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Comparison of GW433908/Ritonavir to Nelfinavir When Used with Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Comparison of GW433908/Ritonavir to Nelfinavir When Used with Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Comparison of GW433908/Ritonavir to Nelfinavir When Used with Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs Clinical research trials and Comparison of GW433908/Ritonavir to Nelfinavir When Used with Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs healthcare trials take place in many of cities 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 evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Comparison of GW433908/Ritonavir to Nelfinavir When Used with Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs. Comparison of GW433908/Ritonavir to Nelfinavir When Used with Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Comparison of GW433908/Ritonavir to Nelfinavir When Used with Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Comparison of GW433908/Ritonavir to Nelfinavir When Used with Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Comparison of GW433908/Ritonavir to Nelfinavir When Used with Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs  Comparison of GW433908/Ritonavir to Nelfinavir When Used with Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs
Comparison of GW433908/Ritonavir to Nelfinavir When Used with Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Glaxo Wellcome ,
Synopsis: The purpose of this study is to compare virus response to GW433908/ritonavir (RTV) to viral response to nelfinavir (NFV) when used with abacavir (ABC)/lamivudine (3TC) in patients that have not taken antiretroviral (ART) drugs.
Details: Patients are randomized to 1 of 2 treatment arms. One arm is treated with GW433908/RTV plus ABC and 3TC. The other is treated with NFV plus ABC and 3TC. Each group is treated for 48 weeks. The following are compared in the 2 arms: 1) magnitude and durability of antiviral response; 2) safety, tolerance, and antiviral response after 24 and 48 weeks of therapy; 3) time to treatment failure; 4) immunologic response; 5) occurrence of events related to metabolic abnormalities; and 6) development of viral resistance in a subset of patients following treatment. Also studied are: 1) steady-state plasma drug trough concentrations; 2) demographic, virologic, immunologic, pharmacologic, and adherence factors that may be associated with treatment outcome; 3) patient adherence to the drug regimens; 4) study medication utilization; and 5) resource utilization.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are at least 13 years old (consent of parent or guardian needed if under 18). - Agree to use a proven barrier method of birth control (e.g., spermicide plus condom) during the study period (hormonal birth control will not be accepted), if able to have children. - Have received less than 4 weeks treatment with any nucleoside reverse transcriptase inhibitor (NRTI) and have never received any nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI). Mothers who have previously received 1 dose of the NNRTI nevirapine during pregnancy for prevention of mother-to-child HIV transmission are permitted to enter the study. - Have a viral load (amount of HIV in the blood) of 1,000 copies/ml or more. Exclusion Criteria Patients will not be eligible for this study if they: - Abuse drugs or alcohol in a way that would interfere with study requirements. Patients who are stable on methadone will be considered for the study. - Have an active/acute CDC Category C event. - Are unable to absorb or take medicines by mouth. - Are pregnant or breast-feeding. - Have a serious medical condition (such as diabetes, heart problem, hepatitis) that might affect the safety of the patient. - Have had pancreatitis or hepatitis within the last 6 months. - Have been treated with radiation or chemotherapy within 28 days before the study drug will be taken, or will have the need for these during the study. - Have taken drugs that affect the immune system (such as corticosteroids, interleukins, interferons) or that have anti-HIV activity (such as hydroxyurea or foscarnet) within 28 days before the study drug will be taken. - Have received an HIV vaccine within 3 months before the study drug will be taken. - Have received certain other drugs within 28 days before the study drug will be taken, or think that they will be needed during the study. - Have received experimental treatments. - Have allergies which might interfere with the study, in the opinion of the doctor.
Total Enrollment: 624
Location and Contact Information:
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
United States
Southampton Healthcare Inc
St. Louis, Missouri, 63139
United States
Nicholas Bellos
Dallas, Texas, 75246
United States
Univ of Miami Dept of Medicine
Miami, Florida, 33136
United States
Therafirst Med Ctr
Ft. Lauderdale, Florida, 33308
United States
Orange County Ctr for Special Immunology
Fountain Valley, California, 92708
United States
Abbott-Northwestern Hosp / Clinic 42
Minneapolis, Minnesota, 55404
United States
SMO USA
Conyers, Georgia, 30013
United States
St Lukes - Roosevelt Hosp Ctr
New York City, New York, 10019
United States
Indiana Univ Med School
Indianapolis, Indiana, 46202
United States
VAMC New Jersey Healthcare System
East Orange, New Jersey, 07018
United States
LAGLC
Los Angeles, California, 90028
United States
North Shore Univ Hosp
Manhasset, New York, 11030
United States
Hahnemann Univ Hosp
Philadelphia, Pennsylvania, 19102
United States
Hawthorne Med Associates / PAACA
New Bedford, Massachusetts, 02745
United States
Bronx Veterans Affairs Med Ctr
Bronx, New York, 10468
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Park Ctr for Health / Keith Vrhel
San Diego, California, 92103
United States
Gary Richmond MD
Ft. Lauderdale, Florida, 33316
United States
Methodist Healthcare
Memphis, Tennessee, 38104
United States
Infectious Disease Research Inst
Tampa, Florida, 33614
United States
Joseph C Gathe
Houston, Texas, 77004
United States
AIDS Research Alliance
West Hollywood, California, 90069
United States
Infectious Diseases Associates
Sarasota, Florida, 34239
United States
CRI of South Florida
Coral Gables, Florida, 33146
United States
Kaiser Hospital
Sacramento, California, 95825
United States
Specialty Med Care Ctrs of South Florida Inc
Miami, Florida, 33142
United States
AIDS Healthcare Foundation
Los Angeles, California, 90027
United States
Jeffrey Levenson
St. Petersburg, Florida, 33710
United States
Infectious Disease Consultants
Altamonte Springs, Florida, 32701
United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 200091104
United States
Burnside Clinic
Columbia, South Carolina, 29206
United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
Univ of Cincinnati / Holmes Hosp
Cincinnati, Ohio, 452670405
United States
Med College of Georgia
Augusta, Georgia, 30912
United States
Brigham and Women's Hosp
Boston, Massachusetts, 02115
United States
Additional Information:
Study ID Numbers: 316B; APV30002
Study Start Date: November 2000
Record last reviewed: March 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00009061
Other Hiv Infections Studies:
1. A Study of Azithromycin in the Prevention of Mycobacterium avium Complex Disease (MAC) in HIV-Infected Patients
2. A Study to See If Taking One or Two Extra Drugs Can Lower HIV Levels in Patients Who Have Failed Their Anti-HIV Drug Treatment
3. Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants
4. A Comparison of Atazanavir and Nelfinavir, Each in Combination with 2 NRTIs, in Patients Who Have Failed Treatments without a Protease Inhibitor
5. A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS
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Comparison of GW433908/Ritonavir to Nelfinavir When Used with Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs
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