The Safety and Effectiveness of Clarithromycin and Rifabutin Used Alone or in Combination to Prevent...
Mycobacterium Avium-intracellulare InfectionHIV InfectionsTo compare the efficacy and safety of clarithromycin alone versus rifabutin alone versus the two drugs in combination for the prevention or delay of Mycobacterium avium Complex (MAC) bacteremia or disseminated MAC disease. To compare other parameters such as survival, toxicity, and quality of life among the three treatment arms. To obtain information on the incidence and clinical grade of targeted gynecologic conditions. Persons with advanced stages of HIV are considered to be at particular risk for developing disseminated MAC disease. The development of an effective regimen for the prevention of disseminated MAC disease may be of substantial benefit in altering the morbidity and possibly the mortality associated with this disease and its treatment.
A Phase II Safety and Efficacy Study of Clarithromycin in the Treatment of Disseminated M. Avium...
Mycobacterium Avium-intracellulare InfectionHIV InfectionsThis 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. 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 patients. Clarithromycin, a new macrolide antimicrobial agent, has demonstrated activity against MAC both in the laboratory and in animals. Clinical experience treating AIDS patients with clarithromycin for disseminated MAC is limited. However, early studies have indicated few adverse effects and some improvement in clinical symptoms scores and Karnofsky performance scores over placebo treated patients.
A Prospective, Multicenter, Single-arm MAC-PD Cohort: a NTM-NET and ESGMYC Collaborative Study
Mycobacterium Avium Complex Pulmonary DiseaseTo gain insight in the effectiveness of, adherence and adjustments to guideline-based three-drug antimycobacterial therapy in patients with Mycobacterium avium complex pulmonary disease (MAC-PD) during the first 6 months of treatment.
A Study of Rifabutin, Used Alone or With Ethambutol in the Prevention of Mycobacterium Avium Complex...
Mycobacterium Avium-Intracellulare InfectionHIV InfectionsTo optimize Mycobacterium avium Complex (MAC) prophylaxis in AIDS patients by measuring serum rifabutin levels and adjusting the dose accordingly. To combine rifabutin with ethambutol to examine the effect of combination therapy in preventing or delaying the incidence of MAC bacteremia in this patient population.
Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients...
Mycobacterium Avium-intracellulare InfectionHIV InfectionsThe primary objective of this trial is to assess the safety and the relative benefit of rifabutin monotherapy in preventing or delaying the incidence of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200, as compared to placebo, and to assess if survival is prolonged in patients who receive rifabutin prophylaxis.
Tolerance, Safety, and Activity of Rifapentine Alone and in Combination Therapy in AIDS Patients...
Mycobacterium Avium-Intracellulare InfectionHIV InfectionsTo determine the antimicrobial activity and tolerability of rifapentine alone and in combination therapy in patients with AIDS and disseminated Mycobacterium avium complex (MAC) bacteremia. To determine the pharmacokinetics of rifapentine and its metabolite, 25-desacetyl, alone and in combination therapy. To determine the pharmacokinetics of azithromycin and clarithromycin (and its 14-OH metabolite) in combination therapy.
A Randomized Controlled Prophylactic Study of Clofazimine To Prevent Mycobacterium Avium Complex...
Mycobacterium Avium-intracellulare InfectionHIV InfectionsThis study will examine the effectiveness of clofazimine in the prophylaxis of Mycobacterium avium complex infection in HIV infected individuals who are at risk to develop this untreatable opportunistic disease. In the absence of truly effective antiretroviral therapy, a potential mode of treatment of patients with HIV infection is to prevent the development of the life-threatening opportunistic infections. Current studies demonstrate a possible efficacy of clofazimine in the prophylaxis against Pneumocystis carinii pneumonia (PCP), the most common AIDS-defining opportunistic infection. Future studies will examine the potential for prophylaxis against the other opportunistic infections. This proposal hopes to define the role of prophylactic clofazimine in preventing the currently untreatable Mycobacterium avium complex infection. AMENDED: To include prophylaxis for Asymptomatic and ARC.
A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment...
Mycobacterium Avium-intracellulare InfectionHIV InfectionsTo compare the effectiveness and toxicity of two combination drug treatment programs for the treatment of disseminated Mycobacterium avium infection in HIV seropositive patients. [Per 03/06/92 amendment: to evaluate the efficacy of azithromycin when given in conjunction with either ethambutol or clofazimine as maintenance therapy.] Disseminated M. avium infection is the most common systemic bacterial infection complicating AIDS in the United States. The prognosis of patients with disseminated M. avium is extremely poor, particularly when it follows other opportunistic infections or is associated with anemia. Test tube studies and clinical data indicate that the best treatment program may include clofazimine, ethambutol, a rifamycin derivative, and ciprofloxacin. Test tube and animal studies indicate that amikacin is a bactericidal (bacteria destroying) drug that works better when used with ciprofloxacin. Its role in treatment programs is a key issue because of toxicity and because it must be administered parenterally (by injection or intravenously).
A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium...
Mycobacterium Avium-intracellulare InfectionHIV InfectionsTo 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.
Azithromycin in the Treatment of M. Avium Complex Lung Disease
Mycobacterium Avium Complex Lung DiseaseTo determine the safety and efficacy of azithromycin in the treatment of lung infection with M.avium complex and M. abscessus lung disease.