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A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients Clinical research trials and A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients. A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients clinical trial. Human subjects often get the best healthcare available for their A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients  A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients
A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: The purpose of this study is to look at the effects of different anti-HIV drug combinations on body fat changes in HIV-positive patients who have never received anti-HIV therapy before.
Details: Patients are randomized to receive stavudine plus lamivudine plus nelfinavir, Combivir (zidovudine plus lamivudine) plus nelfinavir, or Combivir plus abacavir. Patients are stratified into 2 groups based on their screening plasma HIV-1 RNA: (1) greater than 1,000 up to 100,000 copies/ml or (2) greater than 100,000 up to 200,000 copies/ml. Measurements and evaluations for assessment of body fat composition, virologic and immunologic outcomes, markers of alterations in carbohydrate and lipid metabolism, and safety are performed at Baseline, Weeks 4, 8, 16, 24, and every 12 weeks thereafter until Week 96 or withdrawal. In addition, health-related quality of life and health care resource utilization data are collected at specified treatment visits.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, 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 at least 18 years old. - Are HIV-positive. - Have a CD4 count greater than 50 cells/mm3. - Have a viral load greater than 1,000 copies/ml but less than 200,000 copies/ml. - Have never received anti-HIV medications before. (However, less than 1 week of therapy with lamivudine or a protease inhibitor and less than 4 weeks of therapy with other nucleoside reverse transcriptase inhibitors [NRTIs] is allowed. No therapy with nonnucleoside reverse transcriptase inhibitors [NNRTIs] is allowed.) - Cannot bear children or agree to use effective methods of birth control during the study. Hormonal methods of birth control (such as birth control pills) are not considered effective for this study. Exclusion Criteria Patients will not be eligible for this study if they: - Have an active AIDS-defining opportunistic infection or disease that, in the doctor's opinion, would make them unable to participate. - Are unable, in the opinion of the doctor, to follow the dosing schedule and follow-up visit schedule. - Have a substance abuse problem that would interfere with taking the medications correctly or attending the clinic visits. - Are enrolled in another study. - Cannot take medications by mouth or absorb drugs. - Have hepatitis. - Have a serious medical condition such as diabetes, congestive heart failure, or other heart disease. - Need chemotherapy or radiation therapy (except for local treatment of Kaposi's sarcoma). - Are taking certain medications. - Are pregnant or breast-feeding.
Total Enrollment: 230
Location and Contact Information:
Community Health Care
Ft. Lauderdale, Florida, 33306
United States
Daniel Seekins
Tampa, Florida, 33607
United States
Orange County Health Dept
Orlando, Florida, 32805
United States
Carolinas Med Ctr
Charlotte, North Carolina, 28232
United States
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, 64108
United States
Miriam Hosp
Providence, Rhode Island, 02906
United States
THE Clinic
Los Angeles, California, 90008
United States
Longbeach Memorial Med Ctr
Longbeach, California, 90806
United States
Ponce de Leon Ctr
Atlanta, Georgia, 30308
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Immunity Care and Research Inc
Plantation, Florida, 33324
United States
Comprehensive Care Center
Ft. Lauderdale, Florida, 33316
United States
Thomas Street Clinic
Houston, Texas, 77009
United States
San Francisco Gen Hosp
San Francisco, California, 94110
United States
Maxine Liggins
Los Angeles, California, 90042
United States
South Jersey Infectious Diseases Inc
Somers Point, New Jersey, 08244
United States
Univ of Miami School of Medicine
Miami, Florida, 33136
United States
Children's Diagnostic Treatment Ctr
Ft. Lauderdale, Florida, 33301
United States
MCP Hahnemann Univ Hosp
Philadelphia, Pennsylvania, 19102
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666
United States
IDC Research Initiative
Altamonte Springs, Florida, 32701
United States
Infectious Disease Research Institute
Tampa, Florida, 33614
United States
Cook County Hosp
Chicago, Illinois, 60614
United States
Univ of Texas Southwestern Med Ctr
Dallas, Texas, 75235
United States
Arizona Clinical Research Ctr Inc
Tucson, Arizona, 85712
United States
Philip Brachman
Atlanta, Georgia, 30309
United States
Good Samaritan Hosp
Los Angeles, California, 90004
United States
South Shore Hosp
Miami, Florida, 33139
United States
UCLA Care Ctr
Los Angeles, California, 90095
United States
Summa Health System
Akron, Ohio, 44304
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 352942050
United States
HIV Outpatient Clinics / LA State Univ Med Ctr
New Orleans, Louisiana, 70112
United States
AIDS Healthcare Foundation
Los Angeles, California, 900276069
United States
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, 946021018
United States
WNC Community Health Services
Asheville, North Carolina, 28806
United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 782847881
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
Additional Information:
Study ID Numbers: 264P; ESS40002
Study Start Date: September 1999
Record last reviewed: November 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005106
Other Hiv Infections Studies:
1. Ritonavir and Indinavir in Children Failing Other Anti-HIV Treatment
2. A Study of Decreased Mental Function Associated with HIV
3. The Effects of Valproic Acid on Zidovudine Glucuronidation and Pharmacokinetics in HIV-Infected Patients.
4. A Study of Ritonavir (ABT-538) When Used with Nelfinavir in HIV-Infected Patients
5. A Study of Nevirapine Used Alone or in Combination with AZT in HIV-1-Infected Children
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other Longbeach Clinical Trials
A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients
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