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

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00686829

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 II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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:

MedlinePlus related topics: AIDS

Drug Information available for: Vicriviroc Vicriviroc maleate

U.S. FDA Resources

Further study details as provided by Schering-Plough:

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
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Vicriviroc 30 mg QD: Experimental Vicriviroc 30 mg QD	Drug: Vicriviroc maleate 30 mg tablet for once daily oral administration until vicriviroc becomes commercially available.

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

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04100
Study First Received:	May 27, 2008
Last Updated:	January 8, 2010
ClinicalTrials.gov Identifier:	NCT00686829 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Schering-Plough:

HIV
Treatment Experienced

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on February 08, 2010