Completed

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

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What is being tested

L-697,661

+ Zidovudine

Drug
Who is being recruted

Blood-Borne Infections+14

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC
Last updated: July 30, 2008
Sourced from a government-validated database.Claim as a partner

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.

NCT00000628
Principal SponsorMerck Sharp & Dohme LLC
Last updated: July 30, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

27 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexHIV Infections

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

San Francisco Gen Hosp

San Francisco, United StatesOpen San Francisco Gen Hosp in Google Maps

Univ of Colorado Health Ctr / Denver Gen Hosp

Denver, United States

Northwestern Univ Med School

Chicago, United States

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, United States
Completed5 Study Centers