A Prospective Double-Blind Study of Retrovir in Early HIV Infection

Inclusion Criteria

Concurrent Treatment:

Allowed:

• Electron beam therapy to an area of less than 100 cm2.

Patient must have signs and symptoms of HIV infection confined to those of stages WRII-V or CDC groups III IV-A, IV-C-2 (except recurrent Salmonella bacteremia, nocardiosis, or disseminated/extrapulmonary Mycobacterium tuberculosis), and IV-E (except diffuse interstitial lymphoid pneumonitis).

• Patient must be able to give informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

• Evidence of nervous system dysfunction caused by factors other than HIV infection, including chronic alcohol or drug abuse.
• Present or prior known AIDS-defining opportunistic infections, lymphomas, or malignancies based on CDC criteria.
• Present or prior known systemic opportunistic diseases most recently included in the expanded CDC definition of AIDS:
• extrapulmonary or disseminated Mycobacterium tuberculosis infections, recurrent nontyphoidal Salmonella septicemia, coccidioidomycosis, diffuse interstitial lymphoid pneumonitis.
• Evidence of compromised bone marrow function defined by specified lab values.
• Evidence of HIV neurologic disease.
• Evidence of HIV-associated "wasting syndrome".
• Hypersensitivity to zidovudine (AZT).

Concurrent Medication:

Excluded:

• Cytotoxic chemotherapeutic agents.
• Steroids.
• Interferon or immunomodulating agents.
• Any antiretroviral drug including, but not limited to zidovudine (AZT), ribavirin, HPA23, AL 721, or phosphonoformate.

Patients with the following are excluded:

• Evidence of nervous system dysfunction caused by factors other than HIV infection, including chronic alcohol or drug abuse. Present or prior known AIDS-defining opportunistic infections, lymphomas, or malignancies based on CDC criteria. Present or prior known systemic opportunistic diseases most recently included in the expanded CDC definition of AIDS:
• extrapulmonary or disseminated Mycobacterium tuberculosis infections, recurrent nontyphoidal Salmonella septicemia, coccidioidomycosis, diffuse interstitial lymphoid pneumonitis.
• Evidence of compromised bone marrow function defined by specified lab values. Evidence of HIV neurologic disease.
• Evidence of HIV-associated wasting syndrome.
• Hypersensitivity to retrovir.

Prior Medication:

Excluded within 4 weeks of study entry:

• Interferon.
• Immunomodulating agents.
• Myelosuppressive drugs.
• Nephrotoxic agents.
• Other experimental chemotherapy.

Prior Treatment:

Excluded:

• Treatment with radiation therapy (with the exception of electron beam therapy to an area of less than 100 cm2).

Chronic alcohol or drug abuse.