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Completed Phase 2 Interventional

Antiviral Activity of and Resistance to Lamivudine in Combination With Zidovudine, Stavudine, or Didanosine

ClinicalTrials.gov ID: NCT00000838

Public ClinicalTrials.gov record NCT00000838. 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 25, 2026, 6:38 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 II, Randomized Study of the Antiviral Activity and Resistance Interactions of Lamivudine (3TC) in Combination With Zidovudine (AZT), Stavudine (d4T), or Didanosine (ddI) Versus Monotherapy With ddI or d4T in HIV-Infected Individuals With 200 - 600 CD4+ Cells/mm3 and No Previous Nucleoside Experience

Brief summary

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

To evaluate the efficacy, safety, and pharmacokinetics of lamivudine (3TC) combined with zidovudine (AZT), stavudine (d4T), or didanosine (ddI) in comparison with d4T or ddI monotherapy in HIV-infected patients with no prior nucleoside therapy. 3TC may be uniquely effective in combination with AZT due to the interaction of AZT and 3TC resistance mutations. One explanation is that the M184V mutation, which confers resistance to 3TC, suppresses AZT resistance. This benefit of 3TC may not extend to combination therapy with other nucleoside analogs.

Study identification

NCT ID
NCT00000838
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
256 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
Mar 1998 (Actual)
Last update posted
Nov 4, 2021

Ends 1998

United States locations

U.S. sites
31
U.S. states
15
U.S. cities
24
Facility City State ZIP Site status
Alabama Therapeutics CRS Birmingham Alabama — —
UCLA CARE Center CRS Los Angeles California 90095 —
Stanford CRS Palo Alto California 94115 —
Ucsd, Avrc Crs San Diego California 92103 —
Santa Clara Valley Med. Ctr. San Jose California 95128 —
San Mateo County AIDS Program San Mateo California — —
University of Colorado Hospital CRS Aurora Colorado 80262 —
Univ. of Miami AIDS CRS Miami Florida 33136 —
Queens Med. Ctr. Honolulu Hawaii 96816 —
Univ. of Hawaii at Manoa, Leahi Hosp. Honolulu Hawaii 96816 —
Cook County Hosp. CORE Ctr. Chicago Illinois 60612 —
Rush Univ. Med. Ctr. ACTG CRS Chicago Illinois 60612 —
Weiss Memorial Hosp. Chicago Illinois 60640 —
Northwestern University CRS Chicago Illinois — —
Indiana Univ. School of Medicine, Infectious Disease Research Clinic Indianapolis Indiana 46202 —
Methodist Hosp. of Indiana Indianapolis Indiana 46202 —
Johns Hopkins Adult AIDS CRS Baltimore Maryland 21287 —
Beth Israel Deaconess Med. Ctr., ACTG CRS Boston Massachusetts — —
St. Louis ConnectCare, Infectious Diseases Clinic St Louis Missouri 63112 —
Washington U CRS St Louis Missouri — —
SUNY - Buffalo, Erie County Medical Ctr. Buffalo New York 14215 —
Beth Israel Med. Ctr. (Mt. Sinai) New York New York 10003 —
NYU Med. Ctr., Dept. of Medicine New York New York 10016 —
Univ. of Rochester ACTG CRS Rochester New York — —
Unc Aids Crs Chapel Hill North Carolina — —
Carolinas HealthCare System, Carolinas Med. Ctr. Charlotte North Carolina — —
Regional Center for Infectious Disease, Wendover Medical Center CRS Greensboro North Carolina — —
MetroHealth CRS Cleveland Ohio 44109 —
The Ohio State University Medical Center Columbus Ohio 43210 —
Hosp. of the Univ. of Pennsylvania CRS Philadelphia Pennsylvania 19104 —
University of Washington AIDS CRS Seattle Washington 98122 —

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 NCT00000838, 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 Nov 4, 2021 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00000838 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →