NCT00243568

Brief Summary

This is an international study of vicriviroc in 500 adult HIV-infected subjects who are failing standard antiretroviral therapy (ART). HIV must be of a certain type known as R5/X4-mixed tropic. Subjects allowed into the trial will be randomly assigned to treatment with vicriviroc 10 mg QD, vicriviroc 15 mg QD, or placebo in addition to other antiretrovirals (selected by the investigator to be optimal for the specific subject) containing at least 3 drugs, including a protease inhibitor (PI) boosted with at least 100 mg ritonavir QD. Subjects will be continued for up to 48 weeks of dosing.

Trial Health

10
At Risk

Trial Health Score

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

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2005

Completed
Last Updated

September 12, 2019

Status Verified

September 1, 2019

First QC Date

October 20, 2005

Last Update Submit

September 10, 2019

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Keywords

HIV InfectionsAcquired Immunodeficiency SyndromeCCR5/CXCR4 mixed tropismR5/X4 mixed tropismCCR5 inhibitorvicriviroctreatment-experienced

Interventions

VicrivirocDRUG

Eligibility Criteria

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

You may qualify if:

  • Adult subjects with documented R5/X4 mixed-tropic HIV infection
  • Prior therapy for greater than or equal to 3 months with greater than or equal to 3 classes of currently marketed antiretroviral agents (NRTIs, NNRTIs, PIs, or fusion inhibitors) at any time prior to screening
  • HIV RNA greater than or equal to 5000 copies/mL on a stable ART regimen of at least 3 months of duration
  • Greater than or equal to 1 genotypically documented resistance mutation to a reverse transcriptase (RT) inhibitor and greater than or equal to 1 primary resistance mutation to a PI
  • Acceptable hematologic, renal, and hepatic laboratory parameters.

You may not qualify if:

  • No history of recurrent seizure or CNS condition predisposing to seizure
  • No active AIDS-defining opportunistic infection
  • Subjects who have previously used a CCR5 inhibitor for greater than 4 weeks and/or within 30 days of the screening visit
  • Use of any drugs that predispose to seizures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

vicriviroc

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
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2005

First Posted

October 24, 2005

Study Start

September 1, 2005

Last Updated

September 12, 2019

Record last verified: 2019-09