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Home > "A" Clinical Trials Conditions > A HIV Study Of A Fixed-Dose Combination Tablet In Antiretroviral Experienced Patients  A HIV Study Of A Fixed-Dose Combination Tablet In Antiretroviral Experienced Patients
A HIV Study Of A Fixed-Dose Combination Tablet In Antiretroviral Experienced Patients
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Sponsor Name Pending ,
Synopsis: This study is a 48-week study designed to evaluate the safety and efficacy of a fixed-dose combination tablet administered once-a-day versus the individual tablets administered twice-a-day within 3-drug combination regimens in ART (antiretroviral) -experienced HIV-1 infected patients.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: (Subjects must meet all of the following criteria in order to be eligible for this study.) - Currently receiving an initial antiretroviral therapy (ART) regimen composed of the drug abacavir (ABC) 300mg twice a day, plus the drug 3TC (lamivudine) 150mg twice a day in combination with either a protease inhibitor or non-nucleoside reductase inhibitor (NNRTI) for at least 24 weeks. - NOTE: Subjects who have required a change in initial protease inhibitor (PI) or NNRTI therapy due to intolerance (not treatment failure) are eligible. Subject must be on a stable regimen of the second PI or NNRTI therapy for at least 6 months before enrollment in this study. - Plasma HIV-1 RNA less than 400 copies/mL for at least 3 months immediately preceding the screening visit, and at screening. - CD4+ cell count of at least 50 cells/mm3 at screening. - Written informed consent to participate in the study before participation. - Male or female (Females of child-bearing potential must have a negative serum pregnancy test at screening and agree to an acceptable method of contraception.) Exclusion Criteria: (A subject will not be eligible for inclusion in this study if any of the following criteria apply.) - History of a CDC Clinical Category C event requiring treatment (not including cutaneous Kaposi's sarcoma) within 45 days of the screening visit. Treatment for the acute event must have been completed at least 30 days before screening. - Subject is enrolled in one or more investigational drug studies which may impact HIV RNA suppression. - Subject is unable to complete the 48-week dosing period, evaluations and assessments. - Subject is pregnant or breastfeeding. - History of clinically relevant inflammation of the pancreas or hepatitis within 6 months prior to screening. - Subject suffers from a serious medical condition, such as diabetes or heart problem. - Pre-existing mental, physical, or substance abuse disorder. - History of inflammatory bowel disease or malignancy, intestinal ischemia, malabsorption, or other gastrointestinal dysfunction. - Abnormal laboratory results within 28 days before the first dose of study medication. - Required treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days before screening, or will need these during the study. - Subject requires treatment with immunomodulating drugs such as systemic corticosteroids, interleukins, vaccines, or interferons within 28 days prior to screening, or subject has received an HIV-1 immunotherapeutic vaccine within 90 days prior to screening. - Asthmatic subjects using inhaled corticosteroids are eligible for enrollment. - Subject requires treatment with foscarnet, hydroxyurea or other agents with documented activity against HIV-1 in vitro within 28 days of screening. - Subject has a history of allergy to any of the study drugs.
Total Enrollment:
Location and Contact Information:
Study site
Los Angeles, California, 90033
United States
Study site
Newport Beach, California, 92663
United States
Study site
Dallas, Texas, 75219
United States
Study site
Phoenix, Arizona, 85006
United States
Study site
Dallas, Texas, 75246-1527
United States
Study site
San Jose, ,
Costa Rica
Study site
Sacramento, California, 95825
United States
Study site
Houston, Texas, 77027
United States
Study site
New York City, New York, 10019
United States
Study site
Columbia, South Carolina, 29206-4713
United States
Study site
Houston, Texas, 77004
United States
Study site
Dallas, Texas, 75219
United States
Study site
Tampa, Florida, 33614
United States
Study site
Somers Point, New Jersey, 08244
United States
Study site
Altamonte Springs, Florida, 32701
United States
Study site
Jacksonville, Florida, 32206
United States
Study site
Hershey, Pennsylvania, 17033
United States
Study site
Washington D.C., District of Columbia, 20009
United States
Study site
Long Beach, California, 90813
United States
Study site
Charlotte, North Carolina, 28203
United States
Study site
Augusta, Georgia, 30906
United States
Study Site
West Reading, Pennsylvania, 19611
United States
Study site
Dallas, Texas, 75208
United States
Study site
Denver, Colorado, 80220
United States
Study site
Baltimore, Maryland, 21201
United States
Study site
Miami, Florida, 33136
United States
Study site
Los Angeles, California, 90028
United States
Study site
Akron, Ohio, 44304
United States
Study site
Washington D.C., District of Columbia, 20009
United States
Study site
Knoxville, Tennessee, 37916
United States
Study site
Tampa, Florida, 33602
United States
Study site
Ft. Lauderdale, Florida, 33311
United States
Study site
Denver, Colorado, 80205
United States
Study site
Wichita, Kansas, 67214
United States
Study site
New York City, New York, 10011
United States
Study site
Greenville, North Carolina, 27858-4354
United States
Study site
Ft. Myers, Florida, 33901
United States
Study site
Washington D.C., District of Columbia, 20007
United States
Study site
Ft. Lauderdale, Florida, 33308
United States
Study site
Ponce, , 00731
Puerto Rico
Study site
Atlanta, Georgia, 30308
United States
Study site
Hillsborough, New Jersey, 08844
United States
Study site
Republica de Panama, ,
Panama
Study site
Tulsa, Oklahoma, 74114-3300
United States
Study site
Ft. Lauderdale, Florida, 33306
United States
Study site
Atlanta, Georgia, 30339
United States
Study site
Hampton, Virginia, 23666
United States
Study site
San Francisco, California, 94115
United States
Study site
Miami, Florida, 33136
United States
Study site
Stony Brook, New York, 11794-8153
United States
Study site
San Truce, , 00908
Puerto Rico
Study site
Durham, North Carolina, 27710
United States
Study site
Washington D.C., District of Columbia, 20037
United States
Study site
Miami, Florida, 33133
United States
Study site
Torrance, California, 90509
United States
Study site
Plantation, Florida, 33317
United States
Study site
St. Louis, Missouri, 63108
United States
Study site
Decatur, Georgia, 30033
United States
Study site
Ft. Lauderdale, Florida, 33316
United States
Study site
Bradenton, Florida, 34205
United States
Study site
Hershey, Pennsylvania, 17033
United States
Study site
Orlando, Florida, 32806
United States
Study site
New York City, New York, 10011
United States
Additional Information:
Study ID Numbers: ESS30008;
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00046176
Other Hiv Infections Studies:
1. A Study of Two Anti-HIV Drug Combinations in HIV-Infected Patients
2. A Study to Evaluate the Safety and Effectiveness of WF10 Given to Patients with Late-Stage HIV Disease
3. A Study to Compare Three Doses of T-20 When Given in Combination with Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults
4. The Effects of r-metHuIFN-gamma on the Lungs of Patients with AIDS
5. A Study to Prepare for Future HIV Vaccine Studies
Related Studies:
Other HIV Infections Clinical Trials
Other Arizona Clinical Trials
Other Phoenix Clinical Trials
A HIV Study Of A Fixed-Dose Combination Tablet In Antiretroviral Experienced Patients
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