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Completed Phase 2 Interventional

Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy

ClinicalTrials.gov ID: NCT00000831

Public ClinicalTrials.gov record NCT00000831. 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 Nov 9, 2026, 4:32 PM EST

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Brief summary

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

To elucidate the relationship between virologic risk factors and immunologic and clinical progression in patients receiving monotherapy in protocol ACTG 175, and to compare new treatment regimens with combinations of reverse transcriptase inhibitors in long-term recipients of monotherapy. Specifically, to determine, in patients who have been taking zidovudine (AZT) alone for a long time, whether it is beneficial to add lamivudine (3TC) to AZT or to switch to d4T alone, and also to determine, in patients who have been taking didanosine (ddI) alone for a long time, whether it is beneficial to add AZT or AZT/3TC to ddI. Characteristics of virus replication, pathogenicity, and resistance are thought to determine the durability of virologic and clinical response to nucleoside reverse transcriptase inhibitors. Previous results of ACTG 175 suggest that either a switch to ddI or addition of ddI in patients receiving AZT results in better clinical, virologic, and CD4 cell response compared to continuation of AZT alone.

Study identification

NCT ID
NCT00000831
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
280 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
May 1998 (Actual)
Last update posted
Nov 4, 2021

Ends 1998

United States locations

U.S. sites
38
U.S. states
18
U.S. cities
30
Facility City State ZIP Site status
Alabama Therapeutics CRS Birmingham Alabama — —
USC CRS Los Angeles California 90033 —
UCLA CARE Center CRS Los Angeles California 90095 —
Stanford CRS Palo Alto California 94305 —
Ucsd, Avrc Crs San Diego California 92103 —
Ucsf Aids Crs San Francisco California — —
Santa Clara Valley Med. Ctr. San Jose California — —
San Mateo County AIDS Program San Mateo California — —
Harbor-UCLA Med. Ctr. CRS Torrance California 90502 —
University of Colorado Hospital CRS Aurora Colorado — —
Univ. of Miami AIDS CRS Miami Florida — —
Emory Univ. Hemophilia Program Office Atlanta Georgia 30365 —
Northwestern University CRS Chicago Illinois 60611 —
Cook County Hosp. CORE Ctr. Chicago Illinois 60612 —
Rush Univ. Med. Ctr. ACTG CRS Chicago Illinois 60612 —
Indiana Univ. School of Medicine, Infectious Disease Research Clinic Indianapolis Indiana 46202 —
Tulane Hemophilia Treatment Ctr. New Orleans Louisiana — —
Johns Hopkins Adult AIDS CRS Baltimore Maryland 21287 —
Massachusetts General Hospital ACTG CRS Boston Massachusetts 02114 —
Bmc Actg Crs Boston Massachusetts 02118 —
Beth Israel Deaconess - East Campus A0102 CRS Boston Massachusetts — —
Beth Israel Deaconess Med. Ctr., ACTG CRS Boston Massachusetts — —
University of Minnesota, ACTU Minneapolis Minnesota — —
St. Louis ConnectCare, Infectious Diseases Clinic St Louis Missouri — —
Washington U CRS St Louis Missouri — —
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr. Omaha Nebraska — —
SUNY - Buffalo, Erie County Medical Ctr. Buffalo New York 14215 —
NY Univ. HIV/AIDS CRS New York New York 10016 —
Cornell University A2201 New York New York 10021 —
Univ. of Rochester ACTG CRS Rochester New York 14642 —
Unc Aids Crs Chapel Hill North Carolina 27599 —
Carolinas HealthCare System, Carolinas Med. Ctr. Charlotte North Carolina 28203 —
Regional Center for Infectious Disease, Wendover Medical Center CRS Greensboro North Carolina 27401 —
Univ. of Cincinnati CRS Cincinnati Ohio 45267 —
Case CRS Cleveland Ohio — —
The Ohio State Univ. AIDS CRS Columbus Ohio — —
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 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00000831, 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 Nov 9, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00000831 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →