Safety and Effectiveness of Treating HIV-Positive Patients With an HIV Vaccine (Remune)
A Pilot, Phase II, Double-Blind Study to Assess the Virologic Effect of Remune Versus Incomplete Freund's Adjuvant (IFA) in Patients Who Are Infected With Human Immunodeficiency Virus Type I (HIV-1), Have a Plasma HIV-1 RNA Level Less Than 50 Copies/Ml, Are Receiving Highly Active Antiretroviral Therapy (HAART), and Who Subsequently Discontinue Their HAART Regimen
2 other identifiers
interventional
40
1 country
1
Brief Summary
The purpose of this study is to see if giving HIV-positive patients an HIV vaccine plus anti-HIV drugs can help lower HIV levels in the blood (viral load).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
March 1, 2001
March 21, 2000
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Are receiving an anti-HIV drug combination that contains three drugs from at least two classes of anti-HIV drugs (such as protease inhibitors). Patients must have been receiving this drug combination for at least 6 months before study entry. Before beginning this drug combination, patients must have taken either no anti-HIV drugs or only one or two nucleoside analogues (NRTIs).
- Had a viral load between 5,000 and 100,000 copies/ml before beginning their current anti-HIV therapy.
- Have a viral load below 50 copies/ml while on their current anti-HIV therapy within 2 weeks before study entry.
- Have a CD4 count greater than 350 cells/mm3 at the time of study entry.
- Are at least 13 years old (consent of parent or guardian required if under 18).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Agouron Pharmaceuticals Inc
San Diego, California, 92121, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 21, 2000
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 2001-03