Status:
COMPLETED
A Phase II Safety and Efficacy Study of Clarithromycin in the Treatment of Disseminated M. Avium Complex (MAC) Infections in Patients With AIDS
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Abbott
Conditions:
Mycobacterium Avium-intracellulare Infection
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
PHASE2
Brief Summary
This study is designed to evaluate the efficacy and safety of clarithromycin given orally at 1 of 3 doses to treat disseminated Mycobacterium avium complex infections (MAC) in patients with AIDS. Myc...
Detailed Description
Mycobacterium avium complex (MAC) is thought to be the most common disseminated bacterial opportunistic infection in AIDS, with clinical prevalence estimates ranging from 15 to 50 percent of all AIDS ...
Eligibility Criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
- Didanosine (ddI).
- Dideoxycytidine (ddC).
- Zidovudine (AZT).
- Acetaminophen.
- Acyclovir.
- Fluconazole.
- Erythropoietin (EPO).
- Systemic Pneumocystis carinii pneumonia (PCP) prophylaxis (aerosolized or oral pentamidine, trimethoprim / sulfamethoxazole, or dapsone).
- Maintenance ganciclovir therapy (permitted only if dose and clinical and laboratory parameters have been stable for at least 4 weeks prior to study entry).
- Maintenance treatment for other opportunistic infections if the dose and clinical and laboratory parameters have been stable for 4 weeks prior to study entry.
Patients must have:
- Positive results for HIV by ELISA confirmed by another method.
- Positive blood culture for Mycobacterium avium complex within 2 months of study entry and clinical symptoms of MAC infection.
- Discontinued all mycobacterial drugs (approved and investigational) for at least 4 weeks prior to the start of drug therapy (with the exception of isoniazid prophylaxis which should be discontinued at Study Day minus 14 to Study Day minus 7
- Given written informed consent to participate in the trial.
- Met the listed laboratory parameters in the pre-treatment visit.
Prior Medication:
Allowed:
- Didanosine (ddI).
- Deoxycytidine (ddC).
- Zidovudine (AZT).
- Acetaminophen.
- Acyclovir.
- Fluconazole.
- Erythropoietin (EPO).
- Systemic Pneumocystis carinii pneumonia (PCP) prophylaxis (aerosolized or oral pentamidine, dapsone, trimethoprim / sulfamethoxazole).
- Maintenance ganciclovir therapy (permitted only if dose and clinical and laboratory parameters have been stable for at least 4 weeks prior to study entry).
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Active opportunistic infections. Maintenance treatment for other opportunistic infections will be permitted if the dose and clinical and laboratory parameters have been stable for 4 weeks prior to study entry.
Concurrent Medication:
Excluded:
- Aminoglycosides.
- Ansamycin (rifabutin).
- Quinolones.
- Other macrolides.
- Clofazimine.
- Cytotoxic chemotherapy.
- Rifampin.
- Ethambutol.
- Immunomodulators (except alpha interferon).
- Investigational drugs (except ddI, ddC, and erythropoietin).
Patients with the following are excluded:
- History of allergy to macrolide antimicrobials.
- Currently on active therapy with any anti-mycobacterial drugs listed in Exclusion Prior Medications.
- Currently on active therapy with carbamazepine or theophylline, unless the investigator agrees to carefully monitor blood levels.
- Inability to comply with the protocol or judged to be near imminent death by the investigator.
- Active opportunistic infections.
- Requiring any of the excluded concomitant medications.
Prior Medication:
Excluded for at least 4 weeks prior to study entry:
- All anti-mycobacterial drugs (approved and investigational) with the exception of isoniazid prophylaxis, which should be discontinued at Study Day minus 14 to minus 7.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00000644
Last Update
February 25 2011
Active Locations (3)
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1
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
2
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
3
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287