The Efficacy and Safety of Retrovir in Patients Infected With HIV Who Are Asymptomatic (CDC Group II) or Have Persistent Generalized Lymphadenopathy (CDC Group III)

Exclusion Criteria

• •Co-existing Condition:
• •Patients with the following are excluded:
• •Prior history of a malignancy other than cutaneous basal cell or cervical carcinomas.
• •Other significant, chronic underlying medical illness which would impair study completion.
• •Liver dysfunction as demonstrated by lab results.
• •Laboratory evidence of compromised bone marrow function.
• •Concurrent Medication:
• •Excluded:
• •Any other experimental agents.
• •Any probenecid-containing product.
• •Patients are excluded if they have a history of symptoms characteristic of CDC class I or IV including any of the following:
• •Unintentional weight loss of greater than 10 lbs, or more than 10 percent of usual body weight within the last 16 weeks.
• •Unexplained fever \> 38.5 degrees C on more than 14 consecutive days or on more than 15 days in the previous 30-day period.
• •Unexplained diarrhea defined by = or \> 2 liquid stools per day persisting for = or \> 14 days or 15 days in any 30-day period.
• •OR History of secondary infections associated with AIDS related complex (ARC) including:
• •Recurrent oral candidiasis documented by morphology or by response to antifungal therapy within 3 years.
• •Herpes zoster infection within 3 years.
• •Oral hairy leukoplakia at any time.
• •OR History of opportunistic disease fulfilling the CDC surveillance definition of AIDS.
• •Signs and symptoms at baseline characteristic of acute HIV disease (CDC group I).
• •Evidence of significant neurologic dysfunction as currently defined by CDC following standard neurologic screening and AIDS Dementia Assessment.
• •Prior Medication:
• •Excluded:
• •\- Previous treatment for greater than 3 months duration with any antiretroviral compound such as zidovudine (AZT).
• •Excluded within 4 weeks of study entry:
• •\- Treatment with any potentially myelosuppressive drug, nephrotoxic agent, or other experimental therapy.
• •Excluded within 3 months of study entry:
• •\- Antiretroviral drugs or biologic response modifiers.
• •Excluded within 4 months of study entry:
• •\- Systemic corticosteroids.
• •Patients must meet the following criteria:
• •HIV infection demonstrated by ELISA and confirmed by Western blot.
• •Signs and symptoms of HIV disease limited to those characteristic of CDC groups II (asymptomatic) and III (persistent generalized lymphadenopathy - PGL).
• •Ability to give informed consent.
• •Willingness to be followed by the originating medical center for the entire 3-year duration of the study.
• •Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.