Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Completed Phase 3 Interventional

The Safety and Effectiveness of Zidovudine in the Treatment of Patients With Early AIDS Related Complex

ClinicalTrials.gov ID: NCT00001011

Public ClinicalTrials.gov record NCT00001011. 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 16, 2026, 1:47 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

The Safety and Efficacy of Zidovudine in the Treatment of Patients With Early AIDS Related Complex

Brief summary

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

To determine the safety and usefulness of zidovudine (AZT) for the treatment of patients with early symptomatic HIV infection or early AIDS related complex (ARC). The ability of AZT to suppress HIV, to improve body defenses, and to prevent the occurrence or development of AIDS or advanced ARC is being evaluated. In one human study, patients with AIDS or advanced ARC who received AZT had fewer life-threatening infections, improved in weight and performance, and lived longer than patients who received a placebo (inactive medication). Further studies are needed because toxic effects associated with the use of AZT were noted and the long-term effectiveness and toxicity of AZT are still unknown. It is also unknown if AZT will benefit patients with less severe HIV infections such as early ARC or PGL.

Study identification

NCT ID
NCT00001011
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
538 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
Feb 1995 (Actual)
Last update posted
Nov 4, 2021

Ends 1995

United States locations

U.S. sites
40
U.S. states
15
U.S. cities
30
Facility City State ZIP Site status
Los Angeles County - USC Med Ctr Los Angeles California 90033 —
UCLA CARE Ctr Los Angeles California 90095 —
Palo Alto Veterans Adm Med Ctr / Stanford Univ Palo Alto California 94304 —
Univ of California / San Diego Treatment Ctr San Diego California 921036325 —
Stanford at Kaiser / Kaiser Permanente Med Ctr San Francisco California 94115 —
Stanford Univ School of Medicine Stanford California 94305 —
Harbor UCLA Med Ctr Torrance California 90502 —
George Washington Univ Med Ctr Washington D.C. District of Columbia 20037 —
Univ of Miami School of Medicine Miami Florida 331361013 —
Northwestern Univ Med School Chicago Illinois 60611 —
Indiana Univ Hosp Indianapolis Indiana 462025250 —
Johns Hopkins Hosp Baltimore Maryland 21287 —
Harvard (Massachusetts Gen Hosp) Boston Massachusetts 02114 —
Beth Israel Deaconess - West Campus Boston Massachusetts 02215 —
Univ of Minnesota Minneapolis Minnesota 55455 —
St Louis Regional Hosp / St Louis Regional Med Ctr St Louis Missouri 63112 —
SUNY / Erie County Med Ctr at Buffalo Buffalo New York 14215 —
City Hosp Ctr at Elmhurst / Mount Sinai Hosp Elmhurst New York 11373 —
Beth Israel Med Ctr / Peter Krueger Clinic New York New York 10003 —
Bellevue Hosp / New York Univ Med Ctr New York New York 10016 —
Cornell Univ Med Ctr New York New York 10021 —
Saint Luke's - Roosevelt Hosp Ctr New York New York 10025 —
Mount Sinai Med Ctr New York New York 10029 —
Univ of Rochester Medical Center Rochester New York 14642 —
SUNY - Stony Brook Stony Brook New York 117948153 —
SUNY / State Univ of New York Syracuse New York 13210 —
Bronx Municipal Hosp Ctr/Jacobi Med Ctr The Bronx New York 10461 —
Jack Weiler Hosp / Bronx Municipal Hosp The Bronx New York 10465 —
Montefiore Med Ctr / Bronx Municipal Hosp The Bronx New York 10467 —
Bronx Veterans Administration / Mount Sinai Hosp The Bronx New York 10468 —
Univ of North Carolina Chapel Hill North Carolina 275997215 —
Duke Univ Med Ctr Durham North Carolina 27710 —
Holmes Hosp / Univ of Cincinnati Med Ctr Cincinnati Ohio 452670405 —
Univ Hosp of Cleveland / Case Western Reserve Univ Cleveland Ohio 44106 —
Columbus Children's Hosp Columbus Ohio 432052696 —
Ohio State Univ Hosp Clinic Columbus Ohio 432101228 —
Thomas Jefferson Univ Hosp Philadelphia Pennsylvania 19107 —
Univ of Pittsburgh Med School Pittsburgh Pennsylvania — —
Julio Arroyo West Columbia South Carolina 29169 —
Univ of Washington Seattle Washington 98105 —

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 NCT00001011, 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 16, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00001011 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →