The Safety and Effectiveness of Rifabutin, Combined With Clarithromycin or Azithromycin, in HIV-Infected Patients

Completed · Not applicable

Conditions studied: Mycobacterium Avium-intracellulare Infection, HIV Infections

In brief

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.

Key facts

Study ID

NCT00001023

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

91

Expected to finish

1998-07-01

Last updated by the study team

2012-10-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of Arizona / Health Science Ctr — Tucson, Arizona, United States
• Palo Alto Veterans Affairs Health Care System — Palo Alto, California, United States
• Davies Med Ctr — San Francisco, California, United States
• Denver Public Health Dept — Denver, Colorado, United States
• Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
• Tulane Univ Med School — New Orleans, Louisiana, United States
• Univ of Maryland at Baltimore / Veterans Adm — Baltimore, Maryland, United States
• Washington Univ School of Medicine — St Louis, Missouri, United States
• Univ of North Carolina School of Medicine — Chapel Hill, North Carolina, United States
• Univ of Rhode Island / Roger Williams Med Ctr — Providence, Rhode Island, United States
• Med College of Virginia / School of Pharmacy — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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