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

Phase 2

Completed

• Conditions: HIV Infections

• Registration Number: NCT00002435
• Lead Sponsor: Pharmacia

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 1998-02
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (10)

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