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Completed Phase 2 Interventional

Comparison of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (ddC) Versus Ro 31-8959 Plus AZT Plus ddC

ClinicalTrials.gov ID: NCT00001040

Public ClinicalTrials.gov record NCT00001040. 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.

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Official title

Double-Blind, Randomized, Phase II Study of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (Dideoxycytidine; ddC) Versus Ro 31-8959 Plus AZT Plus ddC

Brief summary

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

PRIMARY: To determine the efficacy and toxicity of three treatment regimens: saquinavir mesylate (Ro 31-8959) plus zidovudine (AZT) vs. AZT plus zalcitabine (dideoxycytidine; ddC) vs. Ro 31-8959 plus AZT plus ddC. SECONDARY: To investigate the pharmacokinetics and effects on various clinical parameters of the three regimens.

Study identification

NCT ID
NCT00001040
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
300 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
13 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
May 1994 (Actual)
Completion
Not listed
Last update posted
Mar 1, 2011

United States locations

U.S. sites
10
U.S. states
9
U.S. cities
10
Facility City State ZIP Site status
Univ of Alabama at Birmingham Birmingham Alabama 35294 —
Stanford Univ Med Ctr Stanford California 943055107 —
Univ of Colorado Health Sciences Ctr Denver Colorado 80262 —
Northwestern Univ Med School Chicago Illinois 60611 —
Bellevue Hosp / New York Univ Med Ctr New York New York 10016 —
Univ of Rochester Med Ctr Rochester New York 14642 —
Ohio State Univ Hosp Columbus Ohio 432101228 —
Girard Med Ctr Philadelphia Pennsylvania 191046073 —
Univ TX Galveston Med Branch Galveston Texas 775550882 —
Univ of Washington 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.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00001040, 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 Mar 1, 2011 · Synced Nov 10, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00001040 live on ClinicalTrials.gov.

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