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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study of the Activity of Thymic Humoral Factor (THF Gamma 2) on HIV Load in HIV-Positive Individuals With CD4+ Cell Counts in the Range of 200-500 Cells/mm3

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Thymic Humoral Factor
* Drug: Zidovudine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Thymic Humoral Factor|nan|
|Drug: Zidovudine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy, Combination, Antiviral Agents, Zidovudine, thymic humoral factor gamma 2