Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

November 2, 1999
June 23, 2005
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00002435 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
  • Drug: Thymic Humoral Factor
  • Drug: Zidovudine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002435
136A, CS 112010-999
Not Provided
Not Provided
Pharmacia
Not Provided
Not Provided
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