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

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Investigation of V520 in an HIV Vaccine Proof-of-Concept 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

Brief Summary

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.

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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

(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 Measure ^†

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 ]

Condition ^†

AIDS
HIV Infections

Intervention ^†

Biological: Comparator: V520
Drug: Comparator: placebo

MEDLINE PMIDs

Links

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

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

1500

Start Date ^†

November 2004

Completion Date

March 2009

Eligibility Criteria ^†

Inclusion Criteria:

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

Exclusion Criteria: None

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Administrative Information Fields

NCT ID ^†

NCT00095576

Organization ID

2004_091

Secondary IDs ^††

V520-023

Study Sponsor ^†

Merck

Collaborators ^††

HIV Vaccine Trials Network

Investigators ^†

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

December 2008

First Received Date ^†

November 5, 2004

Last Updated Date

December 22, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.