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NCT00117429 · ClinicalTrials.gov registry record · Phase 1
Study of the HIV gp120/NefTat/AS02A Vaccine to Treat Individuals With Chronic HIV-1 Infection on Highly Active Antiretroviral Therapy (HAART)
A Phase 1 study of HIV Infections, sponsored by Marcus Altfeld, M.D., Ph.D..
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT00117429: Completed Phase 1 study of HIV Infections, sponsored by Marcus Altfeld, M.D., Ph.D..
NCT00117429 is a Phase 1 study of HIV Infections that has completed, run by Marcus Altfeld, M.D., Ph.D.. The registered enrollment target is 20 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00117429, a Phase 1 study of HIV Infections, has completed, sponsored by Marcus Altfeld, M.D., Ph.D..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will test the safety and immunogenicity of the gp120/NefTat/AS02A vaccine candidate in individuals with chronic HIV-1 infection successfully treated with HAART. The rationale for this study is based on previous scientific experiments, including data indicating that this vaccine can elicit strong HIV-1-specific T cell immune responses in humans and monkeys and lead to a retardation of HIV-1 disease progression in animal models of HIV-1 infection. The HIV vaccine to be administered during this study consists of three recombinant HIV clade B viral antigens: the envelope glycoprotein gp120 and two regulatory proteins, Nef and Tat.The antigens are formulated in a proprietary adjuvant, AS02A, comprised of two immunostimulants in an oil-in-water emulsion (gp120/NefTat/AS02A). The vaccine and the adjuvant are manufactured and provided for the study by GlaxoSmithKline Biologicals, Rixensart, Belgium. The drugs will be given by intramuscular (IM) injection at a standard dose of 20 mg together with 0.5 ml of the AS02A adjuvant. Twenty HIV-1 infected individuals will be randomly enrolled into three different study groups, receiving either the gp120/NefTat/AS02A vaccine (10 individuals), the AS02A adjuvant alone (5 individuals) or a placebo (5 individuals). After obtaining informed consent, subjects will have a history and physical exam performed and have laboratory tests to confirm they meet all inclusion and exclusion entry criteria. Women of childbearing potential will have a pregnancy test prior to each injection of the investigational product. Injections with vaccine, adjuvant alone, or placebo will then be performed at weeks 0, 4, and 12. Study participants will undergo close monitoring after each vaccination. Blood samples will be obtained for immunological assays at study baseline (2 times) and weeks 2, 4, 6, 12, 14, 24, and 48. All patients will maintain their antiretroviral treatment regimen during the entire study period.
Conditions Studied
Interventions
- BIOLOGICAL HIV gp120/NefTat/AS02A Vaccine
Study Locations (1)
Massachusetts
- Massacusetts General Hospital -Infectious Disease Unit - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2005-06 |
| Est. Completion | 2010-01 |
| Phase | Phase 1 |
What the finished NCT00117429 record still lists
NCT00117429 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (96% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which HIV gp120/NefTat/AS02A Vaccine is the first listed.
NCT00117429 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00117429 about?
NCT00117429 is a clinical study titled "Study of the HIV gp120/NefTat/AS02A Vaccine to Treat Individuals With Chronic HIV-1 Infection on Highly Active Antiretroviral Therapy (HAART)". This study will test the safety and immunogenicity of the gp120/NefTat/AS02A vaccine candidate in individuals with chronic HIV-1 infection successfully treated with HAART. The rationale for this study is based on previous scientific experiments, including data indicating that this vaccine can elicit...
What is the current status of trial NCT00117429?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2005-06. Estimated completion is 2010-01.
What conditions does trial NCT00117429 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00117429?
The interventions under investigation include: HIV gp120/NefTat/AS02A Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00117429?
This trial is sponsored by Marcus Altfeld, M.D., Ph.D., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00117429 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00117429's enrollment target sits among peer trials
20 487th of 542 higher than 42 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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