| November 5, 2004 |
| October 21, 2009 |
| November 2004 |
| October 2009 (final data collection date for primary outcome measure) |
- (1) General safety and tolerability [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
- Acquisition of HIV-1 infection [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
- HIV-1 viral load [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
|
| proprietary information - exploratory (non-confirmatory) trial |
| Complete list of historical versions of study NCT00095576 on ClinicalTrials.gov Archive Site |
| To demonstrate a favorable effect on disease progression measured by a durable suppression of HIV-1 plasma viral RNA and a lack of decline (preservation) of CD4 cell count [ Time Frame: Throughout study ] [ Designated as safety issue: No ] |
| proprietary information - exploratory (non-confirmatory) trial |
| |
| Investigation of V520 in an HIV Vaccine Proof-of-Concept Study |
| A Multicenter, Double-Blind, Randomized, Placebo-Controlled Phase II Proof-of-Concept Study to Evaluate the Safety and Efficacy of a 3-Dose Regimen of the V520 Vaccine in Adults at High Risk of HIV-1 Infection |
This study will test the safety and efficacy of an investigational HIV vaccine. Efficacy will be measured by either prevention of HIV infection or control of HIV viral load in subjects who become HIV infected. |
No further treatment is being given in V520-023, however patients are being followed. V520-023 protocol will end earlier than originally planned per protocol and participants (HIV infected and uninfected) will have the option of participating in an observational long term follow up protocol called V520-030/HVTN 504, which will serve as an extension of V520-023 and will continue through the end of 2009. |
| Phase II |
| Interventional |
| Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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- Biological: Comparator: V520
- Drug: Comparator: placebo
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- Experimental: V520
- Placebo Comparator: Placebo
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| Buchbinder SP, Mehrotra DV, Duerr A, Fitzgerald DW, Mogg R, Li D, Gilbert PB, Lama JR, Marmor M, Del Rio C, McElrath MJ, Casimiro DR, Gottesdiener KM, Chodakewitz JA, Corey L, Robertson MN; the Step Study Protocol Team. Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial. Lancet. 2008 Nov 29;372(9653):1881-1893. Epub 2008 Nov 13. |
| |
| Active, not recruiting |
| 1500 |
| January 2010 |
| October 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Healthy, HIV seronegative adults at high risk of acquiring HIV infection
- Cannot have previously received an investigational vaccine
Exclusion Criteria: None |
| Both |
| 18 Years to 45 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
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| |
| NCT00095576 |
| Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
| 2004_091, V520-023/V520-030 |
| Merck |
| HIV Vaccine Trials Network |
| Study Director: |
Medical Monitor |
Merck |
|
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| Merck |
| October 2009 |
