Status:
COMPLETED
A Pharmacokinetic Study of L-697,661 Alone and in Combination With Zidovudine
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 th...
Detailed Description
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...
Eligibility 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00000628
Last Update
July 30 2008
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
2
Univ of Colorado Health Ctr / Denver Gen Hosp
Denver, Colorado, United States, 80262
3
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
4
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612