Effectiveness of and Immune Response to HIV Vaccination Followed by Treatment Interruption in HIV Infected Patients
- Conditions
- HIV Infections
- Interventions
- Biological: MRK Ad5 HIV-1 gag vaccineOther: Vaccine placebo
- Registration Number
- NCT00080106
- Brief Summary
HIV vaccines may help the immune systems of HIV infected patients better control the virus. The goal of this study is to determine whether patients on anti-HIV medications can stop taking those medications if they receive an HIV vaccine. While taking anti-HIV medications, participants will receive either an HIV vaccine or a placebo. Participants will then stop taking their anti-HIV medications and the study will compare the viral loads of participants who received the vaccine with the viral loads of participants who received the placebo.
Primary study hypotheses: 1)The Week 12 and Week 16 post-ART interruption geometric mean HIV-1 RNA levels will be lower among participants who had received MRK Ad5 vaccine prior to ART interruption than among participants who received placebo; 2) the time averaged area under the curve of the log10 HIV-1 RNA copies/ml versus day function in the 16 week post-ART interruption step will be lower among participants who received the MRK Ad5 vaccine prior to ART interruption than among participants who receive placebo.
- Detailed Description
Antiretroviral therapy (ART) has a significant impact on HIV disease; however, HIV cannot be cured with current drug regimens. While the majority of patients initially benefit from ART, drug regimens subsequently fail for many patients due to drug resistance, poor adherence, or toxicity. If given while HIV replication is kept in check by ART, an HIV vaccine may be able to generate an effective long-term immune response capable of controlling the virus, even if ART is discontinued.
The MRK Ad5 HIV-1 gag vaccine uses a replication-defective adenovirus vector and has been found safe in clinical trials of both HIV infected and HIV uninfected adults. This study will evaluate the ability of immunization with the MRK Ad5 HIV-1 gag vaccine to control HIV replication in individuals undergoing treatment interruption. The study will enroll individuals whose HIV replication has been successfully suppressed with ART for at least 2 years.
Participants in this study will be randomly assigned to receive either vaccine or placebo. Both vaccine and placebo will be injected into the upper arm muscle. Participants will take their antiretroviral medications during the first 3 months of the study. Injections will be given on Day 1, Week 4, and Week 26. A study nurse will call participants 1 or 2 days after each injection and participants will be asked to fill out a card with any reactions they have to the injections. About 3 months after the third injection, participants will stop taking their antiretroviral medications for 4 months. Participants will have study visits every 2 to 3 weeks while off medication. After 4 months, participants will have the option of restarting antiretroviral medications or continuing without medication. Participants will then have study visits every 2 months for 8 months. Study visits will include physical exams and blood collection.
All participants will continue to see their primary care provider for HIV treatment and will be restarted on antiretroviral medications if clinically indicated. Participants or their primary care provider will be contacted by phone for updates every 6 months for an additional 3.5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 MRK Ad5 HIV-1 gag vaccine Participants in the experimental arm will receive the MRK Ad5 HIV-1 gag vaccine on Day 1, Week 4 and Week 26. Participants will take their antiretroviral medications during the first 3 months of the study. 2 Vaccine placebo Participants in Arm 2 will receive a placebo vaccine on Day 1, Week 4 and Week 26. Participants will take their antiretroviral medications during the first 3 months of the study.
- Primary Outcome Measures
Name Time Method Analytical treatment interruption (ATI) HIV-1 RNA set-point Throughout study ATI log10 HIV-1 RNA copies/ml at all scheduled evaluations during Step II (ATI) Throughout Step 2
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
Puerto Rico-AIDS CRS
🇵🇷San Juan, Puerto Rico
Massachusetts General Hospital ACTG CRS
🇺🇸Boston, Massachusetts, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
🇺🇸Indianapolis, Indiana, United States
Univ. of California Davis Med. Ctr., ACTU
🇺🇸Sacramento, California, United States
Univ. of Miami AIDS CRS
🇺🇸Miami, Florida, United States
Ucsd, Avrc Crs
🇺🇸San Diego, California, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
🇺🇸Boston, Massachusetts, United States
NY Univ. HIV/AIDS CRS
🇺🇸New York, New York, United States
Ucsf Aids Crs
🇺🇸San Francisco, California, United States
Univ. of Rochester ACTG CRS
🇺🇸Rochester, New York, United States
UCLA CARE Center CRS
🇺🇸Los Angeles, California, United States
Rush Univ. Med. Ctr. ACTG CRS
🇺🇸Chicago, Illinois, United States
IHV Baltimore Treatment CRS
🇺🇸Baltimore, Maryland, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Stanford CRS
🇺🇸Palo Alto, California, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
🇺🇸Honolulu, Hawaii, United States
Beth Israel Med. Ctr., ACTU
🇺🇸New York, New York, United States
AIDS Care CRS
🇺🇸Rochester, New York, United States
Unc Aids Crs
🇺🇸Chapel Hill, North Carolina, United States
MetroHealth CRS
🇺🇸Cleveland, Ohio, United States
Case CRS
🇺🇸Cleveland, Ohio, United States
Pitt CRS
🇺🇸Pittsburgh, Pennsylvania, United States
The Miriam Hosp. ACTG CRS
🇺🇸Providence, Rhode Island, United States
Univ. of Texas Medical Branch, ACTU
🇺🇸Galveston, Texas, United States
University of Washington AIDS CRS
🇺🇸Seattle, Washington, United States
Washington U CRS
🇺🇸Saint Louis, Missouri, United States
Cornell CRS
🇺🇸New York, New York, United States
University of Minnesota, ACTU
🇺🇸Minneapolis, Minnesota, United States