Completed

Thalidomide vs Placebo in Mycobacterium and/or HIV Infections

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Thalidomide

Drug
Who is being recruted

Blood-Borne Infections+24

+ Urogenital Diseases

+ Genital Diseases

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorAaron Diamond AIDS Research Center
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Patients are randomized to receive thalidomide or placebo orally at 9 PM the night before beginning anti-tuberculosis chemotherapy and continuing nightly for 7 nights. Patients are followed for 28 days. Patients are stratified according to HIV status and stage of HIV infection.

NCT00002104
Principal SponsorAaron Diamond AIDS Research Center
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.

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.

From 18 to 65 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 DiseasesActinomycetales InfectionsBacterial Infections and MycosesBacterial InfectionsCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsOpportunistic InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsGram-Positive Bacterial InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexMycobacterium InfectionsMycobacterium Infections, NontuberculousTuberculosisMycobacterium avium-intracellulare InfectionHIV InfectionsAIDS-Related Opportunistic Infections

Criteria

Inclusion Criteria Patients must have: Positive AFB smear and/or culture for Mycobacterium tuberculosis, M. avium, or other mycobacterial infection, with or without documented HIV infection. NOTE: HIV-positive patients must have CD4 count < 500 cells/mm3 and be on antiretroviral therapy. One of the following manifestations: Temperature over 38 C on at least two occasions in the week prior to study entry. Recent weight loss of more than 5 kilograms. Pulmonary involvement of one or more lobes or involvement of other tissues due to tuberculosis or other mycobacterial infections, or symptomatic infections related to HIV status. Night sweats on two or more occasions in the week prior to study entry. NOTE: Patients must be hospitalized men aged 18-65 and postmenopausal women to age 65. Anticipated requirement for hospitalization must be at least 10 days. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Neuropathy or other disorders with risk of neuropathy. Required for HIV-positive patients if CD4 count < 500 cells/mm3: Antiretroviral therapy.

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 2 locations

Bellevue Hosp Ctr

New York, United StatesOpen Bellevue Hosp Ctr in Google Maps

Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ

New York, United States
Completed2 Study Centers