- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002332
A Study of Timunox (Thymopentin) in HIV-Infected Patients Receiving Other Anti-HIV Drugs
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 Overview
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94115
- Dr Marcus Conant
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Tarzana, California, United States, 91356
- Dr Jeffrey Galpin
-
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15206
- Novum Inc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: Double
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Physiological Effects of Drugs
- Immunologic Factors
- Adjuvants, Immunologic
- Thymopentin
Other Study ID Numbers
- 015I
- 07.32.039-94
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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