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Home > "A" Clinical Trials Conditions > A Study to Compare Two Anti-HIV Drug Combinations A Study to Compare Two Anti-HIV Drug Combinations
A Study to Compare Two Anti-HIV Drug Combinations
For Condition: HIV Infections
Status: Completed
Sponsor(s): Hoffmann-La Roche ,
Synopsis: The purpose of this study is to compare 2 anti-HIV drug combinations.
Details: Patients are stratified by HIV RNA: 5,000-75,000 vs greater than 75,000 copies/ml by Amplicor assay. Patients are randomized to two arms. Arm A receives SQV plus RTV plus two NRTIs. Arm B receives EFV plus two NRTIs. Patients must take their dose at approximately the same time every day. Patients have the option of taking daily dose in AM or PM. Patients are evaluated for changes in plasma HIV RNA levels and CD4/CD8 counts and for adverse experiences and laboratory determinations. Evaluations are made every 4-8 weeks until Week 48. Patients continuing beyond Week 48 who reach Weeks 60, 72, 84, and common study closure, will be seen at those weeks.
Eligibility:
Study Type: Interventional, Treatment, Efficacy 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. - Have a viral load of at least 5,000 copies/ml and a CD4 cell count of at least 75 cells/mm3. - Are at least 18. - Are able to complete the study. Exclusion Criteria Patients will not be eligible for this study if they: - Have taken any anti-HIV medications for more than 2 weeks. - Are pregnant or breast-feeding.
Total Enrollment: 146
Location and Contact Information:
Overall Study Official:
JSGMontaner, Principal Investigator,
Ponce Univ Hosp
Ponce, , 00731
Puerto Rico
Saint Paul's Hosp
Vancouver, British Columbia,
Canada
Toronto Gen Hosp
Toronto, Ontario,
Canada
Univ of Alabama at Birmingham / AIDS Outpatient Clinic
Birmingham, Alabama, 35294
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
East Carolina Univ School of Medicine
Greenville, North Carolina, 27858
United States
Univ of Washington / AIDS Clinical Trial Unit
Seattle, Washington, 98104
United States
Greenville Hospital System
Greenville, South Carolina, 29605
United States
LIJMC
New Hyde Park, New York, 11040
United States
Associates in Research
Ft. Myers, Florida, 33901
United States
Illinois Masonic Med Ctr
Chicago, Illinois, 606575147
United States
Elmhurst Hosp
Elmhurst, New York, 11373
United States
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, 33136
United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
United States
Infectious Disease Specialists of NJ
Union, New Jersey, 07083
United States
Queens Hospital Center
Jamaica, New York, 11432
United States
Burnside Clinic
Columbia, South Carolina, 29206
United States
Joseph Gathe
Houston, Texas, 77004
United States
Lehigh Valley Hosp
Allentown, Pennsylvania, 18105
United States
Centre Hospitalier de la Universite de Montreal (CHUM)
Montreal, Quebec,
Canada
St Mary's Med Ctr
Long Beach, California, 90813
United States
Nicholas Bellos
Dallas, Texas, 75246
United States
Kaiser Foundation Hospital
San Francisco, California, 94118
United States
Physicans Home Service
Washington D.C., District of Columbia, 20037
United States
Univ of Utah
Salt Lake City, Utah, 84132
United States
Saint Michael's Med Ctr / Dept of Infectious Diseases
Newark, New Jersey, 07102
United States
Additional Information:
Study ID Numbers: 229R; NR15720C/M61027
Study Start Date: October 1999
Record last reviewed: January 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002447
Other Hiv Infections Studies:
1. Effectiveness of Treating HIV-Positive Patients with an HIV Vaccine (Remune)
2. A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients
3. Treatment of AIDS and AIDS Related Complex. Part-1- Treatment of Patients With ARC (AZT vs. Placebo)
4. A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3
5. Safety of Tenofovir Disoproxil Fumarate (TDF) in HIV Infected Pregnant Women and Their Infants
Related Studies:
Other HIV Infections Clinical Trials
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Other Miami Clinical Trials
A Study to Compare Two Anti-HIV Drug Combinations
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