A Pharmacokinetic Study of L-697,661 Alone and in Combination With Zidovudine
Completed · Phase 1
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00000628
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 27
- Last updated by the study team
- 2008-07-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- San Francisco Gen Hosp — San Francisco, California, United States
- Univ of Colorado Health Ctr / Denver Gen Hosp — Denver, Colorado, United States
- Northwestern Univ Med School — Chicago, Illinois, United States
- Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
- Univ of Washington — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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