Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002435
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of Thymic Humoral Factor THF Gamma 2 in HIV-Infected Patients
Sponsor:
Pharmacia
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
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 Cellsmm3
Status:
COMPLETED
Status Verified Date:
1998-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 copiesml 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CS 112010-999 | None | None | None |