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.

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