NCT00000628

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

July 30, 2008

Status Verified

October 1, 1994

First QC Date

November 2, 1999

Last Update Submit

July 29, 2008

Conditions

HIV Infections

Keywords

Drug EvaluationDrugs, InvestigationalDrug Therapy, CombinationAcquired Immunodeficiency SyndromeAIDS-Related ComplexAntiviral Agents

Interventions

L-697,661DRUG
ZidovudineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

San Francisco Gen Hosp

San Francisco, California, 941102859, United States

Location

Univ of Colorado Health Ctr / Denver Gen Hosp

Denver, Colorado, 80262, United States

Location

Northwestern Univ Med School

Chicago, Illinois, 60611, United States

Location

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, 60612, United States

Location

Univ of Washington

Seattle, Washington, 981224304, United States

Location

Related Publications (3)

  • 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)

    BACKGROUND

  • 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.

    PMID: 8673545BACKGROUND

  • 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)

    BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • RT Schooley

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

July 30, 2008

Record last verified: 1994-10

Locations

US(5)