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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000838
The ClinicalTrials.gov registry entry for NCT00000838 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 256 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Zidovudine is the first listed.
NCT00000838 reports 0 study locations.
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.
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