NCT00002104

Brief Summary

To demonstrate, in patients with tubercular or nontubercular mycobacterium infections with or without HIV infection, the safety of thalidomide use as judged by symptoms, physical exam, and studies of microbiologic, immunologic, hematologic, renal, and hepatic status. To demonstrate efficacy of the drug as judged by status of fever, nutrition, tuberculosis lesions, and immune responses.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

July 1, 1998

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Mycobacterium Avium-Intracellulare InfectionHIV InfectionsTuberculosis, Mycobacterium Infection

Keywords

Mycobacterium tuberculosisMycobacterium InfectionsAIDS-Related Opportunistic InfectionsMycobacterium avium-intracellulare InfectionAcquired Immunodeficiency SyndromeAIDS-Related ComplexMycobacterium Infections, AtypicalThalidomide

Interventions

ThalidomideDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bellevue Hosp Ctr

New York, New York, 10016, United States

Location

Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Mycobacterium avium-intracellulare InfectionHIV InfectionsTuberculosisMycobacterium InfectionsAIDS-Related Opportunistic InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexMycobacterium Infections, Nontuberculous

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Actinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesOpportunistic InfectionsSlow Virus Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1998-07

Locations

US(2)