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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 References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about 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 website devoted 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 evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as 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 permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes 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 often receive the most expert healthcare possible 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. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed 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 Phase II Open-Label Exploratory Study of Saquinavir + Zidovudine + Lamivudine in HIV Infected Patients
2. A Study of ddI in Children with AIDS Who Have Not Had Success with Zidovudine
3. Intensive Pharmacokinetics of the Nelfinavir-Rifabutin Interaction in Patients with HIV-Related Tuberculosis Treated with a Rifabutin-Based Regimen
4. A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia Derived HIV-1 Recombinant Envelope Glycoprotein (gp160) of Human Immunodeficiency Virus: Evaluation of a 200-mcg Dose
5. The Safety and Effectiveness of Zidovudine Plus Adefovir in HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other Florida Clinical Trials
Other Altamonte Springs 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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