Safety and Efficacy of Zidovudine for Asymptomatic HIV-Infected Individuals

Inclusion 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.