Completed
Thymopentin's Effect on Lymphoproliferative Responses and Virus Load in HIV-Infected Patients
What is being tested
Thymopentin
Drug
Who is being recruted
Blood-Borne Infections+13
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+11 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Summary
Principal SponsorImmunobiology Research Institute
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Patients are randomized to receive subcutaneous thymopentin or placebo thrice weekly for 4 weeks.
Principal SponsorImmunobiology Research Institute
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAIDS-Related ComplexHIV Infections
Criteria
3 inclusion criteria required to participate
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
8 exclusion criteria prevent from participating
Abnormal chest x-ray consistent with active opportunistic infection within 6 weeks prior to study entry
Any antiretroviral agents other than zidovudine, didanosine, or dideoxycytidine
Any prior antiretroviral agents other than zidovudine, didanosine, or dideoxycytidine within 30 days prior to study entry
Grade 2 or higher peripheral neuropathy related to nucleoside analog antiretroviral treatment
Show More Criteria
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Dr Jeffrey Galpin
Tarzana, United StatesNovum Inc
Pittsburgh, United StatesCompleted3 Study Centers