Trial record 12 of 30 for:    " April 30, 2008":" May 30, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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.

No Contacts or Locations Provided
  More Information

Publications:
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: March 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
HIV
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 19, 2014