Completed
Thalidomide's Immune Response Potentiation in HIV-Infected Patients
What is being tested
Thalidomide
Drug
Who is being recruted
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+9 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Summary
Principal SponsorLouisiana State University Health Sciences Center in New Orleans
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Patients will be divided, 5 per group, into Groups I, II, III and IV. Groups I and II will include patients who have decided not to take anti-retro viral drugs. Groups III and IV will include patients receiving the same types of antiretroviral drugs. Patients in groups I and III will receive thalidomide while patients in group II and IV will receive placebo. The placebo capsules will be the same color as the thalidomide capsules and will contain glucose powder. Patients will ingest one capsule of thalidomide at 9 PM daily on days 0, 1, 2, 3, 4, 5 and 6.
Principal SponsorLouisiana State University Health Sciences Center in New Orleans
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
20 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 DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections
Criteria
5 inclusion criteria required to participate
CD4+ cell count >= 200/microliter or > 14% CD4+ cells in peripheral blood
HIV infection
Willingness to commit to the study duration and agree to abide to the time table for entry into the study, ingestion of thalidomide and follow-up
Must be on antiretroviral therapy
Show More Criteria
4 exclusion criteria prevent from participating
Fertile females
HIV related pre-existing peripheral neuropathy
Patients using systemic steroidal anti inflammatory drugs or pentoxifylline within 10 days of dosing with thalidomide
Patients who participated in a clinical study involving a new drug or device within the last 2 months or the period of time equivalent to seven times the half life of the study drug, whichever is longer
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 1 location
CompletedOne Study Center