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:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00686829
First received: May 27, 2008
Last updated: March 19, 2014
Last verified: March 2014

May 27, 2008
March 19, 2014
June 2005
October 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00686829 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Vicriviroc (SCH 417690) Treatment Protocol in HIV-Infected Subjects: A Rollover Study for ACTG Protocol A5211 (Study P04100AM4)(COMPLETED)
Vicriviroc (SCH 417690) Treatment Protocol in HIV-Infected Subjects: A Rollover Study for ACTG Protocol A5211 (Protocol No. P04100)

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Vicriviroc maleate
30 mg tablet for once daily oral administration until vicriviroc becomes commercially available.
Other Name: SCH 417690
Experimental: Vicriviroc 30 mg QD
Vicriviroc 30 mg QD
Intervention: Drug: Vicriviroc maleate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
79
October 2010
October 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00686829
P04100
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP