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NCT01386970 · ClinicalTrials.gov registry record · Phase 4
Effect of Gender and HIV Infection on Zidovudine and Lamivudine Pharmacokinetics
A Phase 4 study of HIV, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 4
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT01386970: Completed Phase 4 study of HIV, sponsored by University of Colorado, Denver.
NCT01386970 is a Phase 4 study of HIV that has completed, run by University of Colorado, Denver. The registered enrollment target is 43 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01386970, a Phase 4 study of HIV, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study Summary
This study evaluated the blood and blood cell concentrations of zidovudine and lamivudine in men versus women and in those with versus without HIV infection. Additionally, markers of side effects were correlated with blood levels of the drugs. The hypothesis was that women and those with HIV would have higher drug levels, as well as markers of side effects.
Primary Outcome
To compare ZDV- triphosphate concentrations in HIV-negative versus HIV-infected subjects.
Conditions Studied
Interventions
- DRUG zidovudine 300mg and lamivudine 150mg as Combivir
Study Locations (1)
Colorado
- University of Colorado Denver and Health Sciences Center - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2005-05 |
| Est. Completion | 2010-07 |
| Phase | Phase 4 |
What the finished NCT01386970 record still lists
NCT01386970 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (90% lower).
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 1 intervention - of which zidovudine 300mg and lamivudine 150mg as Combivir is the first listed.
NCT01386970 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT01386970 about?
NCT01386970 is a clinical study titled "Effect of Gender and HIV Infection on Zidovudine and Lamivudine Pharmacokinetics". This study evaluated the blood and blood cell concentrations of zidovudine and lamivudine in men versus women and in those with versus without HIV infection. Additionally, markers of side effects were correlated with blood levels of the drugs. The hypothesis was that women and those with HIV would h...
What is the current status of trial NCT01386970?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 43 participants. The study started on 2005-05. Estimated completion is 2010-07.
What conditions does trial NCT01386970 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT01386970?
The interventions under investigation include: zidovudine 300mg and lamivudine 150mg as Combivir (DRUG).
Who is sponsoring clinical trial NCT01386970?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01386970 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01386970's enrollment target sits among peer trials
43 239th of 303 higher than 64 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV 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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