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. 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

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Thymic Humoral Factor Drug: Zidovudine Phase 2

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 : Interventional  (Clinical Trial)
Masking: Double
Primary Purpose: Treatment
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 Cells/mm3

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Zidovudine

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002435

United States, California
Irvine, California, United States, 92717
Southwest Community Based AIDS Treatment Group - COMBAT
Los Angeles, California, United States, 90028
San Francisco Veterans Administration Med Ctr
San Francisco, California, United States, 94121
Gottlieb Med Group
Sherman Oaks, California, United States, 91403
United States, Florida
Mem Hosp Hollywood
Hollywood, Florida, United States, 33021
Goodgame Med Group
Maitland, Florida, United States, 32751
United States, New York
Chelsea Village Med Ctr
New York, New York, United States, 10014
United States, Oregon
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States, 97210
United States, South Carolina
Dr Alfred F Burnside Jr
Columbia, South Carolina, United States, 29204
United States, Virginia
Infectious Disease Physicians Inc
Annandale, Virginia, United States, 22203
Sponsors and Collaborators
Pharmacia Identifier: NCT00002435     History of Changes
Other Study ID Numbers: 136A
CS 112010-999
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: February 1998

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Antiviral Agents
thymic humoral factor gamma 2

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Thymic humoral factor gamma 2
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs