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

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.

What this study is about