Pilot Study to Evaluate the Efficacy of Zidovudine in Preventing CD4+ Lymphocyte Decline in Patients With Primary HIV Infection. (One Treatment Arm Receives Placebo)

Inclusion Criteria

Concurrent Medication:

Allowed:

• Medications for nausea, vomiting, analgesia, or anxiety.

Patients must have:

• Asymptomatic or symptomatic primary HIV infection, plus one of the following two criteria:

  1. p24 antigenemia documented within 1 month prior to study entry and either HIV enzyme immunoassay (IA) negative or HIV IA positive with Western blot negative/indeterminate, within 1 month prior to study entry.
  2. Documented seroconversion within 1 month prior to study entry and Western blot negative/indeterminate.

• Consent of parent or guardian if less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following condition are excluded:

• poor venous access.

Concurrent Medication:

Excluded:

• Chronic steroid use.
• Immunomodulators.
• Myelosuppressive agents.
• Other antiretroviral agents or experimental therapies (NOTE: FDA-approved therapies permitted in patients who qualify after week 24; experimental therapies permitted after study week 48).

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety