search
Back to results

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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
L-697,661
Zidovudine
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Evaluation, Drugs, Investigational, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • San Francisco Gen Hosp
  • Univ of Colorado Health Ctr / Denver Gen Hosp
  • Northwestern Univ Med School
  • Rush Presbyterian - Saint Luke's Med Ctr
  • Univ of Washington

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
July 29, 2008
Sponsor
Merck Sharp & Dohme LLC
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
search

1. Study Identification

Unique Protocol Identification Number
NCT00000628
Brief Title
A Pharmacokinetic Study of L-697,661 Alone and in Combination With Zidovudine
Official Title
A Pharmacokinetic Study of L-697,661 Alone and in Combination With Zidovudine
Study Type
Interventional

2. Study Status

Record Verification Date
October 1994
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Merck Sharp & Dohme LLC
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Evaluation, Drugs, Investigational, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Enrollment
27 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
L-697,661
Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RT Schooley
Official's Role
Study Chair
Facility Information:
Facility Name
San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States
Facility Name
Univ of Colorado Health Ctr / Denver Gen Hosp
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Northwestern Univ Med School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Univ of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
981224304
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Kuritzkes DR, Curtis S, Rosandich M, Stein DS, Schooley RT. Delayed emergence of resistance to L-697,661 in patients receiving concomitant zidovudine. The ACTG 184 Study Team. Int Conf AIDS. 1993 Jun 6-11;9(1):467 (abstract no PO-B26-1994)
Results Reference
background
PubMed Identifier
8673545
Citation
Schooley RT, Campbell TB, Kuritzkes DR, Blaschke T, Stein DS, Rosandich ME, Phair J, Pottage JC, Messari F, Collier A, Kahn J. Phase 1 study of combination therapy with L-697,661 and zidovudine. The ACTG 184 Protocol Team. J Acquir Immune Defic Syndr Hum Retrovirol. 1996 Aug 1;12(4):363-70. doi: 10.1097/00042560-199608010-00006.
Results Reference
background
Citation
Campbell TB, Routh JA, Bakhtiari M, Schooley RT, Kuritzkes DR. Detection of genotypic changes in reverse transcriptase during combination therapy with zidovudine and L-697,661. Detection of genotypic changes in reverse transcriptase during combination therapy with zidovudine and L-697,661. Int Conf AIDS. 1993 Jun 6-11;9(1):239 (abstract no PO-A26-0630)
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs