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NCT00000838 · ClinicalTrials.gov registry record · Phase 2
Antiviral Activity of and Resistance to Lamivudine in Combination With Zidovudine, Stavudine, or Didanosine
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 256
- Enrollment target
NCT00000838: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000838 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 256 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000838, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 256 participants
- Enrollment target
Study Summary
To evaluate the efficacy, safety, and pharmacokinetics of lamivudine (3TC) combined with zidovudine (AZT), stavudine (d4T), or didanosine (ddI) in comparison with d4T or ddI monotherapy in HIV-infected patients with no prior nucleoside therapy. 3TC may be uniquely effective in combination with AZT due to the interaction of AZT and 3TC resistance mutations. One explanation is that the M184V mutation, which confers resistance to 3TC, suppresses AZT resistance. This benefit of 3TC may not extend to combination therapy with other nucleoside analogs.
Interventions
- DRUG Zidovudine
- DRUG Lamivudine
- DRUG Stavudine
- DRUG Didanosine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Est. Completion | 1998-03 |
| Phase | Phase 2 |
What the finished NCT00000838 record still lists
NCT00000838 is an interventional study that assigns participants to a tested intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% higher).
The record links to 0 conditions, and to 4 interventions - of which Zidovudine is the first listed.
NCT00000838 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00000838 about?
NCT00000838 is a clinical study titled "Antiviral Activity of and Resistance to Lamivudine in Combination With Zidovudine, Stavudine, or Didanosine". To evaluate the efficacy, safety, and pharmacokinetics of lamivudine (3TC) combined with zidovudine (AZT), stavudine (d4T), or didanosine (ddI) in comparison with d4T or ddI monotherapy in HIV-infected patients with no prior nucleoside therapy. 3TC may be uniquely effective in combination with AZT ...
What is the current status of trial NCT00000838?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 256 participants. Estimated completion is 1998-03.
What interventions are being tested in trial NCT00000838?
The interventions under investigation include: Zidovudine (DRUG), Lamivudine (DRUG), Stavudine (DRUG), Didanosine (DRUG).
Who is sponsoring clinical trial NCT00000838?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00000838's enrollment target sits among peer trials
256 215th of 2000 higher than 1,783 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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