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Completed Phase 3 Interventional

A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past

ClinicalTrials.gov ID: NCT00002320

Public ClinicalTrials.gov record NCT00002320. 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 Sep 5, 2026, 10:13 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 Randomized, Double-Blind Multicenter Trial to Compare the Safety and Efficacy of Lamivudine (3TC; GR109714X) Monotherapy Versus Zidovudine (AZT) Monotherapy Versus 3TC Administered With AZT in the Treatment of HIV-1 Infected Patients Who Are AZT Naive (< 4 Weeks) With CD4 Cell Counts of 200-500 Cells/mm3

Brief summary

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

To evaluate the safety and efficacy of high-dose lamivudine (3TC) alone versus zidovudine (AZT) alone versus 3TC at high and low doses in combination with AZT in HIV-1 infected patients. PER 02/27/95 AMENDMENT: To evaluate the efficacy and safety of both blinded and open-label combination therapy.

Study identification

NCT ID
NCT00002320
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Glaxo Wellcome
Industry
Enrollment
320 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
12 Years and older
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
Not listed
Last update posted
Dec 11, 2005

United States locations

U.S. sites
18
U.S. states
14
U.S. cities
18
Facility City State ZIP Site status
Combat Group Los Angeles California 90028
San Diego Community Research Group San Diego California 92104
Pacific Oaks Med Group Sherman Oaks California 91403
Harbor - UCLA Med Ctr Torrance California 90509
Infectious Disease Research Institute Inc Tampa Florida 33614
AIDS Research Consortium of Atlanta Atlanta Georgia 30308
Chicago Ctr for Clinical Research Chicago Illinois 60607
Louisiana Cardiovascular Research Ctr New Orleans Louisiana 70119
CRI of New England Brookline Massachusetts 02445
Saint Luke's - Roosevelt Hosp Ctr New York New York 10019
Univ of North Carolina School of Medicine Chapel Hill North Carolina 275997215
Med College of Ohio Toledo Ohio 43699
Portland Veterans Adm Med Ctr / Rsch & Education Grp Portland Oregon 97210
Mem Hosp of Rhode Island Pawtucket Rhode Island 02860
Central Texas Med Foundation Austin Texas 78751
Nicholaos Bellos Dallas Texas 75246
Richmond AIDS Consortium Richmond Virginia 23219
Wisconsin Community - Based Research Consortium Milwaukee Wisconsin 53202

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 4 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00002320, 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 Dec 11, 2005 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00002320 live on ClinicalTrials.gov.

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