Trials / Completed
CompletedNCT00002435
A Study of Thymic Humoral Factor (THF Gamma 2) in HIV-Infected Patients
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Pharmacia · Industry
- Sex
- All
- Age
- 13 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Thymic Humoral Factor | |
| DRUG | Zidovudine |
Timeline
- First posted
- 2001-08-31
- Last updated
- 2005-06-24
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00002435. Inclusion in this directory is not an endorsement.