A Multicenter, Double Blind, Comparative Study of Zidovudine Alone Versus Zidovudine and Acyclovir as Treatment for HIV-Infected Patients With CD4+ Counts Less Than 200 Cells/mm3

Inclusion Criteria

Concurrent Medication:

Allowed:

• Methadone maintenance. Therapies available through expanded access or treatment IND programs unless specifically excluded.
• Allowed within 30 days of study entry:
• Systemic steroids only if given for treatment of Pneumocystis carinii pneumonia.
• Recommended:
• PCP prophylaxis.

Patient must have:

• Recovered from first episode of histologically proven Pneumocystis carinii pneumonia (PCP) or microbiologically proven AIDS-defining opportunistic infection as defined in Centers for Disease Control HIV classification group IV.
• C-1.
• Study entry must be within 120 days of AIDS-defining diagnosis.
• Written documentation of positive antibody to HIV by any federally licensed ELISA test kit. This test should be confirmed by another method, for example, Western blot, radioimmunoassay (RIA), HIV culture.
• Patients cannot be transfusion dependent (requiring blood transfusion more than once per month). The last transfusion must be > 2 weeks before entry.
• AMENDED 90-08-27 to include HIV positive patients with CD4+ count < 200 cells/mm3.

Prior Medication:

Allowed:

• Zidovudine (AZT) for < 365 days prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

• Symptomatic visceral or progressive Kaposi's sarcoma (KS) (defined by > 10 new lesions in the 30 days prior to entry).
• Other concurrent neoplasms other than basal cell carcinoma of skin (patients who have been in complete remission for 1 year for a malignancy may be enrolled).
• Malabsorption as defined by persistent diarrhea > 6 stools/day for > 4 weeks. Patients whose sole AIDS-defining condition is constitutional disease as defined in CDC's HIV group IV-A or neurologic disease as defined in CDC's HIV group IV-B or AIDS-associated malignancies as defined in CDC's HIV group IV-C.

Concurrent Medication:

Excluded:

• Acyclovir (ACV) prophylaxis or frequent (> once per month) repeated courses of ACV therapy for herpes simplex virus infection.
• Any concomitant medicine unless required.
• Systemic therapy/prophylaxis/maintenance for AIDS-defining opportunistic infection other than prophylaxis for Pneumocystis carinii pneumonia (PCP).
• Acetaminophen for > 72 hours. Cimetidine.
• Flurazepam.
• Indomethacin.
• Ranitidine.
• Probenecid (if receiving AZT).
• Rifampin.
• Rifampin-related drugs.

Patients with the following are excluded:

• Active opportunistic infections.
• Symptomatic visceral or progressive Kaposi's sarcoma (KS) (defined by > 10 new lesions in the 30 days prior to entry).
• Other concurrent neoplasms other than basal cell carcinoma of skin (patients who have been in complete remission for 1 year for a malignancy may be enrolled).
• Malabsorption as defined by persistent diarrhea > 6 stools/day for > 4 weeks.
• Patients whose sole AIDS-defining condition is constitutional disease as defined in CDC's HIV group IV-A or neurologic disease as defined in CDC's HIV group IV-B or AIDS-associated malignancies as defined in CDC's HIV group IV-C.

Prior Medication:

Excluded:

• Zidovudine (AZT) for > 365 days prior to study entry.
• Excluded within 14 days of study entry:
• Systemic acyclovir (ACV) therapy.
• Excluded within 30 days of study entry:
• Antiretroviral therapy (other than AZT per above).
• Immunomodulating agents.
• Biologic response modifiers.

Excluded within 60 days of study entry:

• Ribavirin.

Prior Treatment:

Excluded within 30 days of study entry:

• Cytotoxic chemotherapy or radiation therapy for Kaposi's sarcoma.

Active substance abuse that would impair compliance with study procedure.