Enfuvirtide/Current Protease Inhibitor Switch to PREZISTA (Darunavir)/Ritonavir + TMC125 in HIV Patients With Enfuvirtide Side Effects.

NCT00460746 | Completed Phase 3 Results

• 2 other identifiers: CR011866TMC114HIV3009
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the safety, tolerability, and effectiveness of darunavir/ritonavir combined with TMC125 when current protease inhibitor(s), Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI(s)) and enfuvirtide are replaced by darunavir/ritonavir and TMC125 in HIV positive patients who can no longer tolerate enfuvirtide and are experiencing viral suppression. Other antiviral drugs in the regimen are to remain unchanged.

Conditions

HIV

Keywords

HIV; AIDS; Immunodeficiency Virus, Human; PREZISTA; darunavir; TMC114; TMC125; Protease Inhibitor; Non-Nucleoside Reverse Transcriptase Inhibitor; enfuvirtide; Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Who Maintain Plasma HIV Viral Load Measurements < 400 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.

  48 weeks

Secondary Outcomes (9)

• Proportion of Patients Who Have Viral Load Measurements <50 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.

  48 weeks

• CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline at 4, 8, 12, 16, 24, 36 and 48 Weeks.

  Week 48

• CD4+ Cell Count (x 10^6 Cell/L): Baseline and Mean Changes From Baseline at 4, 8, 12, 16, 24,36 and 48 Weeks.

  Week 48

• Median Change From Baseline in Triglycerides at Week 48.

  Week 48

• Median Change From Baseline in Total Cholesterol at Week 48.

  Week 48

Study Arms (1)

001

EXPERIMENTAL

TMC125, Darunavir; RitonavirTMC125-200mg two times a day for 48 weeks; Darunavir -200mg two times a day for 48 weeks; Ritonavir-100mg two times a day for 48 weeks;

Drug: TMC125, Darunavir; Ritonavir

Interventions

TMC125, Darunavir; Ritonavir DRUG

TMC125-200mg two times a day for 48 weeks; Darunavir -200mg two times a day for 48 weeks; Ritonavir-100mg two times a day for 48 weeks;

001

Eligibility Criteria

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

You may qualify if:

• Documented HIV-1 positive
• History of drug resistance or antiretroviral failure while receiving each of three drug classes: Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) and (protease inhibitors) PIs
• On a PI containing regimen with enfuvirtide with HIV viral load (VL) \< 400 copies/mL for 6 months or longer
• Continuously using the same PI regimen for 4 months prior to Screening
• Decline to continue enfuvirtide or their physician recommends discontinuation due to injection site reactions that persist despite optimal technique and training with available methods of administration or loss of sites for injection due to tissue nodules and hardening.

You may not qualify if:

• No use of any drug contraindicated in the current US package insert for PREZISTA (darunavir) or in the investigators brochure for TMC125
• No prior or current therapy with PREZISTA (darunavir) or TMC125
• No prior genotypic results demonstrating 3 or more darunavir resistance-associated mutations associated with diminished response to darunavir (V11I, V32I, L33F, I47V, I50V, I54L, I54M, G73S, L76V, I84V or L89V). Patients with \> 3 darunavir resistance-associated mutations with available darunavir phenotypes, may be enrolled if the resistance phenotype demonstrates: Fold Change (FC) \<10 to darunavir by PhenoSense GT (Monogram Biosciences) or FC \<10 to darunavir by Antivirogram (Virco, BVBA) or FC \<3.4 to darunavir by vircoTYPE (Virco BVBA)
• AST or ALT \>5 times ULN
• Calculated CrCl \< 30 ml/min.

Sponsors & Collaborators

• Tibotec, Inc: lead
• Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA: collaborator

Study Sites (1)

Unknown Facility

Los Angeles, California, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

etravirine; Darunavir; Ritonavir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles

Limitations and Caveats

Conclusions on efficacy and safety are limited as the target enrollment of 40 subjects was not reached due to a shortage of eligible subjects.

Results Point of Contact

• Title: Vice President, Tibotec Therapeutics Clinical Affairs
• Organization: Tibotec Therapeutics Clinical Affairs, Division of Centocor Ortho Biotech Services, LLC

rfalcon@its.jnj.com

877-732-2488

Study Officials

• Tibotec, Inc. Clinical Trial

  Tibotec, Inc

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2007
• First Posted: April 16, 2007
• Study Start: May 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: July 31, 2013
• Results First Posted: November 10, 2009

Record last verified: 2013-07

Locations

US (1)