A Study of Thymic Humoral Factor (THF Gamma 2) in HIV-Infected Patients

Launched by PHARMACIA · Aug 30, 2001

Keywords

ClinConnect Summary

All patients receive 12 weeks of AZT before being randomized to self-administer one of two doses of THF gamma 2 or placebo for 15 consecutive days and then twice weekly for an additional 50 weeks.

Gender

ALL

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.