Investigation of V520 in a HIV Vaccine Dose Refinement Study - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00350623

Purpose

This study will test the safety and immunogenicity of an investigational HIV vaccine. Immunogenicity will be measured by evaluating the immune response to several different dose levels.

Condition	Intervention	Phase
HIV Infections	Biological: V520	Phase II

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Merck:

Study Start Date:

October 2006

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Demonstrates good general health
HIV, HBsAg, and HCV seronegative
Low risk of acquiring HIV infection
ALT lab value within normal range

Exclusion Criteria:

Previously received an investigational HIV vaccine
Has a known or suspected impairment of immunologic function
Has a clinically significant chronic medical condition that is considered progressive
Has a major psychiatric illness
Has any history of malignancy, with the exception of basal cell or squamous cell skin cancer
Weighs less than 105 lbs.
Has a recent (within two years) history of chronic alcohol abuse
Has a contraindication to intramuscular (IM) injection, such as anticoagulant therapy or thrombocytopenia
Female is pregnant or breast feeding, or expecting to conceive or donate eggs during the study
Male subject is planning to impregnate or provide sperm donation during the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350623

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Study ID Numbers:	2006_501
Study First Received:	July 7, 2006
Last Updated:	September 25, 2007
ClinicalTrials.gov Identifier:	NCT00350623
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

AIDS

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:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009