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A Comparative Study of a Combination of Zidovudine, Didanosine, and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on A Comparative Study of a Combination of Zidovudine, Didanosine, and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Comparative Study of a Combination of Zidovudine, Didanosine, and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine Clinical research trials and A Comparative Study of a Combination of Zidovudine, Didanosine, and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine healthcare trials happen in a lot of of localities across 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 generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as A Comparative Study of a Combination of Zidovudine, Didanosine, and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine. A Comparative Study of a Combination of Zidovudine, Didanosine, and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a A Comparative Study of a Combination of Zidovudine, Didanosine, and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine clinical trial. Human subjects often receive the most effective healthcare possible for their A Comparative Study of a Combination of Zidovudine, Didanosine, and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Comparative Study of a Combination of Zidovudine, Didanosine, and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine  A Comparative Study of a Combination of Zidovudine, Didanosine, and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine
A Comparative Study of a Combination of Zidovudine, Didanosine, and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Bristol-Myers Squibb,Glaxo Wellcome
Synopsis: To assess the safety and toxicity of zidovudine (AZT)/didanosine (ddI) versus AZT/ddI combined with nevirapine in HIV-infected patients, and to obtain preliminary anti-HIV activity data using immunologic and virologic markers. Previous in vitro studies suggest that HIV that has already developed resistance to AZT and ddI is less able to develop resistance to nevirapine, a non-nucleoside reverse transcriptase inhibitor. Thus, convergent combination therapy with these three drugs in HIV-infected patients may prove more effective.
Details: Previous in vitro studies suggest that HIV that has already developed resistance to AZT and ddI is less able to develop resistance to nevirapine, a non-nucleoside reverse transcriptase inhibitor. Thus, convergent combination therapy with these three drugs in HIV-infected patients may prove more effective. Patients are randomized to receive AZT/ddI plus either nevirapine or placebo daily for 48 weeks, with possible extension for at least 12 weeks. At eight participating sites, ACTG 808 and 809 will be conducted as virologic and pharmacokinetic substudies.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Pharmacokinetics Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Required: - PCP prophylaxis for patients with CD4 count < 200 cells/mm3 or a prior history of PCP. Allowed: - Trimethoprim with sulfamethoxazole or dapsone, intravenous pentamidine, atovaquone, primaquine-clindamycin or trimetrexate for acute PCP. - Topical antifungals, clotrimazole, ketoconazole, fluconazole, and amphotericin B for treatment of mucosal and esophageal candidiasis. - Prophylaxis or therapy for opportunistic infections, as indicated, with other medications such as itraconazole, isoniazid, pyrazinamide, clofazimine, clarithromycin, azithromycin, ethambutol, amikacin, ciprofloxacin, ofloxacin, pyrimethamine, sulfadiazine, and clindamycin. - Maintenance therapy for opportunistic infections as long as patients have been on a stable dosage regimen for 1 month prior to study entry. - Ganciclovir for CMV retinitis or gastrointestinal disease as long as patients have been on a stable dose for at least 1 month prior to study entry with no grade 3 or 4 neutropenia or dependence on G-CSF. - Acyclovir (<= 1000 mg/day) for maintenance of herpes simplex virus infections. - Erythropoietin or G-CSF if clinically indicated. - Antibiotics for bacterial infections unless specifically excluded. - Rifampin or rifabutin. - Symptomatic treatments such as antipyretics, analgesics, and antiemetics. Concurrent Treatment: Allowed: - Local radiation therapy. Prior Medication: Required: - At least 6 months of prior cumulative nucleoside therapy with AZT, ddI, or ddC, given as monotherapy or in combination. Patients must have: - Prior or current documentation of HIV seropositivity by ELISA confirmed by Western blot, positive HIV antigen, or positive HIV culture, or a second antibody test by a method other than ELISA. - CD4 count <= 350 cells/mm3. - Prior cumulative nucleoside therapy of >= 6 months. - Consent of parent or guardian if less than 18 years of age. Exclusion Criteria Concurrent Medication: Excluded: - Antiretroviral therapies other than study medications. - Systemic corticosteroids given consecutively for > 21 days. - Induction or maintenance with foscarnet. - Systemic cytotoxic chemotherapy for a malignancy. - Erythromycin. - Coumadin/warfarin. - Phenytoin or phenobarbital. - Amoxicillin/clavulanate acid (Augmentin) or ticarcillin/clavulanate acid (Timentin). Patients with the following prior conditions are excluded: - History of pancreatitis. - History of intolerance to 500 or 600 mg/day AZT or to 400 mg/day ddI tablets or 500 mg/day ddI sachets. - History of grade 2 or worse peripheral neuropathy. Prior Medication: Excluded at any time: Prior non-nucleoside reverse transcriptase inhibitors (NVP; L697,611; TIBO; atevirdine). Excluded within 14 days prior to study entry: - Acute treatment for a serious infection or any opportunistic infection. - Biologic response modifiers such as interferon and IL-2. - Erythromycin. - Coumadin/warfarin. - Phenytoin or phenobarbital. - Ticarcillin/clavulanate acid (Timentin) or amoxicillin/clavulanate acid (Augmentin).
Total Enrollment: 400
Location and Contact Information:
Overall Study Official:
D'AquilaR, Study Chair,
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
North Central Bronx Hosp / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Hennepin County Med Clinic
Minneapolis, Minnesota, 55415
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Wake County Dept of Health
Raleigh, North Carolina, 27610
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130
United States
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, 94609
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Samaritan Village Inc / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Girard Med Ctr
Philadelphia, Pennsylvania, 191046073
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Montefiore Family Health Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
St Paul Ramsey Med Ctr
St. Paul, Minnesota, 55101
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Comprehensive Health Care Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Saint Clare's Hosp and Health Ctr
New York City, New York, 10019
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, 946021018
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Moses H Cone Memorial Hosp
Greensboro, North Carolina, 27401
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Carolinas Med Ctr
Charlotte, North Carolina, 28203
United States
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, 191075098
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Univ of Iowa Hosp and Clinic
Iowa City, Iowa, 52242
United States
Additional Information:
Study ID Numbers: ACTG 241;
Study Start Date:
Record last reviewed: December 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000770
Other Hiv Infections Studies:
1. Open-Label "Compassionate" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients
2. An Investigational Combination Vaccine Given to People Who Are Not Infected with HIV
3. A Registry of Tuberculosis Cases in the CPCRA
4. Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected with HIV
5. A Phase III Randomized Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC/ZDV/1592U89 and 3TC/ZDV/IDV in HIV-1 Infected Antiretroviral Therapy-Naive Subjects.
Related Studies:
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A Comparative Study of a Combination of Zidovudine, Didanosine, and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine
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