The Safety and Effectiveness of Zidovudine in the Treatment of Patients With Early AIDS Related Complex
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Virus Replication, AIDS-Related Complex, Zidovudine
Eligibility Criteria
Inclusion Criteria Patients must have a positive antibody to HIV confirmed by a federally licensed ELISA test kit. The CD4 cell count must be 201 - 799 cells/mm3 measured on two separate occasions within 60 days at least 72 hours apart prior to study entry (at least 1 of 2 counts and the mean must be < 800 cells/mm3, and at least 1 of 2 counts and the mean must be > 200 cells/mm3). The last count must be within 14 days of study entry. Concurrent Medication: Allowed: Acetaminophen and acetaminophen products but use should be minimized. Continuous use for > 72 hours is discouraged. Aerosolized pentamidine. Prior Medication: Allowed: Chemoprophylaxis for Pneumocystis carinii pneumonia with aerosolized pentamidine of 300 mg every 4 weeks through the Respirgard II nebulizer if patient has CD4(+) count < 200 cells/mm3 measured on 2 determinations at least 48 hours apart. Exclusion Criteria Concurrent Medication: Excluded: Other antiretroviral agents, biologic modifiers or corticosteroids. Other experimental medications. Systemic chemoprophylaxis of Pneumocystic carinii pneumonia (PCP) - aerosolized pentamidine is allowed. Prior Medication: Excluded: Zidovudine (AZT). Other antiretroviral agents. Excluded within 30 days of study entry: Biologic modifiers or corticosteroids. Excluded within 60 days of study entry: Ribavirin. Prior Treatment: Excluded within 30 days of study entry: Blood transfusions. Patients may not have any of the following diseases or symptoms: Active oral candidiasis at entry. An opportunistic infection or malignancy fulfilling the definition of AIDS (CDC Surveillance Case Definition for Acquired Immunodeficiency Syndrome). Temperature > 38.5 degrees C persisting for > 14 consecutive days or > 15 days in a 30-day interval present at entry. Chronic diarrhea defined as = or > 3 liquid stools per day, persisting for > 14 days without a definable cause during the past 2 years. HIV neurologic disease as manifested by motor abnormalities including impaired rapid eye movements or ataxia; motor weakness in the lower extremities; sensory deficit consistent with a peripheral neuropathy; bladder or bowel incontinence. Concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix. Subjects with hemophilia should be evaluated and treated under the hemophilia protocols, if available at that ACTG. Patients may not have any of the following diseases or symptoms: Active oral candidiasis at entry. An opportunistic infection or malignancy fulfilling the definition of AIDS (CDC Surveillance Case Definition for Acquired Immunodeficiency Syndrome). Temperature > 38.5 degrees C persisting for > 14 consecutive days or > 15 days in a 30-day interval present at entry. Chronic diarrhea defined as = or > 3 liquid stools per day, persisting for > 14 days without a definable cause during the past 2 years. HIV neurologic disease as manifested by motor abnormalities including impaired rapid eye movements or ataxia; motor weakness in the lower extremities; sensory deficit consistent with a peripheral neuropathy; bladder or bowel incontinence. Concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix. Subjects with hemophilia should be evaluated and treated under the hemophilia protocols, if available at that ACTG. Active drug or alcohol abuse.
Sites / Locations
- Los Angeles County - USC Med Ctr
- UCLA CARE Ctr
- Palo Alto Veterans Adm Med Ctr / Stanford Univ
- Univ of California / San Diego Treatment Ctr
- Stanford at Kaiser / Kaiser Permanente Med Ctr
- Stanford Univ School of Medicine
- Harbor UCLA Med Ctr
- George Washington Univ Med Ctr
- Univ of Miami School of Medicine
- Northwestern Univ Med School
- Indiana Univ Hosp
- Johns Hopkins Hosp
- Harvard (Massachusetts Gen Hosp)
- Beth Israel Deaconess - West Campus
- 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
- Saint Luke's - Roosevelt Hosp Ctr
- Mount Sinai Med Ctr
- Univ of Rochester Medical Center
- SUNY - Stony Brook
- SUNY / State Univ of New York
- Univ of North Carolina
- 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
- Thomas Jefferson Univ Hosp
- Univ of Pittsburgh Med School
- Julio Arroyo
- Univ of Washington