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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Thymic Humoral Factor
Zidovudine
Sponsored by
Pharmacia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Antiviral Agents, Zidovudine, thymic humoral factor gamma 2

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCI
  • Southwest Community Based AIDS Treatment Group - COMBAT
  • San Francisco Veterans Administration Med Ctr
  • Gottlieb Med Group
  • Mem Hosp Hollywood
  • Goodgame Med Group
  • Chelsea Village Med Ctr
  • Portland Veterans Adm Med Ctr / Rsch & Education Grp
  • Dr Alfred F Burnside Jr
  • Infectious Disease Physicians Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Pharmacia
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1. Study Identification

Unique Protocol Identification Number
NCT00002435
Brief Title
A Study of Thymic Humoral Factor (THF Gamma 2) in HIV-Infected Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 1998
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pharmacia

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Antiviral Agents, Zidovudine, thymic humoral factor gamma 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Thymic Humoral Factor
Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
UCI
City
Irvine
State/Province
California
ZIP/Postal Code
92717
Country
United States
Facility Name
Southwest Community Based AIDS Treatment Group - COMBAT
City
Los Angeles
State/Province
California
ZIP/Postal Code
90028
Country
United States
Facility Name
San Francisco Veterans Administration Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Gottlieb Med Group
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Mem Hosp Hollywood
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Goodgame Med Group
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Chelsea Village Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10014
Country
United States
Facility Name
Portland Veterans Adm Med Ctr / Rsch & Education Grp
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Dr Alfred F Burnside Jr
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Infectious Disease Physicians Inc
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22203
Country
United States

12. IPD Sharing Statement

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

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