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

Tracking Information
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
Condition ICMJE	HIV Infections
Intervention ICMJE	Drug: Thymic Humoral Factor; Drug: Zidovudine
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.
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: AZT or another antiretroviral agent (marketed or investigational under a Treatment IND).; Primary prophylaxis for Pneumocystis carinii pneumonia (PCP), toxoplasmosis, and Mycobacterium avium-intracellulare (MAI) if patient's CD4 count decreases to < 200 cells/mm3.; Other marketed drugs as required. Patients must have: HIV seropositivity and be either asymptomatic or have persistent generalized lymphadenopathy (PGL).; No history of symptoms in Category B or C of 1993 Case Definition, other than oral candidiasis following previous broad-spectrum antibiotic therapy.; Mean CD4 of 200-500 cells/mm3.; HIV-1 positive PCR RNA.; Ability to self-administer study drug by IM injection.; Ability to tolerate AZT at 600 mg daily during first 8 weeks of run-in period (if AZT naive) OR tolerated AZT at >= 500 mg daily for at least 3 months but no more than 12 months prior to randomization. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Malignancy.; Hematuria.; Proteinuria > 1+. Concurrent Medication: Excluded: Non-antiretroviral agents with known or suspected activity against HIV.; Investigational new drugs that are not antiretroviral agents distributed under a Treatment IND. Patients with the following prior conditions are excluded: Myositis within the past 6 months. Prior Medication: Excluded: Experimental therapy, including interleukin-2, interferon, erythropoietin, or filgrastim nucleoside within 6 weeks prior to study entry.; Prior antiretroviral therapy (AZT-naive patients only). Prior Treatment: Excluded within 6 weeks prior to study entry: Blood transfusion or blood products. Active alcoholism, drug abuse, or a mental or psychiatric problem sufficient to prevent adequate compliance with study.
Sex/Gender	Sexes Eligible for Study: All
Ages	13 Years and older (Child, Adult, Older Adult)
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
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