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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

To investigate the safety of thymic humoral factor (THF gamma 2), its effect on HIV load based on at least a 75 percent decrease in HIV quantitative PCR RNA copies/ml, and its persistence when administered in combination with an antiretroviral nucleoside derivative (zidovudine; AZT). To assess the effects of THF gamma 2 on T-cells, quality of life, and progression of disease.

Key facts

Study ID

NCT00002435

Run by

Pharmacia

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCI — Irvine, California, United States
• Southwest Community Based AIDS Treatment Group - COMBAT — Los Angeles, California, United States
• San Francisco Veterans Administration Med Ctr — San Francisco, California, United States
• Gottlieb Med Group — Sherman Oaks, California, United States
• Mem Hosp Hollywood — Hollywood, Florida, United States
• Goodgame Med Group — Maitland, Florida, United States
• Chelsea Village Med Ctr — New York, New York, United States
• Portland Veterans Adm Med Ctr / Rsch & Education Grp — Portland, Oregon, United States
• Dr Alfred F Burnside Jr — Columbia, South Carolina, United States
• Infectious Disease Physicians Inc — Annandale, Virginia, United States

Full record on ClinicalTrials.gov

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