The Safety and Effectiveness of Zidovudine (AZT) in the Treatment of HIV Infection in Patients With AIDS and Advanced ARC

Phase 1

Completed

• Conditions: HIV Infections

• Registration Number: NCT00000999
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

To obtain information about the long-term safety and toxicity of zidovudine (AZT). To ascertain whether interruption/resumption at a lower dosage is the optimal management of AZT toxicity.

Because of the high incidence of toxicity and the relatively short-term follow-up of the patients due to the early ending of the Phase II placebo-controlled experiment, it is valuable to continue to get information on the long-term toxicity of AZT.

Detailed Description

Because of the high incidence of toxicity and the relatively short-term follow-up of the patients due to the early ending of the Phase II placebo-controlled experiment, it is valuable to continue to get information on the long-term toxicity of AZT.

This study provides AZT for 6 months to AIDS patients who were previously enrolled in the AZT Treatment IND protocol and to patients who qualify for AZT under the drug labeling. Patients are randomized to 1 of 2 regimens for management of toxicity.

Study Timeline

• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (23)

LaJolla Veterans Administration Med Ctr; 🇺🇸 La Jolla, California, United States

Los Angeles County - USC Med Ctr; 🇺🇸 Los Angeles, California, United States

Univ of California / San Diego Treatment Ctr; 🇺🇸 San Diego, California, United States

San Francisco AIDS Clinic / San Francisco Gen Hosp; 🇺🇸 San Francisco, California, United States

Stanford at Kaiser / Kaiser Permanente Med Ctr; 🇺🇸 San Francisco, California, United States

Stanford Univ School of Medicine; 🇺🇸 Stanford, California, United States

Louisiana State Univ Med Ctr / Tulane Med School; 🇺🇸 New Orleans, Louisiana, United States

Tulane Univ School of Medicine; 🇺🇸 New Orleans, Louisiana, United States

Johns Hopkins Hosp; 🇺🇸 Baltimore, Maryland, United States

Beth Israel Deaconess - West Campus; 🇺🇸 Boston, Massachusetts, United States

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