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NCT00121979 · ClinicalTrials.gov registry record · Phase 2
Study Comparing Racivir and Lamivudine in Treatment-Experienced HIV Subjects
A Phase 2 study of HIV Infections, sponsored by Pharmasset.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 6
- Study locations
NCT00121979: Completed Phase 2 study of HIV Infections, sponsored by Pharmasset.
NCT00121979 is a Phase 2 study of HIV Infections that has completed, run by Pharmasset. The registered enrollment target is 60 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (87% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00121979, a Phase 2 study of HIV Infections, has completed, sponsored by Pharmasset.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 6
- Study locations
Study Summary
Racivir ® (RCV) is an experimental drug which means it is not approved for use by the United States Food and Drug Administration (FDA), but it can be used in research studies like this one. RCV (Racivir®) is part of a class of drugs known as "Nucleoside Reverse Transcriptase Inhibitors" (NRTIs), which are intended to block a further increase in the amount of HIV virus in the body. Laboratory research suggests that RCV (Racivir®) may be effective in patients who have developed resistance to other NRTIs, particularly 3TC (lamivudine, Epivir®). However, a study of RCV (Racivir®) has not been done with patients who have previously been treated with other HAART (Highly Active Antiretroviral Therapy -- taking multiple HIV drugs at once) medications including 3TC (lamivudine, Epivir®). The purpose of this study is to evaluate the safety and effectiveness of RCV (Racivir®) when used together with other HIV drugs in people who have previously been treated with 3TC (lamivudine, Epivir®) and are failing with their current HAART treatments. This study will include a total of 60 HIV infected, HAART-experienced subjects currently receiving 3TC (lamivudine, Epivir®) as part of their HAART therapy. The study will take place at approximately 11 study sites in the US and Latin America.
Conditions Studied
Interventions
- DRUG Racivir, a non-nucleoside reverse transcriptase inhibitor
Study Locations (6)
Other
- Fundacion Huesped Clinical Research - Buenos Aires
- Instituto Nacional de Nutricion - Mexico City
- Medical Research Center Consultorio Royal Center - Republico de Panama
Illinois
- Northwestern University - Chicago
New York
- Jacobi Medical Center - The Bronx
South Carolina
- Burnside Clinic - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2004-09 |
| Est. Completion | 2006-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00121979
The ClinicalTrials.gov registry entry for NCT00121979 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (87% lower). The listed sponsor is Pharmasset, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which Racivir, a non-nucleoside reverse transcriptase inhibitor is the first listed.
NCT00121979 reports 6 study locations spanning 4 distinct geographic areas - top geographies include Other, Illinois, New York.
Frequently Asked Questions
What is clinical trial NCT00121979 about?
NCT00121979 is a clinical study titled "Study Comparing Racivir and Lamivudine in Treatment-Experienced HIV Subjects". Racivir ® (RCV) is an experimental drug which means it is not approved for use by the United States Food and Drug Administration (FDA), but it can be used in research studies like this one. RCV (Racivir®) is part of a class of drugs known as "Nucleoside Reverse Transcriptase Inhibitors" (NRTIs), whi...
What is the current status of trial NCT00121979?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2004-09. Estimated completion is 2006-03.
What conditions does trial NCT00121979 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00121979?
The interventions under investigation include: Racivir, a non-nucleoside reverse transcriptase inhibitor (DRUG).
Who is sponsoring clinical trial NCT00121979?
This trial is sponsored by Pharmasset, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00121979 being conducted?
This trial has 6 study locations across Illinois, New York, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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