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A Study of 1592U89 in HIV-Infected Adults



A Study of 1592U89 in HIV-Infected Adults

For Condition: HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: The purpose of this study is to see if it is safe and effective to give 1592U89 to HIV-positive adults. This study also examines the influence previous anti-HIV treatment has on the effectiveness of 1592U89.
Details: Patients receive open-label 1592U89 administered orally in combination with at least one other antiretroviral agent that the patient has not previously received.
Eligibility:
Study Type:  Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: Erythropoietin, G-CSF and GM-CSF. Patients must have: - CD4+ cell count < 100 cells/mm3. - HIV-1 RNA > 30,000 copies/ml. - Signed, informed consent from parent or legal guardian for patient under 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Renal failure requiring dialysis. - Hepatic failure evident by grade 3/4 hyperbilirubinemia and AST 5 times the upper limit of normal. - Documented hypersensitivity to 1592U89. - Serious medical conditions, such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction, that would compromise the safety of the patient. - Participation in or ability to participate in an enrolling study of 1592U89. Required: At least 2 nucleoside reverse transcriptase inhibitors (NRTI) and one protease inhibitor (or intolerance to one protease inhibitor and one NRTI due to trying at least 2 different regimens with at least one protease inhibitor). Alcohol or illicit drug use that may interfere with the patient's compliance.
Total Enrollment: 

Location and Contact Information:

Glaxo Wellcome Inc
Research Triangle Park,  North Carolina,  277093398
United States
 


Additional Information:
Study ID Numbers:  238M;  CNAA3008
Study Start Date: 
Record last reviewed: December 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002200

Other Hiv Infections Studies:
1. A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients

2. A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS

3. The Safety and Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Taken AZT

4. A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients

5. Comparing FTC and Lamivudine in HIV-Infected Patients on a Stable Anti-HIV Drug Combination

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