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A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination with Two Other Anti-HIV Drugs 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 A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination with Two Other Anti-HIV Drugs conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination with Two Other Anti-HIV Drugs Clinical research trials and A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination with Two Other Anti-HIV Drugs 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 A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination with Two Other Anti-HIV Drugs. A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination with Two Other Anti-HIV Drugs 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 A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination with Two Other Anti-HIV Drugs clinical trial. Subjects typically recieve the finest healthcare available for their A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination with Two Other Anti-HIV Drugs 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 > "A" Clinical Trials Conditions > A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination with Two Other Anti-HIV Drugs  A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination with Two Other Anti-HIV Drugs
A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination with Two Other Anti-HIV Drugs
For Condition: HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: The purpose of this study is to compare the safety and effectiveness of 2 dosing schedules (once daily vs twice daily) of lamivudine (3TC) given with stavudine (d4T) and either indinavir (IDV) or nelfinavir (NFV) for 24 weeks.
Details: Patients are randomized to 1 of 2 groups. Group 1 receives 3TC qd plus d4T plus either IDV or NFV. Group 2 receives 3TC bid plus d4T plus either IDV or NFV. Patients are evaluated for drug tolerance, medication adherence, and genotypic and phenotypic resistance.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-positive. - Are at least 18 years old. - Have had an HIV level below 400 copies/ml for at least 3 months prior to study entry. - Have a CD4 cell count of at least 50 cells/mm3. - Are currently taking an anti-HIV drug regimen that includes 3TC plus d4T plus either IDV or NFV for at least 6 months prior to study entry. (Note: This must be their first anti-HIV drug regimen.) - Agree to abstain from sex or use effective methods of birth control during the study. Exclusion Criteria Patients will not be eligible for this study if they: - Have a history of an AIDS-defining illness or certain other medical conditions. - Are allergic to any of the study drugs. - Are unable to take medication by mouth for any reason. - Have received certain medications. - Will need to receive radiation therapy or chemotherapy (for any cancer other than Kaposi's sarcoma) during the study. - Are pregnant or breast-feeding.
Total Enrollment:
Location and Contact Information:
IDC Research Initiative
Altamonte Springs, Florida, 32701
United States
Palo Alto Veterans Affairs Health Care System
Palo Alto, California, 94304
United States
MCP Hahnemann Univ Hosp
Philadelphia, Pennsylvania, 19102
United States
St Lukes - Roosevelt Hosp Ctr
New York City, New York, 10019
United States
Saint Vincents Hosp
New York City, New York, 10011
United States
AIDS Healthcare Foundation
Los Angeles, California, 90027
United States
Steinhart Medical Associates
Miami, Florida, 33133
United States
Southwest Infectious Disease Association / PA
Dallas, Texas, 75225
United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550
United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 200091104
United States
North Broward Hosp District
Ft. Lauderdale, Florida, 33316
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Additional Information:
Study ID Numbers: 225C; COLA 4005
Study Start Date: June 1999
Record last reviewed: August 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002442
Other Hiv Infections Studies:
1. A Study of Ritonavir (ABT-538) When Used with Nelfinavir in HIV-Infected Patients
2. Safety and Effectiveness of Four Anti-HIV Drug Combinations in HIV-Infected Children and Teens
3. A Study of the Safety and Effectiveness of an HIV Vaccine for HIV-Positive Patients Receiving Anti-HIV Drugs for at Least 2 Years
4. Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS
5. A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
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Other Philadelphia Clinical Trials
A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination with Two Other Anti-HIV Drugs
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