Vicriviroc (SCH 417690) in Combination Treatment With Optimized ART Regimen in Experienced Participants (VICTOR-E1) (MK-7690-020/P03672)

NCT00243230 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: P036722005-001057-21MK-7690-020
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief Summary

Vicriviroc (vye-kri-VYE-rock) is an investigational drug that belongs to a new class of drugs, called C-C chemokine receptor type 5 (CCR5) receptor blockers. This group of drugs blocks one of the ways human immunodeficiency virus (HIV) enters T-cells (the cells that fight infection). The purpose of this 48-week study is to evaluate 2 dose levels of vicriviroc in participants with HIV who have not responded adequately to standard HIV treatments. This study was designed to evaluate the safety and efficacy of doses of vicriviroc, when taken in combination with other HIV drugs, in terms of ability to decrease the level of HIV (viral load) in the blood. The primary objective of the study was to evaluate antiviral efficacy of two doses of Vicriviroc maleate compared to placebo in combination with a protease inhibitor (PI)-containing optimized antiretroviral therapy (ART) regimen in CCR5-tropic HIV infected individuals failing a standard ART regimen.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Log10 Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) at Week 48 of the Double-blind Period

  HIV RNA was measured by AMPLICOR HIV-1 MONITOR Standard assay. For participants who had HIV RNA below the lower quantification of the Standard assay (LOQ of 400 copies/mL), the AMPLICOR HIV-1.5 UltraSensitive assay was performed. If the HIV RNA measurement was below the lower quantification of the UltraSensitive assay (LOQ of 50 copies/mL), a value of 49 was imputed. If a continuing participant has a missing HIV RNA value at the time point of interest, the geometric mean of immediately preceding and following values was used. If the participants had no subsequent following value or discontinued study treatment before the time point of interest, then the change from baseline was set to zero. Analysis was performed with a variance (ANOVA) model that adjusted for the treatment and stratification factors (intended enfuvirtide (T20) use in current newly-optimized background regimen (OBT) (Y/N) and HIV RNA at Screening (\> or ≤100,000 copies/mL)).

  Baseline and Week 48 of the Double-blind Period

Secondary Outcomes (24)

• Participants With ≥1.0 log10 Change From Baseline HIV RNA at Week 48 of the Double-blind Period

  Baseline and 48 Weeks of the Double-blind Period

• Participants With HIV RNA <400 Copies/mL at Week 48 of the Double-blind Period

  Week 48 of the Double-blind Period

• Participants With a Time to Loss of Virologic Response (TLOVR) Based on 0.5 Log10 Reduction by 48 Weeks of the Double-blind Period

  Up to 48 weeks of the Double-blind Period

• Change From Baseline in Log10 HIV RNA at Week 12 of the Double-blind Period

  Baseline and Week 12 of the Double-blind Period

• Change From Baseline in Log10 HIV RNA at Week 24 of the Double-blind Period

  Baseline and Week 24 of the Double-blind Period

Study Arms (4)

Double-Blind - Vicriviroc 30 mg

EXPERIMENTAL

Vicriviroc 30 mg once daily (QD), orally (PO), plus an open-label optimized antiretroviral therapy (ART) regimen containing a ritonavir-boosted protease inhibitor (PI/r) for 48 weeks.

Drug: Vicriviroc 30 mg; Drug: Background ART Regimen

Double-Blind - Vicriviroc 20 mg

EXPERIMENTAL

Vicriviroc 20 mg QD, PO, plus an open-label optimized ART regimen containing a PI/r for 48 weeks.

Drug: Vicriviroc 20 mg; Drug: Placebo; Drug: Background ART Regimen

Double-Blind - Placebo

PLACEBO COMPARATOR

Placebo QD, PO, plus an open-label optimized ART regimen containing a PI/r for 48 weeks.

Drug: Placebo; Drug: Background ART Regimen

Open-label - Vicriviroc 30 mg

EXPERIMENTAL

Vicriviroc 30 mg once daily (QD), orally (PO), plus an open-label optimized ART regimen containing a ritonavir-boosted protease inhibitor (PI/r) for up to 45 months.

Drug: Vicriviroc 30 mg; Drug: Background ART Regimen

Interventions

Vicriviroc 30 mg DRUG

Three tablets of vicriviroc 10 mg once daily for 48 weeks (Double-blind Period) or for up to 45 months (Open Label Period).

Also known as: SCH 417690

Double-Blind - Vicriviroc 30 mg; Open-label - Vicriviroc 30 mg

Vicriviroc 20 mg DRUG

Two tablets of vicriviroc 10 mg once daily for 48 weeks.

Also known as: SCH 417690

Double-Blind - Vicriviroc 20 mg

Placebo DRUG

Three tablets of placebo once daily for 48 weeks.

Double-Blind - Placebo

Background ART Regimen DRUG

An open-label ritonavir-boosted optimized background ART regimen containing ≥3 drugs (including a protease inhibitor \[PI\]) selected for each individual study participant by the investigator. The optimized regimens most commonly include new nucleoside analogs (NRTIs) and a PI, usually "boosted" with concomitant ritonavir.

Double-Blind - Placebo; Double-Blind - Vicriviroc 20 mg; Double-Blind - Vicriviroc 30 mg; Open-label - Vicriviroc 30 mg

Eligibility Criteria

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

You may qualify if:

• Adult participants with documented HIV infection with no detectable C-X-C Motif Chemokine Receptor 4 (CXCR4)
• Prior therapy for ≥3 months with ≥3 classes of currently marketed (US FDA-approved) antiretroviral agents (nucleoside reverse transcriptase inhibitor, NRTIs, non-nucleoside reverse transcriptase inhibitor (NNRTIs), protease inhibitor (PIs), or fusion inhibitors) at any time prior to screening
• HIV ribonucleic acid (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

You may not qualify if:

• No history of previous malignancy (with the exceptions of cutaneous Kaposi's Sarcoma without visceral or mucosal involvement that resolved with highly active antiretroviral therapy (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 central nervous system (CNS) condition or drug use predisposing to seizure in the opinion of the investigator
• No active acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Suleiman J, Zingman BS, Diaz RS, Madruga JV, DeJesus E, Slim J, Mak C, Lee E, McCarthy MC, Dunkle LM, Walmsley S. Vicriviroc in combination therapy with an optimized regimen for treatment-experienced subjects: 48-week results of the VICTOR-E1 phase 2 trial. J Infect Dis. 2010 Feb 15;201(4):590-9. doi: 10.1086/650342.

  PMID: 20064072 DERIVED

MeSH Terms

Conditions

HIV Infections

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

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: There were Double-blind and an Open Label extension period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2005
• First Posted: October 21, 2005
• Study Start: September 19, 2005
• Primary Completion: October 19, 2007
• Study Completion: March 17, 2011
• Last Updated: June 8, 2021
• Results First Posted: June 8, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share