Clinical Trials

MainTitle

Vicriviroc (SCH 417690) Treatment Protocol in HIV-Infected Subjects: A Rollover Study for ACTG Protocol A5211 (Study P04100AM4)(COMPLETED)

This study has been completed
Sponsor
Merck Sharp & Dohme Corp.


Information provided by (Responsible Party)
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier
NCT00686829

First received: May 27, 2008
Last updated: February 20, 2015
Last Verified: February 2015
History of Changes
Purpose

Purpose

The purpose of this study is to provide open-label vicriviroc to HIV treatment-experienced subjects who successfully completed 48 weeks of treatment on ACTG protocol A5211 (or who responded favorably to treatment but discontinued participation due to viral tropism shifts), and subjects who screened for ACTG A5211 and met all inclusion and exclusion criteria, but were unable to enroll due to protocol closure. Vicriviroc will be administered in combination with an optimized background antiviral regimen, chosen by the investigator based on results of genotype and phenotype testing, the subject's history of prior antiretroviral drug use, and drug toxicity. OBT must include at least 3 antiviral drugs (not including vicriviroc), 1 of which is a ritonavir-boosted protease inhibitor.

Condition Intervention Phase
HIV Infections

Drug : Vicriviroc maleate
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vicriviroc (SCH 417690) Treatment Protocol in HIV-Infected Subjects: A Rollover Study for ACTG Protocol A5211 (Protocol No. P04100)

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures

  • Long-term safety and tolerability, including CD4/CD8 count, HIV RNA, vicriviroc drug-susceptibility testing, SAEs, new infections, AIDS-defining events, and changes in coreceptor tropism of HIV isolates. [ Time Frame: Throughout the study ]

Enrollment: 79
Study Start Date: June 2005
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Vicriviroc 30 mg QD
Vicriviroc 30 mg QD
Drug: Vicriviroc maleate

30 mg tablet for once daily oral administration until vicriviroc becomes commercially available.

Other Name: SCH 417690
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • Successful completion of ACTG Protocol A5211, or favorable response in A5211 but discontinued due to tropism shift, or screened for A5211 and met inclusion/exclusion criteria but unable to enroll due to protocol closure.
  • Subjects must also be on a ritonavir-containing antiretroviral regimen at entry, and have acceptable hematologic and laboratory parameters.
  • Female subjects of reproductive potential must agree to use 2 reliable methods of contraception, including a barrier method, and must have a negative urine pregnancy test prior to dosing.


Exclusion Criteria:
  • History of seizure or drug use that increases risk of seizure, current use of CYP3A4 inducers, prior history of malignancy, active drug or alcohol use or dependence that would interfere with study requirements
  • Females who are breast-feeding, pregnant, or plan to become pregnant
  • Participation in a clinical trial with another investigational drug.
  • Subjects with serious illness requiring systemic therapy and/or hospitalization must
not begin VCV (if not already on VCV) until subject completes therapy or is clinically stable on therapy for at least 14 days prior to enrollment.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686829

Sponsors and Collaborators

Merck Sharp & Dohme Corp.
More Information

More Information


Responsible Party: Merck Sharp & Dohme Corp.  
ClinicalTrials.gov Identifier: NCT00686829   History of Changes  
Other Study ID Numbers: P04100  
Study First Received: May 27, 2008  
Last Updated: February 20, 2015  

Keywords provided by Merck Sharp & Dohme Corp.:

HIV
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.