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

June 23, 2005 updated by: Pharmacia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92717
        • UCI
      • Los Angeles, California, United States, 90028
        • Southwest Community Based AIDS Treatment Group - COMBAT
      • San Francisco, California, United States, 94121
        • San Francisco Veterans Administration Med Ctr
      • Sherman Oaks, California, United States, 91403
        • Gottlieb Med Group
    • Florida
      • Hollywood, Florida, United States, 33021
        • Mem Hosp Hollywood
      • Maitland, Florida, United States, 32751
        • Goodgame Med Group
    • New York
      • New York, New York, United States, 10014
        • Chelsea Village Med Ctr
    • Oregon
      • Portland, Oregon, United States, 97210
        • Portland Veterans Adm Med Ctr / Rsch & Education Grp
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Dr Alfred F Burnside Jr
    • Virginia
      • Annandale, Virginia, United States, 22203
        • Infectious Disease Physicians Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmacia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

February 1, 1998

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 136A
  • CS 112010-999

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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