Effectiveness of and Immune Response to HIV Vaccination Followed by Treatment Interruption in HIV Infected Patients
Public ClinicalTrials.gov record NCT00080106. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Antiretroviral Effect of Immunization With the MRK Ad5 HIV-1 Gag Vaccine in HIV-1 Infected Individuals Who Interrupt Antiretroviral Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00080106
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 114 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2004 (Type not available)
- Primary completion
- Sep 2007 (Actual)
- Completion
- May 2011 (Actual)
- Last update posted
- Nov 9, 2021
2004 – 2011
United States locations
- U.S. sites
- 27
- U.S. states
- 16
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA CARE Center CRS | Los Angeles | California | 90035 | — |
| Stanford CRS | Palo Alto | California | 94304-5350 | — |
| Univ. of California Davis Med. Ctr., ACTU | Sacramento | California | 95817 | — |
| Ucsd, Avrc Crs | San Diego | California | 92103 | — |
| Ucsf Aids Crs | San Francisco | California | 94110 | — |
| Univ. of Miami AIDS CRS | Miami | Florida | 33136 | — |
| Univ. of Hawaii at Manoa, Leahi Hosp. | Honolulu | Hawaii | 96816 | — |
| Rush Univ. Med. Ctr. ACTG CRS | Chicago | Illinois | 60612 | — |
| Indiana Univ. School of Medicine, Infectious Disease Research Clinic | Indianapolis | Indiana | 46202-5250 | — |
| IHV Baltimore Treatment CRS | Baltimore | Maryland | 21201 | — |
| Massachusetts General Hospital ACTG CRS | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Med. Ctr., ACTG CRS | Boston | Massachusetts | 02215 | — |
| University of Minnesota, ACTU | Minneapolis | Minnesota | 55455 | — |
| Washington U CRS | St Louis | Missouri | 63110 | — |
| Beth Israel Med. Ctr., ACTU | New York | New York | 10003 | — |
| NY Univ. HIV/AIDS CRS | New York | New York | 10016 | — |
| Cornell CRS | New York | New York | 10021 | — |
| AIDS Care CRS | Rochester | New York | 14607 | — |
| Univ. of Rochester ACTG CRS | Rochester | New York | 14642 | — |
| Unc Aids Crs | Chapel Hill | North Carolina | 27514 | — |
| Case CRS | Cleveland | Ohio | 44106 | — |
| MetroHealth CRS | Cleveland | Ohio | 44109 | — |
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | — |
| Pitt CRS | Pittsburgh | Pennsylvania | 15213 | — |
| The Miriam Hosp. ACTG CRS | Providence | Rhode Island | 02906 | — |
| Univ. of Texas Medical Branch, ACTU | Galveston | Texas | — | — |
| University of Washington AIDS CRS | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00080106, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 9, 2021 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00080106 live on ClinicalTrials.gov.