A Study of AZT in HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma
- Conditions
- HIV Infections
- Registration Number
- NCT00000994
- Brief Summary
To determine whether taking zidovudine (AZT) will change the natural course of HIV infection in patients with AIDS-associated Kaposi's sarcoma (KS) and whether administering AZT at a similar dose but at different intervals will reduce toxicity in a more manageable treatment plan.
Patients infected with AIDS can benefit from therapy with an effective anti-AIDS virus agent. AZT is a drug that is effective in inhibiting the effects of HIV infection. The study will show whether toxicity of AZT can be reduced in a more manageable treatment plan, and whether AZT therapy will delay the development of opportunistic infections and/or KS lesions.
- Detailed Description
Patients infected with AIDS can benefit from therapy with an effective anti-AIDS virus agent. AZT is a drug that is effective in inhibiting the effects of HIV infection. The study will show whether toxicity of AZT can be reduced in a more manageable treatment plan, and whether AZT therapy will delay the development of opportunistic infections and/or KS lesions.
Patients are divided into two treatment groups, the first receiving AZT for 5 doses a day, and the second receiving AZT for 3 doses per day. A placebo group is divided into two to match the two treatment groups. Study patients are stratified according to whether they have (a) 10 or fewer cutaneous lesions without oral lesions or (b) more extensive cutaneous lesions or oral lesions. Patients are seen on an outpatient basis weekly for the first 2 months, every other week for the next 2 months, and monthly thereafter.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 240
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 (22)
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
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, United States
Harvard (Massachusetts Gen Hosp)
🇺🇸Boston, Massachusetts, United States
Univ of Minnesota
🇺🇸Minneapolis, Minnesota, United States
SUNY / State Univ of New York
🇺🇸Syracuse, New York, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Stanford Univ School of Medicine
🇺🇸Stanford, California, United States
SUNY / Erie County Med Ctr at Buffalo
🇺🇸Buffalo, New York, United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
🇺🇸Elmhurst, New York, United States
Beth Israel Med Ctr / Peter Krueger Clinic
🇺🇸New York, New York, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Mem Sloan - Kettering Cancer Ctr
🇺🇸New York, New York, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
Bronx Veterans Administration / Mount Sinai Hosp
🇺🇸Bronx, New York, United States
Tulane Univ School of Medicine
🇺🇸New Orleans, Louisiana, 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