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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.

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
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (10)

Chelsea Village Med Ctr

🇺🇸

New York, New York, United States

Goodgame Med Group

🇺🇸

Maitland, Florida, United States

Infectious Disease Physicians Inc

🇺🇸

Annandale, Virginia, United States

UCI

🇺🇸

Irvine, California, United States

Southwest Community Based AIDS Treatment Group - COMBAT

🇺🇸

Los Angeles, California, United States

Portland Veterans Adm Med Ctr / Rsch & Education Grp

🇺🇸

Portland, Oregon, United States

Dr Alfred F Burnside Jr

🇺🇸

Columbia, South Carolina, United States

San Francisco Veterans Administration Med Ctr

🇺🇸

San Francisco, California, United States

Mem Hosp Hollywood

🇺🇸

Hollywood, Florida, United States

Gottlieb Med Group

🇺🇸

Sherman Oaks, California, United States

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