Safety and Efficacy of Zidovudine for Asymptomatic HIV-Infected Individuals
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
Eligibility Criteria
Inclusion Criteria Patients must: Be HIV seropositive and asymptomatic. Have normal neurologic exam as defined by the Micro Neuro-AIDS assessment. Concurrent Medication Required: Prophylaxis for Pneumocystis carinii pneumonia (PCP). Aerosolized pentamidine is preferred but if not possible, Trimethoprim / sulfamethoxazole 1 DS tablet per day or Dapsone 50 - 100 mg per day is allowed. Exclusion Criteria Active drug or alcohol abuse sufficient to prevent adequate compliance with study therapy in the investigator's opinion. Co-existing Condition: Patients with the following diseases or conditions are excluded: Hemophilia. Oral candida infection documented by morphology or by response to antifungal therapy within 2 years of study entry. Oral hairy leukoplakia at any time prior to study entry. Herpes zoster infection (including single dermatome infection) within 2 years of study entry. Active diarrhea as defined by 3 or more liquid stools per day. Temperature > 37.8 degrees C. Grade 1 impairment on two or more items (mild AIDS dementia complex) in the ACTG Micro Neuro-AIDS Assessment. Prior history of malignancy other than cutaneous basal cell carcinomas or cervical carcinoma in situ. Patients with the following are excluded from entry: AIDS or AIDS-related complex defining symptoms. Significant, chronic underlying medical illnesses which would impair continuous participation in this 3-year clinical trial. Hemophilia. Prior Medication: Excluded: Chemoprophylaxis for Pneumocystis carinii pneumonia (PCP). Other experimental medications. Excluded within 60 days of study entry: Antiretroviral drugs or immunomodulators (biologic response modifiers). Excluded within 120 days of study entry: Systemic corticosteroids. Prior Treatment: Excluded within 3 months of study entry: Blood transfusion.
Sites / Locations
- Los Angeles County - USC Med Ctr
- UCLA CARE Ctr
- Summitt Med Ctr / San Francisco Gen Hosp
- Palo Alto Veterans Adm Med Ctr / Stanford Univ
- Univ of California / San Diego Treatment Ctr
- San Francisco AIDS Clinic / San Francisco Gen Hosp
- Stanford at Kaiser / Kaiser Permanente Med Ctr
- Children's Hosp of San Francisco
- San Francisco AIDS Clinic
- Stanford Univ School of Medicine
- Harbor UCLA Med Ctr
- George Washington Univ Med Ctr
- Northwestern Univ Med School
- Rush Presbyterian - Saint Luke's Med Ctr
- Johns Hopkins Hosp
- Harvard (Massachusetts Gen Hosp)
- Beth Israel Deaconess - West Campus
- Beth Israel Deaconess Med Ctr
- Univ of Minnesota
- St Louis Regional Hosp / St Louis Regional Med Ctr
- Bronx Municipal Hosp Ctr/Jacobi Med Ctr
- Jack Weiler Hosp / Bronx Municipal Hosp
- Montefiore Med Ctr / Bronx Municipal Hosp
- Bronx Veterans Administration / Mount Sinai Hosp
- SUNY / Erie County Med Ctr at Buffalo
- City Hosp Ctr at Elmhurst / Mount Sinai Hosp
- Beth Israel Med Ctr / Peter Krueger Clinic
- Bellevue Hosp / New York Univ Med Ctr
- Cornell Univ Med Ctr
- Mem Sloan - Kettering Cancer Ctr
- Saint Luke's - Roosevelt Hosp Ctr
- Mount Sinai Med Ctr
- Univ of Rochester Medical Center
- SUNY - Stony Brook
- SUNY / State Univ of New York
- Duke Univ Med Ctr
- Holmes Hosp / Univ of Cincinnati Med Ctr
- Univ Hosp of Cleveland / Case Western Reserve Univ
- Columbus Children's Hosp
- Ohio State Univ Hosp Clinic
- Univ of Pittsburgh Med School
- Julio Arroyo
- Univ of Washington