Investigation of V520 in an HIV Vaccine Proof-of-Concept Study - Full Text View

Sponsors and Collaborators:	Merck HIV Vaccine Trials Network
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00095576

Purpose

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.

Condition	Intervention	Phase
AIDS HIV Infections	Biological: Comparator: V520 Drug: Comparator: placebo	Phase II

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Merck:

Primary Outcome Measures:

(1) General safety and tolerability, (2) Acquisition of HIV-1 infection, (3) HIV-1 viral load [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	1500
Study Start Date:	November 2004
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental V520	Biological: Comparator: V520 V520 in three 1 mL IM doses at Day 1, Week 4, and Week 26.
2: Placebo Comparator Placebo	Drug: Comparator: placebo Placebo to V520 in three 1 mL IM doses at Day 1, Week 4, and Week 26.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy, HIV seronegative adults at high risk of acquiring HIV infection
Cannot have previously received an investigational vaccine

Exclusion Criteria: None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00095576

Sponsors and Collaborators

Merck

HIV Vaccine Trials Network

Investigators

Study Director:

Medical Monitor

Merck

More Information

(Click here for more information about this trial) This link exits the ClinicalTrials.gov site

Publications indexed to this study:

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.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2004_091, V520-023
Study First Received:	November 5, 2004
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00095576
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Communicable Diseases
RNA Virus Infections
Slow Virus Diseases

Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 13, 2009