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Home > "A" Clinical Trials Conditions > A Study of 1592U89 in HIV-Infected Patients  A Study of 1592U89 in HIV-Infected Patients
A Study of 1592U89 in HIV-Infected Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: The purpose of this study is to see if it is safe to give 1592U89 to HIV-infected patients. This study also examines the effect 1592U89 has on plasma viral load (the level of HIV in the blood).
Details: Cohorts of 8 patients are entered sequentially into 1 of 6 1592U89 dosing regimens. All patients receive 12 weeks of monotherapy during the initial 12-week treatment phase. On completion of the treatment phase, patients are offered continuation therapy with 1592U89 for a minimum of 12 weeks.
Eligibility:
Study Type: Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: Prophylaxis for opportunistic infections. Patients must have: - HIV-1 infection. - CD4 cell count 100 - 500 cells/mm3 within 3 to 5 weeks prior to study drug administration. - No active diagnosis of AIDS (other than non-visceral Kaposi's sarcoma) according to the 1993 CDC AIDS surveillance definition. Exclusion Criteria Co-existing Condition: Patients with the following conditions and symptoms are excluded: - Malabsorption syndrome or other gastrointestinal dysfunction that may interfere with drug absorption. - Chronic disease such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that in the opinion of the investigator, would compromise the safety of the patient. Concurrent Medication: Excluded: - Immunomodulating agents. - Chemotherapeutic agents. - Antiretroviral therapy. NOTE: - Patients who elect to continue study treatment into the extended phase may, after consultation with their primary physician, combine 1592U89 at a recommended dose of 300 mg bid with other licensed antiretroviral drugs. Concurrent Treatment: Excluded: Radiation therapy. Patients with the following prior conditions are excluded: - History of clinically relevant hepatitis or pancreatitis within 6 months prior to study drug administration. - History of hypersensitivity, anaphylactic, or idiosyncratic reaction to nucleoside analogs. Prior Medication: Excluded: - Treatment with immunomodulating or cytotoxic chemotherapeutic agents within six weeks prior to study drug administration. - Antiretroviral therapy within 2 weeks prior to administration of study drugs. Prior Treatment: Excluded: Radiation therapy within six weeks prior to study drug administration. Current alcohol or illicit controlled substance use that in the opinion of the investigator, may interfere with the patient's ability to complete the study.
Total Enrollment: 48
Location and Contact Information:
Fenway Community Health Ctr / Research Dept
Boston, Massachusetts, 02115
United States
Albany Med College / Albany Med Ctr Hosp
Albany, New York, 12208
United States
Evanston Hosp / Clinical Pharmacology Unit
Evanston, Illinois, 60201
United States
Additional Information:
Study ID Numbers: 238G; CNAA1004
Study Start Date:
Record last reviewed: November 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002388
Other Hiv Infections Studies:
1. A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate With Leucovorin Protection for Patients With Pneumocystis carinii Pneumonia.
2. Niacin for Treatment of Elevated Cholesterol and Triglycerides in HIV-Infected Patients
3. Study of Total Body Irradiation in Combination With Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation Followed By Cyclosporine and Mycophenolate Mofetil in High Risk-Patients With Human Immunodeficiency Virus-1
4. A Phase I Trial of Tecogalan sodium ( DS-4152 ) Administered as an Infusion Weekly x 4
5. L-Carnitine to Treat Fatigue in AIDS Patients
Related Studies:
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A Study of 1592U89 in HIV-Infected Patients
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