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Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy Clinical research trials and Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy. Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy clinical trial. Subjects typically recieve the finest healthcare available for their Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy
Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Glaxo Wellcome ,
Synopsis: The purpose of this study is to compare GW433908 and nelfinavir when each is given with abacavir and lamivudine to HIV patients who have not taken antiretroviral drugs.
Details: Patients are randomized in a 2:1 scheme to 1 of 2 treatment groups. Group 1 receives GW433908 plus abacavir (ABC) plus lamivudine (3TC); Group 2 receives nelfinavir (NFV) plus ABC plus 3TC. Patients undergo safety and efficacy assessments at the Screening Visit, Day 1 (Entry), and Weeks 1, 2, 4, 8, 12, 16, 20, 24, and every 8 weeks thereafter. A follow-up visit is performed 4 weeks after the permanent discontinuation of study drug. Detailed assessments for the development of lipodystrophy/fat redistribution occur at Day 1, Week 24, Week 48, and every 16 weeks thereafter. Patients have examinations and laboratory tests performed at visits.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, 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 required 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 (NNRT) or protease inhibitor (PI). - Have a viral load (amount of HIV in the blood) of 5,000 copies/ml or more, or have a positive result at the screening visit. Exclusion Criteria Patients will not be eligible for this study if they: - Abuse drugs or alcohol in a way that would interfere with the study, in the opinion of the doctor. Patients stable on methadone will be considered for participation. - 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 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: 210
Location and Contact Information:
Clinical Pharmacology Services
Tampa, Florida, 33617
United States
Southwest Texas Methodist Hosp
San Antonio, Texas, 78229
United States
Saint Michael's Med Ctr
Newark, New Jersey, 07102
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
MacGregor Med Association
Houston, Texas, 77054
United States
Ocean View Internal Medicine
Long Beach, California, 90803
United States
Univ of Rochester Med Ctr
Rochester, New York, 14642
United States
Gervais Frechette
New York City, New York, 10011
United States
Howard Grossman
New York City, New York, 10011
United States
Hillsborough County Health Dept
Tampa, Florida, 33602
United States
Advanced Clinical Trials Inc
Eugene, Oregon, 97401
United States
Veterans Affairs Med Ctr of North Chicago
Chicago, Illinois, 60064
United States
Thomas Jefferson Univ
Philadelphia, Pennsylvania, 19107
United States
East Bay Clinical Trial Ctr
Concord, California, 94520
United States
Univ of Texas Med Branch
Galveston, Texas, 775550835
United States
Mount Sinai School of Medicine
New York City, New York, 10029
United States
Addiction Research and Treatment Corp
Brooklyn, New York, 11201
United States
SMO-USA Inc
Charlotte, North Carolina, 28211
United States
Univ of Kansas Med Ctr
Kansas City, Kansas, 661607415
United States
Brookdale Univ Hosp and Med Ctr
Brooklyn, New York, 112123198
United States
UMDNJ - New Jersey Med School
Newark, New Jersey, 071032757
United States
Walter Gaman
Irving, Texas, 75038
United States
Florida ID Group
Orlando, Florida, 32801
United States
Additional Information:
Study ID Numbers: 316A; APV30001
Study Start Date: November 2000
Record last reviewed: July 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008554
Other Hiv Infections Studies:
1. Diagnosing Tuberculosis in HIV Infected Children in Peru
2. A Study of Pyrimethamine in the Treatment of Infection by a Certain Parasite in HIV-Positive Patients
3. The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients with Hepatitis C Plus Advanced HIV Infections
4. Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children
5. Heterosexual HIV Transmission Study (HATS). Prospective Cohort Study
Related Studies:
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Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy
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