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



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

For Condition: HIV Infections
Status: Completed
Sponsor(s): Immunobiology Research Institute ,
Synopsis: To evaluate the mechanism whereby thymopentin appears to retard the progressive immune suppression attributable to HIV infection.
Details: Patients are randomized to receive subcutaneous thymopentin or placebo thrice weekly for 4 weeks.
Eligibility:
Study Type:  Interventional, Treatment, Double-Blind, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 60

Location and Contact Information:

Dr Jeffrey Galpin
Tarzana,  California,  91356
United States
 

Novum Inc
Pittsburgh,  Pennsylvania,  15206
United States
 

Dr Marcus Conant
San Francisco,  California,  94115
United States
 


Additional Information:
Study ID Numbers:  015I;  07.32.039-94
Study Start Date: 
Record last reviewed: December 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002332

Other Hiv Infections Studies:
1. HIV Prevention Preparedness Study

2. The Effectiveness of Two Anti-HIV Treatments in HIV-Infected Patients

3. A Comparison of Three Treatments for Advanced HIV Disease in Patients Who Have Received Nucleoside Therapy in the Past

4. Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen

5. Interleukin-2 Plus Anti-HIV Therapy in HIV-Infected Children with Weakened Immune Systems

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