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Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of Rifabutin, Combined with Clarithromycin or Azithromycin, in HIV-Infected Patients  The Safety and Effectiveness of Rifabutin, Combined with Clarithromycin or Azithromycin, in HIV-Infected Patients
The Safety and Effectiveness of Rifabutin, Combined with Clarithromycin or Azithromycin, in HIV-Infected Patients
For Condition: Mycobacterium avium-intracellulare Infection,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: PER 03/10/94 AMENDMENT: PART B. To determine whether there is an effect on plasma drug levels of azithromycin and rifabutin as measured by changes in the plasma concentration-time curve (AUC) when these drugs are taken concomitantly. ORIGINAL PRIMARY: To gain preliminary information about the safety and tolerance of clarithromycin and azithromycin in combination with rifabutin (three potential agents against Mycobacterium avium-intracellulare) in HIV-infected patients with CD4 counts < 200 cells/mm3. ORIGINAL SECONDARY: To determine whether there is an effect on the pharmacokinetics of the macrolide antibiotics or rifabutin when these drugs are taken concomitantly. To monitor the effect of rifabutin therapy on dapsone serum levels in patients taking dapsone for PCP prophylaxis. To monitor the effect of macrolide/rifabutin combination therapies on AZT or ddI serum levels. Two new macrolide antibiotics, clarithromycin and azithromycin, and rifabutin (a rifamycin derivative) have all demonstrated in vitro and in vivo activity against Mycobacterium avium-intracellulare, a common systemic bacterial infection complicating AIDS. Further information is needed, however, regarding the clinical and pharmacokinetic interaction of these drugs used in combination.
Details: Two new macrolide antibiotics, clarithromycin and azithromycin, and rifabutin (a rifamycin derivative) have all demonstrated in vitro and in vivo activity against Mycobacterium avium-intracellulare, a common systemic bacterial infection complicating AIDS. Further information is needed, however, regarding the clinical and pharmacokinetic interaction of these drugs used in combination. AMENDED 03/10/94 (Part B): Approximately 38 HIV-infected or uninfected subjects are randomized to receive azithromycin or rifabutin (Groups 3 and 4) daily for 14 days, followed by a combination regimen of both drugs for 4 additional weeks. Patients are followed weekly. Pharmacokinetic sampling will be performed on days 14, 15, and 42-45. ORIGINAL: Sixty-eight patients are randomly assigned to one of four groups (17 patients per group). They receive either clarithromycin or azithromycin in combination with rifabutin on one of two different dosing schedules. Patients receive medication for 6 weeks and undergo follow-up weekly during drug administration and at week 8.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Primary or secondary PCP prophylaxis with TMP/SMX, dapsone, or aerosolized pentamidine. - Any approved therapy for antiretroviral treatment, or antiretroviral therapy available through FDA-sanctioned treatment IND or treatment protocol. Patients must have: AMENDED (PART B): - Either HIV infection OR no HIV infection. - CD4 count unspecified. ORIGINAL: - Documented HIV infection. - CD4 count < 200 cells/mm3 within 90 days prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: - Known Mycobacterium avium-intracellulare (MAI) bacteremia or presence of a clinical syndrome compatible with MAI (i.e., fevers, weight loss, elevated LDH and alkaline phosphatase). - Fever = or > 38.5 deg C (100.4 deg F) within 7 days prior to study entry. Concurrent Medication: Excluded: - Acute or chronic use of phenobarbital, carbamazepine, rifampin, dilantin, fluconazole, itraconazole, ketoconazole, ciprofloxacin, beta-blockers, or clarithromycin. - Oral contraceptives. - Acute therapy for an AIDS-related opportunistic infection or malignancy, or other acute medical illness, or infection. - Maintenance therapy for CMV, cryptococcal meningitis, or toxoplasmosis. - Cytotoxic chemotherapy. Patients with the following prior conditions are excluded: - History of intolerance or hypersensitivity to study drugs, other macrolide antibiotics, or rifampin. - Three or more loose bowel movements per day within 3 months prior to study entry. - Unintentional weight loss >= 5 percent of body weight within 3 months prior to study entry. Prior Medication: Excluded: - Rifabutin within 30 days prior to study entry. - Clarithromycin or azithromycin within 14 days prior to study entry. - Acute therapy for an AIDS-related opportunistic infection or malignancy, or other acute medical illness, or infection within 28 days prior to study entry. Prior Treatment: Excluded: - Blood transfusions within 1 month prior to study entry.
Total Enrollment: 91
Location and Contact Information:
Overall Study Official:
RHafner, Study Chair,
Med College of Virginia / School of Pharmacy
Richmond, Virginia, 232980533
United States
Denver Public Health Dept
Denver, Colorado, 802044507
United States
Davies Med Ctr
San Francisco, California, 94114
United States
Tulane Univ Med School
New Orleans, Louisiana, 701122699
United States
Palo Alto Veterans Affairs Health Care System
Palo Alto, California, 94304
United States
Washington Univ School of Medicine
St. Louis, Missouri, 63108
United States
Univ of Maryland at Baltimore / Veterans Adm
Baltimore, Maryland, 21201
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Univ of Rhode Island / Roger Williams Med Ctr
Providence, Rhode Island, 02908
United States
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, 275997215
United States
Univ of Arizona / Health Science Ctr
Tucson, Arizona, 85724
United States
Additional Information:
Study ID Numbers: DATRI 001;
Study Start Date:
Record last reviewed: October 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001023
Other Mycobacterium Avium-Intracellulare Infection Studies:
1. A Study of HIV-Disease Development in Aging
2. Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy
3. A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined with MF59 in HIV-1 Uninfected Adult Volunteers
4. The Effectiveness of Ritonavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients
5. A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis
Related Studies:
Other Mycobacterium avium-intracellulare Infection Clinical Trials
Other Missouri Clinical Trials
Other St. Louis Clinical Trials
The Safety and Effectiveness of Rifabutin, Combined with Clarithromycin or Azithromycin, in HIV-Infected Patients
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