A Pharmacokinetic Study of L-697,661 Alone and in Combination With Zidovudine

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000628
First received: November 2, 1999
Last updated: July 29, 2008
Last verified: October 1994

November 2, 1999
July 29, 2008
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Complete list of historical versions of study NCT00000628 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
HIV Infections
  • Drug: L-697,661
  • Drug: Zidovudine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000628
ACTG 184, Merck Protocol 020-00
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Merck Sharp & Dohme Corp.
National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: RT Schooley
National Institute of Allergy and Infectious Diseases (NIAID)
October 1994

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP