Effect of Vicriviroc on HIV Ribonucleic Acid (RNA) Levels in Cerebrospinal Fluid (Study P05241)

NCT00632073 | Completed Phase 1

• 1 other identifier: P05241
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5 receptor blockers. This group of drugs blocks one of the ways HIV enters T-cells (the cells that fight infection). Previous studies in HIV treatment-experienced patients have shown that vicriviroc is safe and effective. The purpose of this study is to determine the effect of vicriviroc on HIV RNA levels in cerebrospinal fluid (CSF).

Conditions

HIV Infections

Keywords

HIV Infections; Acquired Immunodeficiency Syndrome; treatment experienced

Outcome Measures

Primary Outcomes (1)

• Change in HIV RNA levels in CSF

  Pretreatment and Week 2 visits

Secondary Outcomes (1)

• Proportion of subjects achieving CSF HIV RNA <50 copies/mL

  Week 2

Study Arms (1)

VCV + Failing HAART

EXPERIMENTAL

Vicriviroc plus failing highly-active antiretroviral therapy

Drug: Vicriviroc

Interventions

Vicriviroc DRUG

One tablet of vicriviroc maleate 30 mg once daily for 24 weeks (added to the subject's failing antiretroviral background regimen for 2 weeks, and then administered with optimized background therapy).

Also known as: Vicriviroc maleate, SCH-D, SCH 417690, VCV

VCV + Failing HAART

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A subject must be at least 18 years of age at the time of study entry, of either sex, and of any race.
• A subject must be infected with HIV-1 virus, as documented by a positive assay for HIV-1 RNA in plasma, prior to Screening.
• A subject's HIV isolate must be solely CCR5-tropic at Screening (ie, a subject must not have detectable CXCR4-tropic or dual/mixed CCR5/CXCR4-tropic HIV isolates).
• Subjects must be failing their current antiretroviral regimen with plasma HIV RNA \>=1000 copies/mL at the time of screening. (Note: The failing background regimen must contain a ritonavir-boosted PI, and may not include an NNRTI.)
• A subject must be willing to undergo study procedures including lumbar punctures, and to adhere to the chosen antiretroviral regimen.
• A subject must have a pretreatment CSF HIV RNA of \>=200 copies/mL.

You may not qualify if:

• A subject must not be taking medication for seizure control or have any condition that, in the judgment of the investigator, is likely to increase the risk of seizures.
• A subject must not have a prior history of malignancy (with the exception of surgically resected basal cell carcinoma with clear margins or Kaposi's sarcoma without visceral or mucosal involvement that resolved without systemic anticancer treatment).
• A subject must not have a contraindication to lumbar puncture (eg, bleeding diathesis or use of anticoagulants).

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

vicriviroc

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2008
• First Posted: March 10, 2008
• Study Start: March 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: March 1, 2010
• Last Updated: February 23, 2015

Record last verified: 2015-02