Status:
TERMINATED
Investigation of V520 in an HIV Vaccine Proof-of-Concept Study (V520-023)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
HIV Vaccine Trials Network
Conditions:
AIDS
HIV Infections
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief Summary
This study will test the safety and efficacy of an investigational Human Immunodeficiency Virus (HIV) vaccine. Efficacy will be measured by either prevention of HIV infection or control of HIV viral l...
Detailed Description
No further treatment was given in V520-023, however participants were followed. V520-023 protocol ended earlier than originally planned per protocol and participants (HIV infected and uninfected) had ...
Eligibility Criteria
Inclusion
- Healthy, HIV seronegative adults at high risk of acquiring HIV infection
- Cannot have previously received an investigational vaccine
Exclusion
- In a monogamous relationship with an HIV-1 seronegative partner for \> 1 year
- History of anaphylaxis and/or allergy to vaccine components, including Tris buffer, MgCl2, and polysorbate 80 (TWEEN)
- Received an immune globulin or blood derived products 3 months before injection with the first dose of vaccine/placebo or scheduled within 14 days after injection
- Previously vaccinated with a live virus vaccine within 30 days before injection with the first dose of vaccine or scheduled within 14 days after injection
- Previously vaccinated with an inactivated vaccine within 5 days before injection with the first dose of vaccine or scheduled within 14 days after injection
- Known history of immunodeficiency
- History of malignancy (with some exceptions)
- Contraindication to intramuscular (IM) injection such as anticoagulant therapy or thrombocytopenia
- Female subject who is pregnant or breast feeding, or expecting to conceive or donate eggs through Week 30 of the study
- Male subject who is planning to impregnate or provide sperm donation through Week 30 of the study
- Previously received an investigational HIV vaccine
- Has active drug or alcohol abuse or dependence that would interfere with adherence to study requirements, or endanger the subject's health while on the study
- Has a condition that might endanger the subject's health or interfere with the evaluation of the study objectives
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT00095576
Start Date
November 1 2004
End Date
September 1 2009
Last Update
October 6 2015
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