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NCT00001085 · ClinicalTrials.gov registry record · Phase 2
A Study of 141W94 Used Alone or in Combination With Zidovudine Plus 3TC in HIV-Infected Patients
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 94
- Enrollment target
NCT00001085 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 94 participants.
The verdict
NCT00001085, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 94 participants
- Enrollment target
Study Summary
To determine the proportion of patients whose plasma HIV-1 RNA level remains below a detectable level (less than 500/ml) after 24 weeks of study therapy with either 141W94 monotherapy or 141W94 plus zidovudine (ZDV) and lamivudine (3TC). To determine the safety and tolerability of 141W94 monotherapy and the combination of 141W94 plus 3TC in patients with HIV infection. Although dramatic inhibition of HIV-1 replication is achieved with ritonavir or indinavir monotherapy, in both cases maximum suppression required combination treatment together with nucleoside analog RT inhibitors. This study tests the hypothesis that monotherapy with 141W94 doses that result in Cmin levels far in excess of the IC90 corrected for plasma protein binding for HIV-1 can achieve the same virologic and immunologic effects in terms of magnitude and durability, as has been observed with combinations of other protease inhibitors plus nucleoside analogs.
Interventions
- DRUG Zidovudine
- DRUG Lamivudine
- DRUG Amprenavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Est. Completion | 1998-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001085
The ClinicalTrials.gov registry entry for NCT00001085 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 94 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 3 interventions - of which Zidovudine is the first listed.
NCT00001085 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001085 about?
NCT00001085 is a clinical study titled "A Study of 141W94 Used Alone or in Combination With Zidovudine Plus 3TC in HIV-Infected Patients". To determine the proportion of patients whose plasma HIV-1 RNA level remains below a detectable level (less than 500/ml) after 24 weeks of study therapy with either 141W94 monotherapy or 141W94 plus zidovudine (ZDV) and lamivudine (3TC). To determine the safety and tolerability of 141W94 monotherapy...
What is the current status of trial NCT00001085?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 94 participants. Estimated completion is 1998-09.
What interventions are being tested in trial NCT00001085?
The interventions under investigation include: Zidovudine (DRUG), Lamivudine (DRUG), Amprenavir (DRUG).
Who is sponsoring clinical trial NCT00001085?
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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