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)

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Page 1 of 2 (5 locations)

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