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A Comparison of Atovaquone and Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia in HIV-Infected Patients Who Cannot Take TMP/SMX Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on A Comparison of Atovaquone and Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia in HIV-Infected Patients Who Cannot Take TMP/SMX conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Comparison of Atovaquone and Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia in HIV-Infected Patients Who Cannot Take TMP/SMX Clinical research trials and A Comparison of Atovaquone and Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia in HIV-Infected Patients Who Cannot Take TMP/SMX medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like A Comparison of Atovaquone and Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia in HIV-Infected Patients Who Cannot Take TMP/SMX. A Comparison of Atovaquone and Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia in HIV-Infected Patients Who Cannot Take TMP/SMX Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a A Comparison of Atovaquone and Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia in HIV-Infected Patients Who Cannot Take TMP/SMX clinical trial. Participants frequently obtain the most expert healthcare available for their A Comparison of Atovaquone and Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia in HIV-Infected Patients Who Cannot Take TMP/SMX condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Comparison of Atovaquone and Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia in HIV-Infected Patients Who Cannot Take TMP/SMX  A Comparison of Atovaquone and Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia in HIV-Infected Patients Who Cannot Take TMP/SMX
A Comparison of Atovaquone and Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia in HIV-Infected Patients Who Cannot Take TMP/SMX
For Condition: Pneumonia, Pneumocystis carinii,HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: To assess whether high dose or low dose atovaquone suspension is more effective than aerosolized pentamidine as prophylaxis against Pneumocystis carinii pneumonia (PCP) in high-risk HIV-infected patients. To compare the safety of chronic administration of the three regimens in patients with advanced HIV disease. To determine the relationship between steady state atovaquone plasma concentrations and prophylactic efficacy against PCP.
Details: Patients are randomized to receive oral atovaquone at 1 of 2 doses once daily or aerosolized pentamidine once every 4 weeks. Treatment continues until 18 months after the last patient is enrolled. Patients are stratified into primary or secondary prophylaxis strata based on prior occurrence of a PCP episode.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Antimicrobial agents not specifically prohibited. Concurrent Treatment: Allowed: - Transfusion. Patients must have: - HIV positivity. - Prior PCP (histologically confirmed) OR documented CD4 count < 200 cells/mm3 OR constitutional symptoms such as thrush or unexplained fever (> 100 F) for 2 or more weeks. - No current or suspected active PCP, and no signs of active PCP on chest x-ray. - Prior intolerance to TMP/SMX or other trimethoprim or sulfa-containing regimens. - Life-expectancy of at least 6 months. NOTE: - Pregnant women are eligible at the discretion of the investigator. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Significant psychosis or emotional disorder that would preclude study compliance. - Severe chronic diarrhea (e.g., > five stools/day) that may negatively affect absorption of oral medication. - Unable to take oral medication or unable or unwilling to take medication with food. Concurrent Medication: Excluded: - Rifampin. - Other investigational agents except for drugs available through Treatment INDs or expanded access programs. - Medications likely to have anti-pneumocystis effect (e.g., dapsone, trimethoprim, pyrimethamine, trimetrexate, other DHFR inhibitors, sulfadiazine, sulfamethoxazole, other sulfonamides, primaquine, clindamycin, and sulfonylureas. - Corticosteroids in greater than physiologic replacement doses for more than 21 consecutive days. - Systemic therapy for CNS toxoplasmosis, Kaposi's sarcoma, lymphoma, other active malignancies, or other disease that may decrease life expectancy or confound assessment. Patients with the following prior conditions are excluded: - History of severe or intractable intolerance to atovaquone or aerosolized pentamidine. - Prior hypoglycemia, pancreatitis, arrhythmias, or severe hypotension associated with any form of pentamidine. - Prior enrollment in this protocol. Active substance abuse that would preclude study compliance.
Total Enrollment: 615
Location and Contact Information:
Bay Area AIDS Consortium
Tampa, Florida, 33609
United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666
United States
Holmes Hosp
Cincinnati, Ohio, 452670405
United States
Saint Vincent's Hosp and Med Ctr
New York City, New York, 10011
United States
Goodgame Med Group
Maitland, Florida, 32751
United States
Additional Information:
Study ID Numbers: 227B; 230
Study Start Date:
Record last reviewed: August 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002340
Other Pneumonia, Pneumocystis Carinii Studies:
1. Intensive Pharmacokinetics of the Nelfinavir Rifabutin Interaction in Patients with HIV-Related Tuberculosis Treated with a Rifabutin-Based Regimen
2. Dual Boosted- PI PK trial
3. Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen
4. Health Values and Spirituality in Veterans with HIV/AIDS
5. A Study of the Long-Term Outcomes of HIV-Positive Patients
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A Comparison of Atovaquone and Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia in HIV-Infected Patients Who Cannot Take TMP/SMX
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