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Home > "A" Clinical Trials Conditions > A Pharmacokinetic Study of L-697,661 Alone and in Combination with Zidovudine  A Pharmacokinetic Study of L-697,661 Alone and in Combination with Zidovudine
A Pharmacokinetic Study of L-697,661 Alone and in Combination with Zidovudine
For Condition: HIV Infections
Status: Completed
Sponsor(s): Merck Research Laboratories , National Institute of Allergy and Infectious Diseases (NIAID)
Synopsis: Part 1: To study the potential safety and pharmacokinetic (blood level) effects of zidovudine (AZT) on L-697,661; to obtain additional pharmacokinetic information in humans with L-697,661; to study the effect of L-697,661 on hepatic enzyme induction. Part 2: To begin a study of the antiviral activity of L-697,661. L-697,661 is a newly identified compound that inhibits HIV replication (reproduction and growth) in cell culture. It works together with AZT against HIV.
Details: L-697,661 is a newly identified compound that inhibits HIV replication (reproduction and growth) in cell culture. It works together with AZT against HIV. Part 1: Twelve patients are randomly assigned to one of two groups. Group 1 patients receive AZT for 7 days, followed by AZT plus L-697,661 with food for 56 days. Group 2 patients receive no drug for 7 days, followed by L-697,661 with food for 56 days. Antipyrine is administered 1 hour prior to study drug on days 8, 22, and 35. Part 2: Fifteen patients receive L-697,661 with food, for 8 weeks. Therapy with L-697,661 may be extended beyond 8 weeks for up to 24 weeks.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HIV infection. Prior Medication: Included: - Patients in Part 1 must have received no previous zidovudine (AZT) or a stable dose of at least 500 mg/day without evidence of toxicity. - Patients in Part 2 must have received no previous AZT or = or > 300 mg/day for < 6 consecutive weeks within 1 year prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Acute HIV-related opportunistic infection requiring ongoing treatment. - Diarrhea defined as 3 or more liquid stools/day for one week. - Wilson's or Gilbert's disease, porphyria, or other chronic or acute hepatic disease. - Potentially life-threatening allergic reactions to any of the components of zidovudine. - Acute or chronic medical conditions that in the opinion of the investigator would place patient at risk by participation in this study. Concurrent Medication: Excluded: - Systemic bronchodilators, acetaminophen, aspirin. Prior Medication: Excluded: - Didanosine (ddI) or dideoxycytidine (ddC) within 14 days prior to entry. - Immune modulators or investigational drugs within 30 days prior to entry. - Drugs known to induce hepatocellular enzymes, such as phenobarbital, phenytoin, warfarin, ketoconazole, and oral contraceptives, within 30 days prior to entry. Patients in Part 2 only: Excluded: - Zidovudine within 4 weeks prior to receiving first dose of study drug. Risk Behavior: Excluded: - Patients who the investigator feels would not comply with study requirements. Patients may not have the following prior conditions: - Acute or chronic medical conditions that in the opinion of the investigator would place patient at risk by participation in this study. - Potentially life-threatening allergic reactions to any of the components of zidovudine.
Total Enrollment: 27
Location and Contact Information:
Overall Study Official:
RTSchooley, Study Chair,
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Univ of Colorado Health Ctr / Denver Gen Hosp
Denver, Colorado, 80262
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Additional Information:
Study ID Numbers: ACTG 184; Merck Protocol 020-00
Study Start Date:
Record last reviewed: October 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000628
Other Hiv Infections Studies:
1. A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)
2. The Effect of Valacyclovir on the Detection of HIV from Genital Herpes Lesions in HIV-Infected Patients
3. Treatment of Depression with Massage in HIV
4. Treatment of Hepatitis in Patients who are Triple-Infected with HIV, Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV)
5. A Randomized, Comparative Study of Daily Dapsone and Daily Atovaquone for Prophylaxis Against PCP in HIV-Infected Patients Who Are Intolerant of Trimethoprim and/or Sulfonamides
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A Pharmacokinetic Study of L-697,661 Alone and in Combination with Zidovudine
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