NCT00002058

Brief Summary

This study will examine the effectiveness of clofazimine in the prophylaxis of Mycobacterium avium complex infection in HIV infected individuals who are at risk to develop this untreatable opportunistic disease. In the absence of truly effective antiretroviral therapy, a potential mode of treatment of patients with HIV infection is to prevent the development of the life-threatening opportunistic infections. Current studies demonstrate a possible efficacy of clofazimine in the prophylaxis against Pneumocystis carinii pneumonia (PCP), the most common AIDS-defining opportunistic infection. Future studies will examine the potential for prophylaxis against the other opportunistic infections. This proposal hopes to define the role of prophylactic clofazimine in preventing the currently untreatable Mycobacterium avium complex infection. AMENDED: To include prophylaxis for Asymptomatic and ARC.

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

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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

December 1, 1990

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Mycobacterium Avium-intracellulare InfectionHIV Infections

Keywords

AIDS-Related Opportunistic InfectionsMycobacterium avium-intracellulare InfectionClofazimineAcquired Immunodeficiency Syndrome

Interventions

ClofazimineDRUG

Eligibility Criteria

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

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Pneumocystis prophylaxis.
  • Antiretroviral therapy, or other experimental protocols.
  • Antipyretics and analgesics as per the treating physician.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following are excluded:
  • Unexplained fever.
  • Night sweats.
  • Unexplained anemia with hemoglobin \< 10 g percent or hematocrit less than 30 percent.
  • Hepatic transaminase elevations or total bilirubin values of \> 3 times normal.
  • Long-term (over 2 weeks) treatment with any drug with known significant anti-Mycobacterium avium complex (MAC) activity including isoniazid, ethambutol, rifampin, raffia, PAS, PZA, amikacin, streptomycin, ethionamide, viomycin, cycloserine, capreomycin, ciprofloxacin, imipenem, rifapentine, gentamicin, or penicillin.
  • Patients with the following are excluded:
  • Known hypersensitivity to clofazimine.
  • Mycobacterium avium complex (MAC) infection diagnosis at any site (except isolation from stool in asymptomatic patient).
  • Any of the following symptoms at the time of study entry:
  • Unexplained fever.
  • Night sweats.
  • Unexplained anemia with hemoglobin \< 10 percent or hematocrit less than 30 percent.
  • Hepatic transaminase elevations or total bilirubin values of \> 3 times normal.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Keith Med Group

Los Angeles, California, 90048, United States

Location

San Francisco Gen Hosp

San Francisco, California, 941102859, United States

Location

Related Publications (2)

  • Gustavson LE, Fukuda EK, Rubio FA, Dunton AW. A pilot study of the bioavailability and pharmacokinetics of 2',3'-dideoxycytidine in patients with AIDS or AIDS-related complex. J Acquir Immune Defic Syndr (1988). 1990;3(1):28-31.

    PMID: 2152803BACKGROUND

  • Abrams DI, Mitchell TF, Child CC, Shiboski SC, Brosgart CL, Mass MM. Clofazimine as prophylaxis for disseminated Mycobacterium avium complex infection in AIDS. J Infect Dis. 1993 Jun;167(6):1459-63. doi: 10.1093/infdis/167.6.1459.

    PMID: 8501340BACKGROUND

MeSH Terms

Conditions

Mycobacterium avium-intracellulare InfectionHIV InfectionsAIDS-Related Opportunistic InfectionsAcquired Immunodeficiency Syndrome

Interventions

Clofazimine

Condition Hierarchy (Ancestors)

Mycobacterium Infections, NontuberculousMycobacterium InfectionsActinomycetales 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)

PhenazinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1990-12

Locations

US(2)