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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002435
• Other study ID #: 136A
• Secondary ID: CS 112010-999
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: February 1998
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Thymic Humoral Factor

• Zidovudine

Locations

Country	Name	City	State
United States	Infectious Disease Physicians Inc	Annandale	Virginia
United States	Dr Alfred F Burnside Jr	Columbia	South Carolina
United States	Mem Hosp Hollywood	Hollywood	Florida
United States	UCI	Irvine	California
United States	Southwest Community Based AIDS Treatment Group - COMBAT	Los Angeles	California
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	San Francisco Veterans Administration Med Ctr	San Francisco	California
United States	Gottlieb Med Group	Sherman Oaks	California

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacia

Country where clinical trial is conducted

United States,