A Study of Thymic Humoral Factor (THF Gamma 2) in HIV-Infected Patients
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ClinicalTrials.gov Identifier: NCT00002435 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
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Sponsor:
Pharmacia
Information provided by:
NIH AIDS Clinical Trials Information Service
Tracking Information | |||
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First Submitted Date ICMJE | November 2, 1999 | ||
First Posted Date ICMJE | August 31, 2001 | ||
Last Update Posted Date | June 24, 2005 | ||
Study Start Date ICMJE | Not Provided | ||
Primary Completion Date | Not Provided | ||
Current Primary Outcome Measures ICMJE | Not Provided | ||
Original Primary Outcome Measures ICMJE | Not Provided | ||
Change History | No Changes Posted | ||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | A Study of Thymic Humoral Factor (THF Gamma 2) in HIV-Infected Patients | ||
Official Title ICMJE | 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 | ||
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 Type ICMJE | Interventional | ||
Study Phase | Phase 2 | ||
Study Design ICMJE | Masking: Double Primary Purpose: Treatment |
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Condition ICMJE | HIV Infections | ||
Intervention ICMJE |
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Study Arms | Not Provided | ||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Enrollment ICMJE | Not Provided | ||
Original Enrollment ICMJE | Not Provided | ||
Study Completion Date | Not Provided | ||
Primary Completion Date | Not Provided | ||
Eligibility Criteria ICMJE | Inclusion Criteria Concurrent Medication: Allowed:
Patients must have:
Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded:
Concurrent Medication: Excluded:
Patients with the following prior conditions are excluded: Myositis within the past 6 months. Prior Medication: Excluded:
Prior Treatment: Excluded within 6 weeks prior to study entry:
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Sex/Gender |
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Ages | 13 Years and older (Child, Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00002435 | ||
Other Study ID Numbers ICMJE | 136A CS 112010-999 |
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Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Not Provided | ||
Study Sponsor ICMJE | Pharmacia | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | NIH AIDS Clinical Trials Information Service | ||
Verification Date | February 1998 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |