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Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
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, Acquired Immunodeficiency Syndrome

Eligibility Criteria

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

Inclusion Criteria Concurrent Medication: Allowed: Aerosolized pentamidine. Prior Medication: Allowed: Aerosolized pentamidine. Exclusion Criteria Co-existing Condition: Patients with an abnormal chest x-ray indicative of active disease (opportunistic infection) within 30 days prior to entry are excluded. Concurrent Medication: Excluded within 90 days of study entry: Zidovudine (AZT). Prior Medication: Excluded within 30 days of study entry: Immunomodulatory or experimental therapy. Excluded within 90 days of study entry: Zidovudine (AZT). Patients must not have: Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products. AIDS as defined by the CDC (except for those with HIV "wasting syndrome"). Significant hepatic disease. Thrombocytopenia (< 75000 platelets/mm3). Patient must voluntarily sign consent and be seropositive for HIV-1 (ELISA assay) confirmed by Western blot. HIV-1 p24 antigen must be detected in supernatant fluids from co-cultures of patient's peripheral blood monocytes (PBMC) on two separate occasions. Patients with HIV "wasting syndrome" are included. Intravenous drug abuse.

Sites / Locations

  • Immunobiology Research Institute

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
NCT00002066
Brief Title
Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection
Official Title
Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
November 1989
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
Examine the ability of thymopentin (Timunox) to: Reduce the amount and/or frequency of virus isolation. Stimulate the immune system and alter the clinical findings in patients infected with HIV who do not yet have AIDS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Thymopentin, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double

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 Concurrent Medication: Allowed: Aerosolized pentamidine. Prior Medication: Allowed: Aerosolized pentamidine. Exclusion Criteria Co-existing Condition: Patients with an abnormal chest x-ray indicative of active disease (opportunistic infection) within 30 days prior to entry are excluded. Concurrent Medication: Excluded within 90 days of study entry: Zidovudine (AZT). Prior Medication: Excluded within 30 days of study entry: Immunomodulatory or experimental therapy. Excluded within 90 days of study entry: Zidovudine (AZT). Patients must not have: Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products. AIDS as defined by the CDC (except for those with HIV "wasting syndrome"). Significant hepatic disease. Thrombocytopenia (< 75000 platelets/mm3). Patient must voluntarily sign consent and be seropositive for HIV-1 (ELISA assay) confirmed by Western blot. HIV-1 p24 antigen must be detected in supernatant fluids from co-cultures of patient's peripheral blood monocytes (PBMC) on two separate occasions. Patients with HIV "wasting syndrome" are included. Intravenous drug abuse.
Facility Information:
Facility Name
Immunobiology Research Institute
City
Annandale
State/Province
New Jersey
ZIP/Postal Code
088010999
Country
United States

12. IPD Sharing Statement

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Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection

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