|
A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients Clinical research trials and A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients. A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients clinical trial. Subjects frequently obtain the most expert healthcare possible for their A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients  A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients
A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients
For Condition: Mycobacterium avium-intracellulare Infection,HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: This study is designed to find out whether HIV-positive patients whose immune systems have improved after receiving anti-HIV treatment should take azithromycin to prevent Mycobacterium avium complex (MAC) disease. This study also examines the possibility of putting off MAC prevention treatment in patients who respond well to anti-HIV drug therapy. Azithromycin is approved for the prevention of MAC disease in people with HIV and low CD4 cell counts. However, some people who have taken azithromycin have been found to carry antibiotic-resistant bacteria (germs that can grow despite the presence of drugs used to kill them). It is not known whether the risks associated with taking azithromycin outweigh the risk of getting MAC disease.
Details: The need for MAC prophylaxis in advanced HIV disease is recognized. Prophylactic therapy is complicated, however, due to drug toxicity, potential drug interactions, patient noncompliance with multiagent regimens, microbial drug resistance, and high treatment costs. This study assesses the feasibility of deferring MAC prophylaxis in patients whose CD4+ cell counts rebound in response to antiretroviral therapy. In this double-blind, placebo-controlled trial, patients are randomized to receive azithromycin weekly or matching placebo. Patients are switched to open-label azithromycin if they have an average CD4+ cell count less than 50 cells/mm3 on 2 consecutive counts obtained at least 48 hours apart (preferably no more than 60 days). [AS PER AMENDMENT 10/23/97: SUBSTUDY CPCRA 054: A subset of participants of CPCRA 048 have oropharyngeal swabs taken at baseline and 4 months after randomization. Antibiotic susceptibility tests are then performed on isolates of S. pneumoniae.] [AS PER AMENDMENT 9/3/99: Participants in protocol version 3.0 are followed for data collection purposes every 4 months for 18 months until January 31, 2001. Data collection includes CD4 cell counts, viral RNA measurements, macrolide susceptibility in MAC isolates, and antibiotic susceptibility of isolates from bacterial pneumonia episodes.]
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria You may be eligible for this study if you: - Are HIV-positive. - Have 2 CD4 counts over 100 cells/mm3 at least 30 days apart. - Have a history of CD4 counts under 50 cells/mm3. - Are at least 13 years old (need consent if under 18). - Are in reasonably good health. - Are expected to live for at least 6 months. - Are receiving anti-HIV medications at study entry. Exclusion Criteria You will not be eligible for this study if you: - Have/had MAC disease. - Have been unable to take azithromycin in the past. - Are on any medications that act against MAC.
Total Enrollment: 850
Location and Contact Information:
Overall Study Official:
WafaaEl-Sadr, Study Chair,
The Research and Education Group
Portland, Oregon, 97210
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 303081962
United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112
United States
LSMUC / Lions Clinic
New Orleans, Louisiana, 701122699
United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
United States
Henry Ford Hosp
Detroit, Michigan, 48202
United States
Community Consortium / Jon Kaiser Wellness Ctr
San Francisco, California, 941102028
United States
Partners in Research / New Mexico
Albuquerque, New Mexico, 87131
United States
Harlem AIDS Treatment Grp / Harlem Hosp Ctr
New York City, New York, 10037
United States
Community Consortium / UCSF
San Francisco, California, 94110
United States
Saint Joseph's Hosp
Philadelphia, Pennsylvania, 19107
United States
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, 08103
United States
Catherine McAuley Health Ctr
Detroit, Michigan, 48201
United States
Richmond AIDS Consortium / Div of Infect Diseases
Richmond, Virginia, 232980049
United States
Washington Reg AIDS Prog / Dept of Infect Dis
Washington D.C., District of Columbia, 20422
United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 802044507
United States
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
Detroit, Michigan, 48201
United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
United States
Additional Information:
Study ID Numbers: CPCRA 048;
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000947
Other Hiv Infections Studies:
1. Safety of and Immune Response to a Combination HIV Vaccine Regimen in HIV Uninfected Adults
2. Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine or Dideoxyinosine in HIV Positive, Asymptomatic and Symptomatic Individuals
3. A Study of Foscarnet Plus Ganciclovir in the Treatment of Cytomegalovirus of the Eye in Patients with AIDS Who Have Already Been Treated with Ganciclovir
4. The Effect of Teaching HIV-Infected Patients about HIV and Treatment
5. A Study to Evaluate the Use of Memantine In Combination with Anti-HIV Drugs to Treat AIDS Dementia Complex (ADC)
Related Studies:
Other HIV Infections Clinical Trials
Other New Mexico Clinical Trials
Other Albuquerque Clinical Trials
A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients
|
|
|
|
|
|
|
|
