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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002435
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: February 1998
  Purpose

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 Intervention Phase
HIV Infections
Drug: Thymic Humoral Factor
Drug: Zidovudine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
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 NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002435

Locations
United States, California
UCI
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002435     History of Changes
Other Study ID Numbers: 136A, CS 112010-999
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zidovudine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 18, 2014