Study 14 of 38 for search of: Dominican Republic
Previous Study Return to Search Results Next Study

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Vicriviroc (SCH 417690) in Combination Treatment With Optimized ART Regimen in Experienced Subjects (VICTOR-E1) (Study P03672AM5)
This study is ongoing, but not recruiting participants.
Sponsored by: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00243230
  Purpose

This is a randomized, placebo-controlled, multi-site, parallel-group, double-blind study of vicriviroc maleate(SCH417690) in approximately 120 adult HIV-infected subjects with no detectable X4-tropic virus who have >=1000 copies/mL plasma HIV RNA despite receiving a standard antiretroviral therapy (ART) regimen for at least 6 weeks prior to Screening and at least 8 weeks prior to randomization. Subjects must have previously received >= 3 months of at least 3 classes of marketed antiretrovirals and their HIV must exhibit >=1 resistance mutation to NRTIs and >=1 primary resistance mutation to PIs. Eligible subjects will be randomized to treatment with vicriviroc maleate 20 mg QD, 30 mg QD or placebo and will, in addition, be prescribed an optimized background regimen of marketed antiretrovirals selected on the basis of the susceptibility pattern of their HIV as determined by genotype and phenotype testing, the subject's history of prior antiretroviral use, and drug toxicity. OBT must include at least 3 antiretroviral drugs (not including study drug), 1 of which must be a ritonavir-boosted protease inhibitor (>=100 mg ritonavir). The vicriviroc maleate or placebo doses will be blinded while the optimized background will be open-label. Study visits after Day 1 are scheduled for Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 32, 40 and 48. Safety will be monitored by standard laboratory tests, assessment of adverse events and emergence of complicating medical conditions, including AIDS-defining events. Cardiac safety will be monitored periodically by ECG and plasma samples will be collected from all subjects at several time points through the study for population pharmacokinetic analyses. After Week 48, subjects will be offered open-label vicriviroc 30 mg QD until commercially available or until the sponsor terminates the clinical development of vicriviroc. Additionally, subjects who discontinued early from the study prior to Week 48 will be offered re-screening for the open-label segment of the study. During the open-label segment of the study, safety will be monitored by standard laboratory tests, assessment of AEs and emergence of complicating medical conditions. Subjects who terminate participation in either the double-blinded portion or open-label segment of the study will be requested to consent to enter a registry in order to evaluate long-term clinical outcome for up to 5 years.


Condition Intervention Phase
HIV Infections
Drug: Vicriviroc maleate 20 mg
Drug: Vicriviroc maleate 30 mg
Drug: Placebo
Phase II

MedlinePlus related topics: AIDS
Drug Information available for: Vicriviroc Vicriviroc maleate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Vicriviroc (SCH 417690) in Combination Treatment With Optimized ART Regimen in Experienced Subjects (VICTOR-E1)

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Log10 change from baseline in HIV RNA [ Time Frame: 48 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects with >=1.0 log10 change from baseline in HIV RNA; Proportion of subjects with HIV RNA <400 copies/mL; Time to virologic failure [ Time Frame: 48 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2005
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Vicriviroc 20 mg: Experimental Drug: Vicriviroc maleate 20 mg
Two tablets of vicriviroc maleate 10 mg and one tablet of placebo once daily for 48 weeks, then one tablet of vicriviroc maleate 30 mg once daily until commercially available.
Vicriviroc 30 mg: Experimental Drug: Vicriviroc maleate 30 mg
Three tablets of vicriviroc maleate 10 mg once daily for 48 weeks, then one tablet of vicriviroc maleate 30 mg once daily until commercially available.
Placebo: Placebo Comparator Drug: Placebo
Three tablets of placebo once daily for 48 weeks, then one tablet of vicriviroc maleate 30 mg once daily until commercially available.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult subjects with documented HIV infection with no detectable CXCR4
  • Prior therapy for >=3 months with >=3 classes of currently marketed (US FDA-approved) antiretroviral agents (NRTIs, NNRTIs, PIs, or fusion inhibitors) at any time prior to screening
  • HIV RNA >=1000 copies/mL on a stable ART regimen for >= 6 weeks prior to Screening and >=8 weeks prior to randomization
  • >=1 genotypically documented resistance mutation to a reverse transcriptase (RT) inhibitor and >=1 primary resistance mutation to a PI
  • Acceptable hematologic, renal and hepatic laboratory parameters

Exclusion Criteria:

  • No history of previous malignancy (with the exceptions of cutaneous Kaposi's Sarcoma without visceral or mucosal involvement that resolved with HAART but without systemic anti-cancer treatment, and basal-cell carcinoma of skin surgically resected with disease-free margins on pathology exam)
  • Treatment with cytotoxic cancer chemotherapy,
  • Recurrent seizure, or CNS condition or drug use predisposing to seizure in the opinion of the investigator
  • No active AIDS-defining opportunistic infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00243230

  Show 78 Study Locations
Sponsors and Collaborators
Schering-Plough
  More Information

Responsible Party: Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers: P03672, EudraCT number 2005-001057-21
Study First Received: October 20, 2005
Last Updated: January 9, 2009
ClinicalTrials.gov Identifier: NCT00243230  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009