A Study of Thymic Humoral Factor (THF Gamma 2) in HIV-Infected Patients
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Antiviral Agents, Zidovudine, thymic humoral factor gamma 2
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: AZT or another antiretroviral agent (marketed or investigational under a Treatment IND). Primary prophylaxis for Pneumocystis carinii pneumonia (PCP), toxoplasmosis, and Mycobacterium avium-intracellulare (MAI) if patient's CD4 count decreases to < 200 cells/mm3. Other marketed drugs as required. Patients must have: HIV seropositivity and be either asymptomatic or have persistent generalized lymphadenopathy (PGL). No history of symptoms in Category B or C of 1993 Case Definition, other than oral candidiasis following previous broad-spectrum antibiotic therapy. Mean CD4 of 200-500 cells/mm3. HIV-1 positive PCR RNA. Ability to self-administer study drug by IM injection. Ability to tolerate AZT at 600 mg daily during first 8 weeks of run-in period (if AZT naive) OR tolerated AZT at >= 500 mg daily for at least 3 months but no more than 12 months prior to randomization. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Malignancy. Hematuria. Proteinuria > 1+. Concurrent Medication: Excluded: Non-antiretroviral agents with known or suspected activity against HIV. Investigational new drugs that are not antiretroviral agents distributed under a Treatment IND. Patients with the following prior conditions are excluded: Myositis within the past 6 months. Prior Medication: Excluded: Experimental therapy, including interleukin-2, interferon, erythropoietin, or filgrastim nucleoside within 6 weeks prior to study entry. Prior antiretroviral therapy (AZT-naive patients only). Prior Treatment: Excluded within 6 weeks prior to study entry: Blood transfusion or blood products. Active alcoholism, drug abuse, or a mental or psychiatric problem sufficient to prevent adequate compliance with study.
Sites / Locations
- UCI
- Southwest Community Based AIDS Treatment Group - COMBAT
- San Francisco Veterans Administration Med Ctr
- Gottlieb Med Group
- Mem Hosp Hollywood
- Goodgame Med Group
- Chelsea Village Med Ctr
- Portland Veterans Adm Med Ctr / Rsch & Education Grp
- Dr Alfred F Burnside Jr
- Infectious Disease Physicians Inc