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Study Of A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy



Study Of A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy

For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Sponsor Name Pending ,
Synopsis: This is a 48 week study to evaluate the safety and efficacy of a new tablet formulation containing two FDA-approved drugs in HIV-infected patients who have not received prior therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily regimen. Study physicians will evaluate subjects to determine if they have certain medical conditions, laboratory test values, medication use, or drug allergies that would exclude them from the study.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion criteria (subjects must meet the following criteria in order to be eligible for this study): - Participants must be able to provide informed consent. - At least 18 years of age. - Have documented HIV-1 infection. - Have not received more than 14 days of prior treatment with antiretroviral drugs. - Meet laboratory test criteria. - Women of childbearing potential must abstain from sexual intercourse or use acceptable contraception. - Must be able to take study medications as directed and complete all study visits and evaluations during the 48 week study. Exclusion criteria (subjects cannot meet the following criteria in order to be eligible for this study): - Enrolled in other HIV treatment studies. - Pregnant or breastfeeding.
Total Enrollment: 

Location and Contact Information:

Study Site
New Orleans,  Louisiana,  70127
United States
 

Study Site
Ft. Lauderdale,  Florida,  33306
United States
 

Study Site
Minneapolis,  Minnesota,  55404
United States
 

Study Site
Albany,  New York,  12208
United States
 

Study Site
Dallas,  Texas,  75028
United States
 

Study Site
New York City,  New York,  10011
United States
 

Study Site
Albuquerque,  New Mexico,  87131
United States
 

Study Site
Ft. Lauderdale,  Florida,  33308
United States
 

Study Site
Fountain Valley,  California,  92708
United States
 

Study Site
Tyler,  Texas,  75708
United States
 

Study Site
Denver,  Colorado,  80205
United States
 

Study Site
Denver,  Colorado,  80220
United States
 

Study Site
Newport Beach,  California,  92663
United States
 

Study Site
Tacoma,  Washington,  98405
United States
 

Study Site
Phoenix,  Arizona,  85006
United States
 

Study Site
San Francisco,  California,  94115
United States
 

Study Site
Tampa,  Florida,  33602
United States
 

Study Site
Atlanta,  Georgia,  30339
United States
 

Study Site
Houston,  Texas,  77030
United States
 

Study Site
Philadelphia,  Pennsylvania,  19102
United States
 

Study Site
Houston,  Texas,  77030
United States
 

Study Site
Beverly Hills,  California,  90211
United States
 

Study Site
Orlando,  Florida,  32806
United States
 

Study Site
Decatur,  Georgia,  30033
United States
 

Study Site
Vancouver,  Washington,  98664
United States
 

Study Site
Cincinnati,  Ohio,  45267
United States
 

Study Site
Washington D.C.,  District of Columbia,  20009
United States
 

Study Site
Stony Brook,  New York,  11794
United States
 

Study Site
Washington D.C.,  District of Columbia,  20037
United States
 

Study Site
Buffalo,  New York,  14215
United States
 

Study Site
Atlanta,  Georgia,  30309
United States
 

Study Site
Dallas,  Texas,  75246
United States
 

Study Site
St. Louis,  Missouri,  63108
United States
 

Study Site
Miami,  Florida,  33136
United States
 

Study Site
Indianapolis,  Indiana,  46202
United States
 

Study Site
Washington D.C.,  District of Columbia,  20037
United States
 

Study Site
Providence,  Rhode Island,  02906
United States
 

Study Site
Bradenton,  Florida,  34205
United States
 

Study Site
Ft. Myers,  Florida,  33901
United States
 

Study Site
Lynchburg,  Virginia,  24501
United States
 

Study Site
Ft. Worth,  Texas,  76104
United States
 

Study Site
Jacksonville,  Florida,  32206
United States
 

Study Site
Miami,  Florida,  33133
United States
 

Study Site
Fort Collins,  Colorado,  80528
United States
 

Study Site
Vero Beach,  Florida,  32960
United States
 

Study Site
New York City,  New York,  10014
United States
 

Study Site
West Reading,  Pennsylvania,  19611
United States
 

Study Site
Hampton,  Virginia,  23666
United States
 

Study Site
Chicago,  Illinois,  60657
United States
 

Study Site
Ft. Lauderdale,  Florida,  33316
United States
 

Study Site
Columbia,  South Carolina,  29206
United States
 

Study Site
Hillsborough,  New Jersey,  08844
United States
 

Study Site
Charlotte,  North Carolina,  28203
United States
 

Study Site
Altamonte Springs,  Florida,  32701
United States
 

Study Site
Washington D.C.,  District of Columbia,  20007
United States
 

Study Site
Philadelphia,  Pennsylvania,  19107
United States
 

Study Site
Milwaukee,  Wisconsin,  53226
United States
 

Study Site
Seattle,  Washington,  98122
United States
 

Study Site
Los Angeles,  California,  90033
United States
 

Study Site
Portland,  Oregon,  97219
United States
 

Study Site
Wichita,  Kansas,  67214
United States
 

Study Site
Randolph,  New Jersey,  07869
United States
 

Study Site
New Orleans,  Louisiana,  70115
United States
 


Additional Information:
Study ID Numbers:
  ESS30009; 
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053638

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