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NCT00000831 · ClinicalTrials.gov registry record · Phase 2
Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 280
- Enrollment target
NCT00000831: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000831 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 280 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (111% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000831, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 280 participants
- Enrollment target
Study Summary
To elucidate the relationship between virologic risk factors and immunologic and clinical progression in patients receiving monotherapy in protocol ACTG 175, and to compare new treatment regimens with combinations of reverse transcriptase inhibitors in long-term recipients of monotherapy. Specifically, to determine, in patients who have been taking zidovudine (AZT) alone for a long time, whether it is beneficial to add lamivudine (3TC) to AZT or to switch to d4T alone, and also to determine, in patients who have been taking didanosine (ddI) alone for a long time, whether it is beneficial to add AZT or AZT/3TC to ddI. Characteristics of virus replication, pathogenicity, and resistance are thought to determine the durability of virologic and clinical response to nucleoside reverse transcriptase inhibitors. Previous results of ACTG 175 suggest that either a switch to ddI or addition of ddI in patients receiving AZT results in better clinical, virologic, and CD4 cell response compared to continuation of AZT alone.
Interventions
- DRUG Zidovudine
- DRUG Lamivudine
- DRUG Stavudine
- DRUG Didanosine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Est. Completion | 1998-05 |
| Phase | Phase 2 |
What the finished NCT00000831 record still lists
NCT00000831 is an interventional study that assigns participants to a tested intervention. The registered 280 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 (111% higher).
The record links to 0 conditions, and to 4 interventions - of which Zidovudine is the first listed.
NCT00000831 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00000831 about?
NCT00000831 is a clinical study titled "Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy". To elucidate the relationship between virologic risk factors and immunologic and clinical progression in patients receiving monotherapy in protocol ACTG 175, and to compare new treatment regimens with combinations of reverse transcriptase inhibitors in long-term recipients of monotherapy. Specifical...
What is the current status of trial NCT00000831?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 280 participants. Estimated completion is 1998-05.
What interventions are being tested in trial NCT00000831?
The interventions under investigation include: Zidovudine (DRUG), Lamivudine (DRUG), Stavudine (DRUG), Didanosine (DRUG).
Who is sponsoring clinical trial NCT00000831?
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 NCT00000831's enrollment target sits among peer trials
280 196th of 2000 higher than 1,800 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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