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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00460746
• Date of registration: 13/04/2007
• Primary sponsor: Tibotec, Inc
• Public title: Enfuvirtide/Current Protease Inhibitor Switch to PREZISTA (Darunavir)/Ritonavir + TMC125 in HIV Patients With Enfuvirtide Side Effects.
• Scientific title: Open Label Phase 3b, 48 wk Pilot Study of the Antiviral Efficacy and Tolerability of Combination of PREZISTA/r and TMC125 When Substituted for Enfuvirtide, Current Protease Inhibitor(s) and NNRTI(s) in Antiretroviral Resistant Patients With Viral Suppression But Who Are Intolerant of Enfuvirtide.
• Date of first enrolment: April 2007
• Target sample size: 10
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00460746
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Tibotec, Inc. Clinical Trial
• Affiliation: Tibotec, Inc

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV

Intervention(s)

Drug: TMC125, Darunavir; Ritonavir

Primary Outcome(s)

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. [Time Frame: 48 weeks]

Secondary Outcome(s)

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

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

Median Change From Baseline in Glucose at Week 48. [Time Frame: Week 48]

Median Change From Baseline in HDL Cholesterol. [Time Frame: Week 48]

Median Change From Baseline in LDL Cholesterol at Week 48. [Time Frame: Week 48]

Median Change From Baseline in Total Cholesterol (TC) / High Denisty Lipoprotein (HDL) Ratio at Week 48. [Time Frame: Week 48]

Median Change From Baseline in Total Cholesterol at Week 48. [Time Frame: Week 48]

Median Change From Baseline in Triglycerides at Week 48. [Time Frame: Week 48]

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. [Time Frame: 48 weeks]

Secondary ID(s)

CR011866

TMC114HIV3009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA