A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacteri… (NCT00001058) | Clinical Trial Compass
CompletedPhase 2
A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients With AIDS
United States, Tanzania246 participants
Plain-language summary
To compare the efficacy and safety of clarithromycin combined with rifabutin, ethambutol, or both in the treatment of disseminated Mycobacterium avium Complex (MAC) disease in persons with AIDS, including individuals who have or have not received prior MAC prophylaxis.
It is believed that effective therapy for MAC disease in patients with AIDS requires combinations of two or more antimycobacterial agents in order to overcome drug resistance and the unfavorable influence of the profound immunosuppression associated with AIDS. Data suggest that clarithromycin may have substantial activity in two- or three-drug combination regimens with clofazimine, rifamycin derivatives, ethambutol, or the 4-quinolones.
Who can participate
Age range
13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
Concurrent Medication:
Allowed:
* Antiretroviral therapy.
* Maintenance or prophylactic therapy for other opportunistic infections (with the exception of specifically excluded drugs).
* Carbamazepine or theophylline.
* Isoniazid for TB prophylaxis.
PER AMENDMENT 10/10/96:
* Therapy for acute infectious processes, other than MAC, provided that the patient is stable on the therapy.
* Fluconazole therapy for maintenance or suppression of fungal infections, providing the patient has been on a stable dose for at least 4 weeks.
PER AMENDMENT 7/02/97:
* If a patient elects to receive indinavir, ORTHO/NOVUM 1/35 is an acceptable means of birth control.
Patients must have:
* HIV infection.
* Disseminated MAC disease.
* Life expectancy of at least 8 weeks.
* Consent of parent or guardian if under 18 years of age.
NOTE:
* This protocol is approved for prisoner participation.
Prior Medication:
Allowed:
PER AMENDMENT 10/10/96:
* Therapy for acute infectious processes, other than MAC, prior to study entry.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Active mycobacterial infection other than MAC that requires treatment, with the exception of isoniazid used solely for TB prophylaxis.
Concurrent Medication:
Excluded:
* Other antimycobacterial drugs (with the exception of isoniazid for TB prophylaxis).
* Other investigational drugs unless approved by protocol chair.
PER AMENDMENT 7/2/97:
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00001058
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)