Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00001085 record still lists
NCT00001085 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower).
The record links to 0 conditions, and to 3 interventions - of which Zidovudine is the first listed.
NCT00001085 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00001085's enrollment target sits among peer trials
94 764th of 2000 higher than 1,235 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03747146 · 94 participants · NA
Enhanced Recovery After Surgery (ERAS) Total Knee Replacement (TKR) With a Transitional Pain Service
- NCT04061421 · 94 participants · Phase 1
Active Myeloid Target Compound Combinations in MDS/MPN Overlap Syndromes Overlap Syndromes (ABNL-MARRO)
- NCT04205968 · 94 participants · Phase 2
Ramucirumab and Paclitaxel or FOLFIRI in Advanced Small Bowel Cancers
- NCT04464759 · 94 participants · Phase 1
A Study of Nivolumab and Hydroxychloroquine or Nivolumab/Ipilimumab and Hydroxychloroquine in Advanced Melanoma