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Completed Phase 1 Interventional

Zidovudine and Lamivudine Given Once Versus Twice Daily

ClinicalTrials.gov ID: NCT00014014

Public ClinicalTrials.gov record NCT00014014. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 10:19 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase I Pharmacokinetic Study of Once Versus Twice Daily Dosing With Zidovudine and Lamivudine

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00014014
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
20 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
12 Years to 24 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Not listed
Primary completion
Not listed
Completion
Aug 2002 (Actual)
Last update posted
Oct 7, 2013

Ends 2002

United States locations

U.S. sites
19
U.S. states
12
U.S. cities
16
Facility City State ZIP Site status
Los Angeles County - USC Med Ctr Los Angeles California 90033 —
Univ of California, San Diego San Diego California 92103 —
Univ of Florida Health Science Ctr / Pediatrics Jacksonville Florida 32209 —
Emory Univ Hosp / Pediatrics Atlanta Georgia 30306 —
Mt Sinai Hosp Med Ctr / Dept of Pediatrics Chicago Illinois 60608 —
Cook County Hosp Chicago Illinois 60612 —
Chicago Children's Memorial Hosp Chicago Illinois 606143394 —
Tulane Univ / Charity Hosp of New Orleans New Orleans Louisiana 701122699 —
Children's Hosp of Boston Boston Massachusetts 021155724 —
Univ of Mississippi Med Ctr Jackson Mississippi 39213 —
Univ of Medicine & Dentistry of New Jersey / Univ Hosp Newark New Jersey 071032714 —
St Joseph's Hosp & Med Center Paterson New Jersey 07503 —
Metropolitan Hosp Ctr New York New York 10029 —
State Univ of New York at Stony Brook Stony Brook New York 117948111 —
SUNY Health Sciences Ctr at Syracuse / Pediatrics Syracuse New York 13210 —
Children's Hosp of Philadelphia Philadelphia Pennsylvania 191044318 —
Temple University School of Medicine Philadelphia Pennsylvania 19140 —
Saint Jude Children's Research Hosp of Memphis Memphis Tennessee 381052794 —
Texas Children's Hosp / Baylor Univ Houston Texas 77030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00014014, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 7, 2013 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00014014 live on ClinicalTrials.gov.

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