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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00002435
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

November 2, 1999
August 31, 2001
June 24, 2005
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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
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.
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.
Phase 2
Masking: Double
Primary Purpose: Treatment
HIV Infections
  • Drug: Thymic Humoral Factor
  • Drug: Zidovudine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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Inclusion Criteria

Concurrent Medication:


  • 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:


  • 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:


  • 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.
Sexes Eligible for Study: All
13 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
CS 112010-999
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NIH AIDS Clinical Trials Information Service
February 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP