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.