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A Study of Timunox (Thymopentin) in HIV-Infected Patients Receiving Other Anti-HIV Drugs

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Thymopentin
Sponsored by
Immunobiology Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Thymopentin, AIDS-Related Complex

Eligibility Criteria

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

Inclusion Criteria Patients must have: Asymptomatic or minimally symptomatic HIV infection (no evidence of AIDS). CD4 count <= 400 cells/mm3 within 6 weeks prior to study entry (CD4 count changed to 100 - 400 cells/mm3 per amendment). Tolerated the current nucleoside analog antiretroviral treatment for at least 4 weeks prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Known hypersensitivity to thymopentin or any component of the formulation. Significant chronic underlying medical illness that would impede study participation. Grade 2 or higher peripheral neuropathy related to nucleoside analog antiretroviral treatment. Concurrent Medication: Excluded: Any antiretroviral agents other than zidovudine, didanosine, or dideoxycytidine. HIV vaccines or any investigational or non-FDA approved medication or immunomodulatory or experimental therapy within 30 days prior to study entry. Patients with the following prior condition are excluded: Abnormal chest x-ray consistent with active opportunistic infection within 6 weeks prior to study entry. Prior Medication: Excluded: Any prior antiretroviral agents other than zidovudine, didanosine, or dideoxycytidine within 30 days prior to study entry. Required: Current nucleoside analog antiretroviral treatment. Required: Nucleoside analog antiretroviral treatment for at least 4 weeks prior to study entry. Significant active alcohol or drug abuse sufficient to prevent study compliance.

Sites / Locations

  • Dr Marcus Conant
  • Dr Jeffrey Galpin
  • Novum Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

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

Unique Protocol Identification Number
NCT00002332
Brief Title
A Study of Timunox (Thymopentin) in HIV-Infected Patients Receiving Other Anti-HIV Drugs
Official Title
Double-Blind Study of the Effect of Timunox (Thymopentin) on Lymphoproliferative Responses and Virus Load in HIV-Infected Subjects Receiving Nucleoside Analog Antiretroviral Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
December 1995
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
Immunobiology Research Institute

4. Oversight

5. Study Description

Brief Summary
To evaluate the mechanism whereby thymopentin appears to retard the progressive immune suppression attributable to HIV infection.
Detailed Description
Patients are randomized to receive subcutaneous thymopentin or placebo thrice weekly for 4 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Thymopentin, AIDS-Related Complex

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Thymopentin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients must have: Asymptomatic or minimally symptomatic HIV infection (no evidence of AIDS). CD4 count <= 400 cells/mm3 within 6 weeks prior to study entry (CD4 count changed to 100 - 400 cells/mm3 per amendment). Tolerated the current nucleoside analog antiretroviral treatment for at least 4 weeks prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Known hypersensitivity to thymopentin or any component of the formulation. Significant chronic underlying medical illness that would impede study participation. Grade 2 or higher peripheral neuropathy related to nucleoside analog antiretroviral treatment. Concurrent Medication: Excluded: Any antiretroviral agents other than zidovudine, didanosine, or dideoxycytidine. HIV vaccines or any investigational or non-FDA approved medication or immunomodulatory or experimental therapy within 30 days prior to study entry. Patients with the following prior condition are excluded: Abnormal chest x-ray consistent with active opportunistic infection within 6 weeks prior to study entry. Prior Medication: Excluded: Any prior antiretroviral agents other than zidovudine, didanosine, or dideoxycytidine within 30 days prior to study entry. Required: Current nucleoside analog antiretroviral treatment. Required: Nucleoside analog antiretroviral treatment for at least 4 weeks prior to study entry. Significant active alcohol or drug abuse sufficient to prevent study compliance.
Facility Information:
Facility Name
Dr Marcus Conant
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Dr Jeffrey Galpin
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Novum Inc
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States

12. IPD Sharing Statement

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A Study of Timunox (Thymopentin) in HIV-Infected Patients Receiving Other Anti-HIV Drugs

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