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NCT00014014 · ClinicalTrials.gov registry record · Phase 1
Zidovudine and Lamivudine Given Once Versus Twice Daily
A Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 20
- Study locations
NCT00014014: Completed Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00014014 is a Phase 1 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 20 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00014014, a Phase 1 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to see if the full daily dose of Combivir (zidovudine \[ZDV\]/lamivudine \[3TC\]) taken once a day is as effective as the usual recommended twice-a-day dose. Studies have shown that the antiviral activity of ZDV can continue in the body even after there does not appear to be any ZDV left in the blood. This occurs because the body breaks down the drug into substances that remain active against HIV. The body also breaks down 3TC, a drug that is combined with ZDV in the Combivir product, in a similar way. Since antiviral activity may continue after Combivir is removed from the body, it may not be necessary to take the drug as often as once thought. This study carefully measures levels of the active substances in order to find out whether the same amount of antiviral activity occurs with less-frequent dosing.
Conditions Studied
Interventions
- DRUG Lamivudine/Zidovudine
Study Locations (20)
Illinois
- Mt Sinai Hosp Med Ctr / Dept of Pediatrics - Chicago
- Cook County Hosp - Chicago
- Chicago Children's Memorial Hosp - Chicago
New York
- Metropolitan Hosp Ctr - New York
- State Univ of New York at Stony Brook - Stony Brook
- SUNY Health Sciences Ctr at Syracuse / Pediatrics - Syracuse
California
- Los Angeles County - USC Med Ctr - Los Angeles
- Univ of California, San Diego - San Diego
New Jersey
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp - Newark
- St Joseph's Hosp & Med Center - Paterson
Pennsylvania
- Children's Hosp of Philadelphia - Philadelphia
- Temple University School of Medicine - Philadelphia
Florida
- Univ of Florida Health Science Ctr / Pediatrics - Jacksonville
Georgia
- Emory Univ Hosp / Pediatrics - Atlanta
Louisiana
- Tulane Univ / Charity Hosp of New Orleans - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Est. Completion | 2002-08 |
| Phase | Phase 1 |
What the finished NCT00014014 record still lists
NCT00014014 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (96% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which Lamivudine/Zidovudine is the first listed.
NCT00014014 names 20 study sites across 13 states, led by Illinois, New York, California.
Frequently Asked Questions
What is clinical trial NCT00014014 about?
NCT00014014 is a clinical study titled "Zidovudine and Lamivudine Given Once Versus Twice Daily". The purpose of this study is to see if the full daily dose of Combivir (zidovudine \[ZDV\]/lamivudine \[3TC\]) taken once a day is as effective as the usual recommended twice-a-day dose. Studies have shown that the antiviral activity of ZDV can continue in the body even after there does not appear ...
What is the current status of trial NCT00014014?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. Estimated completion is 2002-08.
What conditions does trial NCT00014014 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00014014?
The interventions under investigation include: Lamivudine/Zidovudine (DRUG).
Who is sponsoring clinical trial NCT00014014?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00014014 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
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 NCT00014014's enrollment target sits among peer trials
20 487th of 542 higher than 42 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections 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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