Studies for people who have never taken medicines to treat HIV
ACTG 5257:
This 2 year study is for people who are HIV infected but have never taken HIV medications. The study will also look at how easy the medications are to take and their side effects. The medications used in this study are: Atazanavir (Reyataz®), Ritonavir (Norvir®), emtricitabine/tenofovir (Truvada®), raltegravir (Isentress®), and darunavir (Prezista®). To be eligible for this study, you must have never taken anti-HIV medications, be at least 18 years of age, and have a HIV viral load >1,000 copies m/L. All study medications are provided with the exception of ritonavir which must be obtained through a prescription.
Studies for people who need a new HIV treatment
ACTG 5241:
This 96-week study will look at whether newer anti-HIV drugs are safe and effective in people whose current HIV medicines are not working. The study will also test whether using a specific type of medicines called nucleoside reverse transcriptase inhibitors (NRTIs) are needed to treat HIV in persons failing their current medicines. Finally this study will test whether a medicine resistance test score called the cPSS is able to predict which drugs will work best in people whose virus is resistant to specific HIV medications. To enter the study, you must have HIV viral load greater than 1000, currently on an HIV drug regimen that includes a protease inhibitor, have resistance to multiple types of HIV medications. All study medications except NRTIs and ritonavir are provided.
Vaccine Studies:
ACTG 5240:
This study will see if Human Papillomavirus Vaccine (HPV) vaccine, when given in 3 separate doses, is safe and tolerable in women infected with HIV. The study will also check if the HPV vaccine can help the body make substances in response to the vaccination to help fight off disease caused by HPV. This study is the first of its kind to test the HPV vaccine in women infected with HIV and participants will be in this study for about a year and a half and the HPV vaccine is provided. No cervical cancer, very abnormal Pap smear, or genital warts within 180 days as well as no prior vaccinations for HPV.
ACTG 5247:
This 6 month study will determine how well the ZOSTAVAX® is tolerated by HIV-1-infected adults with healthy immune systems who are on antiretroviral therapy and also to determine how effective the vaccine is in the development of protection against reactivation of the varicella virus (the virus that causes chicken pox or shingles). To enter this study, you must have a CD4 cell count >200, be taking anti-HIV medications from 3 classes, not have had shingles in the past year, and have not ever received the varicella/zoster vaccine. You will receive a study provided vaccine or placebo (inactive solution) injection at study entry and at week 6.
Observational Studies:
ACTG 5128:
Participants of this study must be a current or past participant in an ACTG study and agree to have a one-time blood draw. Volunteers will consent to use the new DNA sample for unspecified genetic testing.
