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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
NCT00002389 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00002389
The ClinicalTrials.gov registry entry for NCT00002389 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Glaxo Wellcome, which has 18 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00002389 reports 15 study locations spanning 12 distinct geographic areas — top geographies include California, New York, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00002389?
The interventions under investigation include: Zidovudine (DRUG), Lamivudine (DRUG), Abacavir sulfate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00002389?
This trial is sponsored by Glaxo Wellcome, which has 18 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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