Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in HIV Positive Patients With CD4 Counts = or < 200: Treatment IND Study

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002080
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 2003
  Purpose

Primary: To provide rifabutin to HIV positive patients in an attempt to prevent or delay Mycobacterium avium Complex (MAC) infection by a daily dose of rifabutin.

Secondary: To further characterize the safety of rifabutin monotherapy in preventing or delaying MAC bacteremia in HIV positive patients with CD4 counts = or < 200.


Condition Intervention
Mycobacterium Avium-intracellulare Infection
HIV Infections
Drug: Rifabutin

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in HIV Positive Patients With CD4 Counts = or < 200: Treatment IND Study

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Any medication with the exception of other investigational drugs not available under a treatment IND, expanded access, or parallel track program.

Patients must have:

  • Confirmed HIV infection.
  • CD4 cell counts <= 200 cells/mm3.
  • No evidence of disseminated MAC disease.
  • Informed consent of parent or guardian if 12 to < 18 years of age.

NOTE:

  • Pregnant females may be eligible. There are no studies of the safety or efficacy of rifabutin in pregnant women. Rifabutin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In addition, a risk/benefit decision should consider the likelihood of a woman's developing MAC if she does not receive prophylaxis. The risk of developing MAC rises substantially for women with CD4 counts less than 100, although it can also develop in women with higher CD4 counts. Women of reproductive potential who are not pregnant must use contraception. They are encouraged to use means other than oral contraceptives.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • Known hypersensitivity to rifabutin, rifampin, or other rifamycins.
  • Current infection due to MAC or other mycobacterial disease, or complaints consistent with tuberculosis.

Concurrent Medication:

Excluded:

  • Other investigational drugs with the exception of those available under a treatment IND, expanded access, or parallel track program. (Licensed products prescribed for unlabeled indications are not considered investigational.)

Patients with the following prior conditions are excluded:

Prior infection due to MAC or other mycobacterial disease or complaints consistent with tuberculosis.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002080

Locations
United States, Pennsylvania
PACT
Saint Davids, Pennsylvania, United States, 19087
Sponsors and Collaborators
Pharmacia
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00002080     History of Changes
Other Study ID Numbers: 109A, 087085-999
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Rifabutin
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Mycobacterium avium Complex
Bacteremia

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
HIV Seropositivity
Mycobacterium Infections
Bacteremia
Mycobacterium avium-intracellulare Infection
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Mycobacterium Infections, Nontuberculous
Rifabutin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014