Study Number | A5241 |
|---|---|
| Study Name | The 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 |
| Description | This is a strategy study for triple-class antiretroviral-experienced or resistant HIV-1 infected subjects that will evaluate the benefit of adding nucleoside reverse transcriptase inhibitors (NRTIs) to a new antiretroviral regimen. A continuous phenotype susceptibility score (cPSS) will be calculated based upon a real-time HIV-1 phenotype/genotype and co-receptor tropism assays to help in selecting a potent salvage regimen. Subjects for whom a study regimen with a cPSS>2.0 can be identified will be randomized to receive a new regimen with or without NRTIs. The study team will recommend options for a new regimen, which may include raltegravir, maraviroc, enfuvirtide, darunavir, tipranavir, or etravirine. The site investigator and subject will choose from the recommended options. |
| Who Is Eligible |
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| For More Information | Call (212) 305-7897 or e-mail |
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.
| Study Number | A5232 |
|---|---|
| Study Name | Optimizing Vaccine Responsiveness in HIV-1 and HCV Infections by Identifying Determinants of Responsiveness: A Pilot Study |
| Description | This is a study to evaluate the immune deficiencies in HIV-1 infected, HCV infected, and HIV/HCV co-infected individuals and determine whether these defects predict response to vaccinations: hepatitis A/hepatitis B immunization and diphtheria/tetatnus toxoid immunization |
| Who Is Eligible |
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| For More Information | Call (212) 305-7897 or e-mail |





