Safety and Efficacy of Zidovudine for Asymptomatic HIV-Infected Individuals
- Conditions
- HIV Infections
- Registration Number
- NCT00000736
- Brief Summary
To determine if treatment with zidovudine (AZT) will delay or prevent the onset of AIDS or AIDS related complex (ARC) in individuals infected with HIV but who do not have symptoms of AIDS or ARC. Also, to compare the dose of AZT found to be useful in AIDS and severe ARC with a lower dose to see if side effects can be reduced.
Results from several studies show that a high percentage of people infected with HIV will eventually develop AIDS or ARC unless an effective treatment is found. Because AZT is known to prolong survival in patients with AIDS or severe ARC and has acceptable toxicity in advanced disease, it is reasonable to try it in less advanced cases.
- Detailed Description
Results from several studies show that a high percentage of people infected with HIV will eventually develop AIDS or ARC unless an effective treatment is found. Because AZT is known to prolong survival in patients with AIDS or severe ARC and has acceptable toxicity in advanced disease, it is reasonable to try it in less advanced cases.
Patients entered in the study are randomly assigned to one of two doses of AZT or to placebo (inactive medication). Patients take 3 capsules 5 times a day (every 4 hours from 8 am until 12 pm).
The capsules contain either AZT or placebo and are identical in appearance so that neither patient nor physician knows which treatment the patient is receiving. The higher dose corresponds to the dose found to be useful in patients with AIDS or severe ARC. Patients visit the clinic every 2 weeks for the first 16 weeks, then once a month after that for evaluation. Treatment will continue until the results from the study have been analyzed, which could be as long as 3 years. If side effects occur, the dose of study medication will be decreased or temporarily stopped. If the side effects are severe, then study medication will be stopped permanently.
AMENDED: Effective with Version 4 (900226), dosing for ALL patients on Phase 2 study drug, regardless of CD4+ substudy, will proceed as open-label AZT. Original treatment assignments employed in the \> 500 cells/mm3 substudy during the period from August 16, 1989 through the release of this new version. Also, toxicity management and dose modification of AZT for patients receiving Phase 2 study drug have been changed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (43)
Montefiore Med Ctr / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
🇺🇸Bronx, New York, United States
SUNY / Erie County Med Ctr at Buffalo
🇺🇸Buffalo, New York, United States
Mem Sloan - Kettering Cancer Ctr
🇺🇸New York, New York, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
🇺🇸Saint Louis, Missouri, United States
Cornell Univ Med Ctr
🇺🇸New York, New York, United States
Palo Alto Veterans Adm Med Ctr / Stanford Univ
🇺🇸Palo Alto, California, United States
Jack Weiler Hosp / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Harvard (Massachusetts Gen Hosp)
🇺🇸Boston, Massachusetts, United States
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
SUNY - Stony Brook
🇺🇸Stony Brook, New York, United States
Univ of California / San Diego Treatment Ctr
🇺🇸San Diego, California, United States
Northwestern Univ Med School
🇺🇸Chicago, Illinois, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, United States
Beth Israel Deaconess - West Campus
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Med Ctr
🇺🇸Boston, Massachusetts, United States
SUNY / State Univ of New York
🇺🇸Syracuse, New York, United States
Univ Hosp of Cleveland / Case Western Reserve Univ
🇺🇸Cleveland, Ohio, United States
Univ of Pittsburgh Med School
🇺🇸Pittsburgh, Pennsylvania, United States
Univ of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Summitt Med Ctr / San Francisco Gen Hosp
🇺🇸Oakland, California, United States
UCLA CARE Ctr
🇺🇸Los Angeles, California, United States
Stanford Univ School of Medicine
🇺🇸Stanford, California, United States
Harbor UCLA Med Ctr
🇺🇸Torrance, California, United States
George Washington Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Bronx Veterans Administration / Mount Sinai Hosp
🇺🇸Bronx, New York, United States
Beth Israel Med Ctr / Peter Krueger Clinic
🇺🇸New York, New York, United States
Saint Luke's - Roosevelt Hosp Ctr
🇺🇸New York, New York, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Holmes Hosp / Univ of Cincinnati Med Ctr
🇺🇸Cincinnati, Ohio, United States
Columbus Children's Hosp
🇺🇸Columbus, Ohio, United States
Ohio State Univ Hosp Clinic
🇺🇸Columbus, Ohio, United States
Julio Arroyo
🇺🇸West Columbia, South Carolina, United States
Univ of Washington
🇺🇸Seattle, Washington, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
San Francisco AIDS Clinic
🇺🇸San Francisco, California, United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
🇺🇸San Francisco, California, United States
Children's Hosp of San Francisco
🇺🇸San Francisco, California, United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
🇺🇸Elmhurst, New York, United States