The Safety and Effectiveness of Clarithromycin in the Prevention of Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients
This study has been completed.
Sponsor:
Abbott
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00002336
First received: November 2, 1999
Last updated: February 19, 2009
Last verified: February 2009
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Purpose
To determine whether clarithromycin is safe and effective in preventing disseminated Mycobacterium avium Complex in HIV-infected patients with CD4 counts <= 100 cells/mm3.
| Condition | Intervention |
|---|---|
|
Mycobacterium Avium-Intracellular Infection HIV Infections |
Drug: Clarithromycin |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Prospective, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study of the Safety and Efficacy of Clarithromycin for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients With CD4 Counts <= 100 Cells/mm3 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Clarithromycin
U.S. FDA Resources
Further study details as provided by Abbott:
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
Patients must have:
- HIV infection.
- CD4 count <= 100 cells/mm3.
- No evidence of MAC.
- Life expectancy of at least 6 months.
Exclusion Criteria
Concurrent Medication:
Excluded:
- Certain restricted drugs (details not available).
Patients with the following prior conditions are excluded:
History of allergy or hypersensitivity to macrolides. Active substance abuse or other conditions that would affect study compliance.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002336
Locations
| United States, Arizona | |
| Univ of Arizona / Health Science Ctr | |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| California Med Research Group | |
| Fresno, California, United States, 93726 | |
| HIV Research Group | |
| San Diego, California, United States, 92102 | |
| Saint Francis Mem Hosp | |
| San Francisco, California, United States, 94109 | |
| Kaiser Permanente Med Ctr | |
| San Francisco, California, United States, 94115 | |
| Santa Clara Valley Med Ctr | |
| San Jose, California, United States, 951282699 | |
| United States, Florida | |
| TheraFirst Med Ctrs Inc | |
| Fort Lauderdale, Florida, United States, 33308 | |
| Dr Nelson Zide | |
| Hollywood, Florida, United States, 33021 | |
| Infectious Disease Research Institute Inc | |
| Tampa, Florida, United States, 33614 | |
| United States, Indiana | |
| Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, New York | |
| Saint Vincent's Hosp and Med Ctr | |
| New York, New York, United States, 10011 | |
| SUNY / Health Sciences Ctr at Syracuse | |
| Syracuse, New York, United States, 13210 | |
| New York Med College / Westchester County Med Ctr | |
| Valhalla, New York, United States, 10595 | |
| United States, North Carolina | |
| Nalle Clinic | |
| Charlotte, North Carolina, United States, 28207 | |
| United States, Oregon | |
| Westover Heights Clinic | |
| Portland, Oregon, United States, 97210 | |
| United States, Tennessee | |
| Univ of Tennessee | |
| Memphis, Tennessee, United States, 38163 | |
| Vanderbilt Univ | |
| Nashville, Tennessee, United States, 37212 | |
| United States, Texas | |
| Univ of Texas Southwestern Med Ctr of Dallas | |
| Dallas, Texas, United States, 75235 | |
| Houston Veterans Administration Med Ctr | |
| Houston, Texas, United States, 77030 | |
| Audie L Murphy Veterans Administration Hosp | |
| San Antonio, Texas, United States, 78284 | |
| United States, Virginia | |
| Salem Veterans Administration Med Ctr | |
| Salem, Virginia, United States, 24153 | |
| United States, Washington | |
| Dr Alan D Tice / Infections Ltd | |
| Tacoma, Washington, United States, 98405 | |
Sponsors and Collaborators
Abbott
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00002336 History of Changes |
| Other Study ID Numbers: | 124A, M91-561 |
| Study First Received: | November 2, 1999 |
| Last Updated: | February 19, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Abbott:
|
Mycobacterium avium-intracellular Infection Acquired Immunodeficiency Syndrome Clarithromycin |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Mycobacterium Infections 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 Mycobacterium Infections, Atypical Clarithromycin Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 14, 2013
