The Safety and Effectiveness of Hydroxyurea and ddI Used Individually or Together in HIV-Infected Patients

Inclusion Criteria

Concurrent Medication:

Allowed:

AS PER AMENDMENT 5/5/97:

• PCP prophylaxis with trimethoprim/sulfamethoxazole or Dapsone.

Patients must have:

• HIV-1 infection.
• AS PER AMENDMENT 5/5/97:
• CD4 count of 200 - 700 cells/mm3 within 60 days prior to study entry.
• AS PER AMENDMENT 10/1/97:
• HIV RNA plasma level < 20,000 copies/ml within 60 days of enrollment (obtained at a laboratory certified to perform the Roche Monitor assay).

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms or conditions are excluded:

• CMV, MAC, toxoplasmosis, or disseminated fungal infection requiring acute or chronic therapy.
• Significant medical illness as determined by investigator.
• Active diagnosis of any malignancy, including visceral Kaposi's sarcoma or extensive cutaneous Kaposi's sarcoma for which systemic chemotherapy is anticipated within the next 24 weeks.
• Current Grade 2 or greater peripheral neuropathy.

Concurrent Medication:

Excluded:

• Acute or chronic therapy for CMV, MAC, toxoplasmosis, or disseminated fungal infection.

AS PER AMENDMENT 5/5/97:

• All antiretroviral medications other than those provided on study.
• Systemic chemotherapy for active malignancies, including systemic treatment for KS.
• Agents with myelosuppressive potential, including tegretol, carboplatin, carmustine, cyclophosphamide and fluorouracil.
• Granulocyte colony stimulating factor (G-CSF) except while hydroxyurea or matching placebo is held.

Drugs associated with peripheral neuropathy, including:

• hydralazine, disulfiram, nitrofurantoin, cisplatinum, diethyldithiocarbamate, gold, rifampin, chloramphenicol, clioquinol, ethambutol, ethionamide, glutethimide, sodium cyanate, and thalidomide.

Patients with any of the prior conditions are excluded:

• History of transfusion dependent anemia, defined as any history of repeated transfusion with two or more units of red blood cells.
• At the discretion of the investigator, history of pancreatitis.

Prior Medication:

Excluded:

• More than 2 weeks prior treatment with ddI.

AS PER AMENDMENT 5/5/97:

• Other antiretrovirals must be discontinued at least 14 days prior to randomization.
• Prior hydroxyurea.
• Any candidate HIV vaccine or agent with potential immune modulating effects within the past 30 days.
• Any colony stimulating factor or erythropoietin within the past 60 days.

Prior Treatment:

Excluded:

• Transfusion with red blood cells within the past 60 days.

Risk Behavior:

Excluded:

• At the investigator's discretion, any active substance abuse, including alcohol abuse interfering with compliance.