Clinical Trials Logo
  1. Home
  2. HIV Infections
  3. NCT00002140
  4. Details
NCT00002140 Clinical Trial

A Randomized, Double-Blind, Comparative Study of Azithromycin Versus Clarithromycin in Combination With Ethambutol for the Treatment of Disseminated Mycobacterium Avium Complex (MAC) Infection in AIDs Patients

HIV Infections Clinical Trial

Official title:
A Randomized, Double-Blind, Comparative Study of Azithromycin Versus Clarithromycin in Combination With Ethambutol for the Treatment of Disseminated Mycobacterium Avium Complex (MAC) Infection in AIDs Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002140
Other study ID # 226B
Secondary ID 066-189189/189B
Status Completed
Phase Phase 3
First received November 2, 1999
Last updated June 23, 2005

Study information
Verified date July 1998
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of two different doses of azithromycin in combination with ethambutol for the treatment of patients with Mycobacterium avium complex (MAC) infection, and to determine whether an azithromycin-containing regimen is at least as safe and effective as the same regimen containing clarithromycin..

Description:

Patients are randomized to receive azithromycin at one of two doses in combination with ethambutol or clarithromycin in combination with ethambutol for 24 weeks, after which they are evaluated for entry into a maintenance phase of treatment. Clinical, microbiologic, and safety assessments are performed every 3 weeks for the first 12 weeks, then monthly for the remaining 12 weeks.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility Inclusion Criteria

Patients must have:

- HIV seropositivity.

- Disseminated MAC.

- No MAC therapy between time of last positive blood culture draw and study entry (single-agent prophylaxis allowed).

- Life expectancy of at least 2 months.

- Consent of parent or guardian if below legal age of consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

- Known hypersensitivity to macrolide antibiotics (erythromycin, azithromycin, or clarithromycin) or ethambutol.

- Inability to take oral medications.

- Condition likely to interfere with drug absorption (e.g., gastrectomy, malabsorption syndromes).

Concurrent Medication:

Excluded:

- Another investigational drug started in the week prior to study entry.

Prior Medication:

Excluded:

- MAC therapy between time of last positive blood culture draw and study entry (although single-agent prophylaxis is allowed).

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ethambutol hydrochloride

• Clarithromycin

• Azithromycin

Locations
Country Name City State
United States West Paces Clinical Research Inc Atlanta Georgia
United States Austin Infectious Disease Consultants Austin Texas
United States Central Texas Med Foundation Austin Texas
United States East Bay AIDS Ctr Berkeley California
United States Dr Neel French / Louis A Weiss Memorial Hosp Chicago Illinois
United States Northwestern Univ Med School Chicago Illinois
United States Univ of Texas Southwestern Med Ctr of Dallas Dallas Texas
United States Duke Univ Med Ctr Durham North Carolina
United States Pfizer Central Research Groton Connecticut
United States Hampton Roads Med Specialists Hampton Virginia
United States Dr Gary Brewton Houston Texas
United States Thomas Street Clinic / Baylor College of Medicine Houston Texas
United States Trinity Lutheran Hosp / Infectious Disease Clinic Kansas City Missouri
United States Med Service Miami Florida
United States Dr Milton Estes Mill Valley California
United States Oschner Clinic New Orleans Louisiana
United States Infectious Disease Med Group / Adult Immunology Clinic Oakland California
United States UCI Med Ctr Orange California
United States Kaiser Permanente Med Ctr San Francisco California
United States Santa Clara Valley Med Ctr San Jose California
United States Dr Robert Wallace St Petersburg Florida
United States Bay Area AIDS Consortium Tampa Florida
United States Georgetown Univ Med Ctr Washington District of Columbia
United States Whitman - Walker Clinic Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dunne M, Fessel J, Kumar P, Dickenson G, Keiser P, Boulos M, Mogyros M, White Jr AC, Cahn P, O'Connor M, Lewi D, Green S, Tilles J, Hicks C, Bissett J, Schneider MM, Benner R. A randomized, double-blind trial comparing azithromycin and clarithromycin in the treatment of disseminated Mycobacterium avium infection in patients with human immunodeficiency virus. Clin Infect Dis. 2000 Nov;31(5):1245-52. Epub 2000 Nov 6. Erratum in: Clin Infect Dis 2001 May 1;32(9):1386. — View Citation

See also
  Status Clinical Trial Phase
Completed NCT05454514 - Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS N/A
Completed NCT03760458 - The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age Phase 1/Phase 2
Completed NCT03067285 - A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study Phase 4
Completed NCT03141918 - Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS N/A
Recruiting NCT04579146 - Coronary Artery Disease (CAD) in Patients HIV-infected
Completed NCT06212531 - Papuan Indigenous Model of Male Circumcision N/A
Active, not recruiting NCT03256422 - Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients Phase 3
Completed NCT03256435 - Retention in PrEP Care for African American MSM in Mississippi N/A
Completed NCT00517803 - Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies N/A
Active, not recruiting NCT03572335 - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Completed NCT04165200 - Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV N/A
Recruiting NCT03854630 - Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection Phase 4
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT02234882 - Study on Pharmacokinetics Phase 1
Completed NCT01618305 - Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission Phase 4
Recruiting NCT05043129 - Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
Not yet recruiting NCT05536466 - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine N/A
Recruiting NCT04985760 - Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy Phase 1
Completed NCT05916989 - Stimulant Use and Methylation in HIV
Terminated NCT02116660 - Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) Phase 2