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| Sponsored by: |
Glaxo Wellcome |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002389 |
Purpose
To compare the durability of the viral load response following 48 weeks of treatment with 1592U89/lamivudine (3TC)/zidovudine (ZDV) versus 3TC/ZDV alone. To compare the early antiviral activity following 16 weeks treatment with 1592U89/3TC/ZDV versus 3TC/ZDV alone as demonstrated by the proportion of subjects with viral load < 400 copies/ml, plasma HIV-1 RNA profiles and CD4+ profiles. To assess the safety and tolerance following 16 and 48 weeks of treatment with 1592U89/3TC/ZDV versus 3TC/ZDV alone.
| Condition | Intervention | Phase |
|
HIV Infections |
Drug: Abacavir sulfate Drug: Lamivudine Drug: Zidovudine |
Phase III |
| MedlinePlus related topics: | AIDS AIDS Medicines |
| Drug Information available for: | Zidovudine Abacavir Abacavir sulfate Lamivudine |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Safety Study |
| Official Title: | A Randomized, Double-Blind, Parallel-Group, Multicenter Trial to Evaluate the Safety and Efficacy of 1592U89 in Combination With Lamivudine (3TC) and Zidovudine (ZDV) Versus 3TC/ZDV in HIV-1-Infected, Antiretroviral Therapy-Naive Subjects With CD4+ Counts >= 100 Cells/mm3 |
| Estimated Enrollment: | 210 |
This study compares the safety and efficacy of 1592U89 in combination with 3TC and ZDV versus control therapy with 3TC and ZDV alone. If a patient has two consecutive HIV-1 RNA measurements of >= 400 copies/ml (performed at least one week apart) he or she has the option to switch to open-label therapy with 1592U89/3TC/ZDV, to receive the remaining randomized treatment, or to discontinue study medication. If this criterion is not met, patients continue their randomly assigned therapy until the last patient has completed 48 weeks of therapy. Once patients enter the open-label phase, investigators may add or substitute non-nucleoside reverse transcriptase inhibitors, nucleoside reverse transcriptase inhibitors, or protease inhibitors for 3TC and/or ZDV according to their standard practice once patients enter the open-label phase.
Eligibility
| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions and symptoms are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Radiation therapy.
Patients with the following prior conditions are excluded:
History of clinically relevant pancreatitis or hepatitis within the last 6 months.
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Radiation therapy within 30 days of study period. Current alcohol or illicit drug use that, in the opinion of the investigator, may interfere with the patient's ability to comply with the dosing schedule and protocol evaluations.
Contacts and Locations| United States, California | |||||
| East Bay AIDS Ctr | |||||
| Berkeley, California, United States, 94705 | |||||
| Kraus Med Partners | |||||
| Los Angeles, California, United States, 90036 | |||||
| United States, District of Columbia | |||||
| Georgetown Univ Med Ctr | |||||
| Washington, District of Columbia, United States, 20007 | |||||
| United States, Florida | |||||
| Univ of Miami Dept of Medicine | |||||
| Miami, Florida, United States, 33136 | |||||
| United States, Illinois | |||||
| Rush Med College / Rush Presbyterian - St Luke's Med Cen | |||||
| Chicago, Illinois, United States, 60612 | |||||
| United States, Massachusetts | |||||
| Boston Med Ctr / Evans - 556 | |||||
| Boston, Massachusetts, United States, 021182393 | |||||
| United States, New Jersey | |||||
| Saint Michael's Med Ctr / Dept of Infectious Diseases | |||||
| Newark, New Jersey, United States, 07102 | |||||
| United States, New York | |||||
| Harlem Hosp | |||||
| New York, New York, United States, 10027 | |||||
| St Vincent's Hosp and Med Ctr / AIDS Ctr | |||||
| New York, New York, United States, 10011 | |||||
| United States, North Carolina | |||||
| Duke Univ Med Ctr / Dept of Medicine | |||||
| Durham, North Carolina, United States, 27710 | |||||
| United States, Ohio | |||||
| Univ of Cincinnati / Holmes Hosp | |||||
| Cincinnati, Ohio, United States, 452670405 | |||||
| United States, Texas | |||||
| Dr Nicholaos Bellos | |||||
| Dallas, Texas, United States, 75225 | |||||
| Baylor College of Medicine / Dept of Medicine | |||||
| Houston, Texas, United States, 770303498 | |||||
| Canada, Ontario | |||||
| Toronto Gen Hosp | |||||
| Toronto, Ontario, Canada | |||||
| Puerto Rico | |||||
| San Juan AIDS Program | |||||
| Santurce, Puerto Rico, 00907 | |||||
| Glaxo Wellcome |
More Information
| Study ID Numbers: | 238D |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002389 |
| Health Authority: | United States: Food and Drug Administration |
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