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A Multi-Center Clinical Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS Post First Episode PCP

Phase 3
Completed
Conditions
HIV Infections
Registration Number
NCT00000700
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Brief Summary

To examine the dose of zidovudine (AZT) that was used in the first placebo-controlled study of AZT in AIDS patients as well as a lower dose of AZT in order to determine if the lower dose results in less harmful side effects while still being effective. Previous studies have shown the effectiveness of AZT in AIDS therapy. AZT has been effective in test tube studies at varying doses. There is a need to see if lower doses result in effective therapy with less harmful side effects.

Detailed Description

Previous studies have shown the effectiveness of AZT in AIDS therapy. AZT has been effective in test tube studies at varying doses. There is a need to see if lower doses result in effective therapy with less harmful side effects.

Patients are assigned at random to one of two treatment programs: (1) 1 dose of AZT given orally (PO) for 6 doses per day; (2) 2 doses of AZT PO for 4 weeks followed by 1 dose PO for the remainder of the trial.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
482
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (28)

Los Angeles County - USC Med Ctr

🇺🇸

Los Angeles, California, United States

UCLA CARE 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

Univ of Miami School of Medicine

🇺🇸

Miami, Florida, United States

Charity Hosp / Tulane Univ Med School

🇺🇸

New Orleans, Louisiana, 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

Scroll for more (18 remaining)
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States

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