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| Sponsored by: |
Glaxo Wellcome |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00004981 |
Purpose
The purpose of this study is to look at the safety and effectiveness of a pill called Trizivir that is a combination of three anti-HIV drugs (zidovudine, lamivudine, and abacavir). Zidovudine and lamivudine are often given combined in one pill (Combivir). In this study, Trizivir will be compared to Combivir plus abacavir.
| Condition | Intervention | Phase |
|
HIV Infections |
Drug: Abacavir sulfate, Lamivudine and Zidovudine Drug: Lamivudine/Zidovudine Drug: Abacavir sulfate |
Phase III |
| MedlinePlus related topics: | AIDS AIDS Medicines |
| Drug Information available for: | Zidovudine Abacavir Abacavir sulfate Lamivudine Combivir Trizivir |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | A Phase IIIB Randomized, Multicenter Study of the Efficacy and Safety of Combivir 1 Tablet Po Bid Plus Ziagen 300mg Po Bid Versus an Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg Combination Tablet Po Bid, Administered for 24 Weeks in Subjects With HIV-1 Infection |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
Contacts and Locations| United States, California | |||||
| St Lukes Medical Group | |||||
| San Diego, California, United States, 92101 | |||||
| Robert Scott MD | |||||
| Oakland, California, United States, 94609 | |||||
| AIDS Healthcare Foundation | |||||
| Los Angeles, California, United States, 900276069 | |||||
| Tower Infectious Disease Med Ctr | |||||
| Los Angeles, California, United States, 90048 | |||||
| United States, District of Columbia | |||||
| Georgetown Univ Med Ctr | |||||
| Washington, District of Columbia, United States, 20007 | |||||
| Whitman Walker Clinic | |||||
| Washington, District of Columbia, United States, 20009 | |||||
| United States, Florida | |||||
| Univ of Miami School of Medicine | |||||
| Miami, Florida, United States, 33136 | |||||
| Specialty Med Care Ctrs of South Florida Inc | |||||
| Miami, Florida, United States, 33142 | |||||
| Saint Josephs Comprehensive Research Institute | |||||
| Tampa, Florida, United States, 33607 | |||||
| United States, Georgia | |||||
| AIDS Research Consortium of Atlanta | |||||
| Atlanta, Georgia, United States, 30308 | |||||
| United States, Illinois | |||||
| Rush Presbyterian - Saint Luke's Med Ctr | |||||
| Chicago, Illinois, United States, 60612 | |||||
| United States, Massachusetts | |||||
| New England Med Ctr | |||||
| Boston, Massachusetts, United States, 02111 | |||||
| United States, Missouri | |||||
| Research Med Ctr | |||||
| Kansas City, Missouri, United States, 64111 | |||||
| United States, New York | |||||
| Saint Vincent's Hosp and Med Ctr | |||||
| New York, New York, United States, 10011 | |||||
| St Luke Roosevelt Hosp | |||||
| New York, New York, United States, 10011 | |||||
| Addiction Research and Treatment Corp | |||||
| Brooklyn, New York, United States, 11201 | |||||
| United States, Pennsylvania | |||||
| Anderson Clinical Research | |||||
| Pittsburgh, Pennsylvania, United States, 15213 | |||||
| Lehigh Valley Hosp | |||||
| Allentown, Pennsylvania, United States, 18105 | |||||
| Hahnemann Univ Hosp | |||||
| Philadelphia, Pennsylvania, United States, 191021192 | |||||
| United States, South Carolina | |||||
| Burnside Clinic | |||||
| Columbia, South Carolina, United States, 29206 | |||||
| United States, Tennessee | |||||
| Univ of Tennessee | |||||
| Memphis, Tennessee, United States, 38163 | |||||
| Nashville Health Management Foundation / Vanderbilt Univ | |||||
| Nashville, Tennessee, United States, 37203 | |||||
| United States, Texas | |||||
| Univ of Texas Med Branch | |||||
| Galveston, Texas, United States, 77555 | |||||
| Therapeutic Concepts | |||||
| Houston, Texas, United States, 77004 | |||||
| Nicholas Bellos | |||||
| Dallas, Texas, United States, 75246 | |||||
| Glaxo Wellcome |
More Information
| Study ID Numbers: | 308A, ESS40005 |
| First Received: | March 13, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004981 |
| Health Authority: | United States: Food and Drug Administration |
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