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NCT00002389 · ClinicalTrials.gov registry record · Phase 3
The Safety and Effectiveness of Lamivudine Plus Zidovudine, Used With and Without 1592U89, in HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs
A Phase 3 study of HIV Infections, sponsored by Glaxo Wellcome.
- Completed
- Registry status
- Phase 3
- Development phase
- 210
- Enrollment target
- 15
- Study locations
NCT00002389: Completed Phase 3 study of HIV Infections, sponsored by Glaxo Wellcome.
NCT00002389 is a Phase 3 study of HIV Infections that has completed, run by Glaxo Wellcome. The registered enrollment target is 210 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (53% lower). The trial reports 15 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00002389, a Phase 3 study of HIV Infections, has completed, sponsored by Glaxo Wellcome.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 210 participants
- Enrollment target
- 15
- Study locations
Study Summary
To compare the durability of the viral load response following 48 weeks of treatment with 1592U89/lamivudine (3TC)/zidovudine (ZDV) versus 3TC/ZDV alone. To compare the early antiviral activity following 16 weeks treatment with 1592U89/3TC/ZDV versus 3TC/ZDV alone as demonstrated by the proportion of subjects with viral load \< 400 copies/ml, plasma HIV-1 RNA profiles and CD4+ profiles. To assess the safety and tolerance following 16 and 48 weeks of treatment with 1592U89/3TC/ZDV versus 3TC/ZDV alone.
Conditions Studied
Interventions
- DRUG Zidovudine
- DRUG Lamivudine
- DRUG Abacavir sulfate
Study Locations (15)
California
- East Bay AIDS Ctr - Berkeley
- Kraus Med Partners - Los Angeles
New York
- St Vincent's Hosp and Med Ctr / AIDS Ctr - New York
- Harlem Hosp - New York
Texas
- Dr Nicholaos Bellos - Dallas
- Baylor College of Medicine / Dept of Medicine - Houston
District of Columbia
- Georgetown Univ Med Ctr - Washington D.C.
Florida
- Univ of Miami Dept of Medicine - Miami
Illinois
- Rush Med College / Rush Presbyterian - St Luke's Med Cen - Chicago
Massachusetts
- Boston Med Ctr / Evans - 556 - Boston
New Jersey
- Saint Michael's Med Ctr / Dept of Infectious Diseases - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Phase | Phase 3 |
What the finished NCT00002389 record still lists
NCT00002389 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (53% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which Zidovudine is the first listed.
NCT00002389 lists 15 locations in 12 states (California, New York, Texas).
Frequently Asked Questions
What is clinical trial NCT00002389 about?
NCT00002389 is a clinical study titled "The Safety and Effectiveness of Lamivudine Plus Zidovudine, Used With and Without 1592U89, in HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs". To compare the durability of the viral load response following 48 weeks of treatment with 1592U89/lamivudine (3TC)/zidovudine (ZDV) versus 3TC/ZDV alone. To compare the early antiviral activity following 16 weeks treatment with 1592U89/3TC/ZDV versus 3TC/ZDV alone as demonstrated by the proportion o...
What is the current status of trial NCT00002389?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 210 participants.
What conditions does trial NCT00002389 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00002389?
The interventions under investigation include: Zidovudine (DRUG), Lamivudine (DRUG), Abacavir sulfate (DRUG).
Who is sponsoring clinical trial NCT00002389?
This trial is sponsored by Glaxo Wellcome, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00002389 being conducted?
This trial has 15 study locations across California, District of Columbia, Florida, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00002389's enrollment target sits among peer trials
210 164th of 542 higher than 377 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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