A Study to Evaluate the Pharmacokinetic Profile (How the Body Absorbs, Distributes, Metabolizes and Eliminates a Drug) of TMC125 Plus Tenofovir/Emtricitabine Once Daily With or Without Darunavir/r Once Daily in Antiretroviral (ARV) Naive HIV-1 Patients (Patients Have Never Received ARV Treatment).

NCT00534352 | Completed Phase 2 Results

• 2 other identifiers: CR014485TMC125HIV2032
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the pharmacokinetic profile of TMC125 400mg with tenofovir DF/emtricitabine FDC (fixed dose combination) 300/200mg all dosed once daily with and without darunavir/ritonavir 800/100 mg once daily in HIV-1 infected, antiretroviral (ARV) naÃ-ve patients (patients who have never received ARV treatment).

Conditions

HIV-1 Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants Contributing to the Pharmacokinetic (PK) Evaluations: Cmin, Cmax, AUC24 & Css,av

  At visit Days 14 \& 28, samples were collected pre-dose and at 1, 2, 3, 4, 6, 9, and 12 hours post-dose. An additional sample was taken at 24 hours (Day 15 or 29 as applicable) post-dose.

  6 weeks

Secondary Outcomes (11)

• Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose-Hyperglycemia

  Day 1 through 42 and Week 48

• Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose- Hypoglycemia

  Day 1 through 42 and Week 48

• Number of Participants With Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Glucose- Insulin

  Day 1 through 42 and Week 48

• Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Lipids- Total Cholesteral

  Day 1 through 42 and Week 48

• Number of Participants With Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Lipids- High-density Lipoprotein (HDL)

  Day 1 through 42 and Week 48

Study Arms (1)

001

EXPERIMENTAL

TMC125; darunavir; ritonavirTMC125 400mg once daily for 4 weeks; Darunavir-800mg once daily for 48 weeks; Ritonavir-100mg once daily for 48 weeks

Drug: TMC125; darunavir; ritonavir

Interventions

TMC125; darunavir; ritonavir DRUG

TMC125 400mg once daily for 4 weeks; Darunavir-800mg once daily for 48 weeks; Ritonavir-100mg once daily 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 infection
• Naive to antiretroviral therapy (never received antiretroviral therapy prior to study)
• In the opinion of the investigator, have an indication for antiretroviral therapy
• Able to comply with the protocol requirements

You may not qualify if:

• No previous or current use of antiretroviral medications (ARVs) for the treatment of HIV infection or hepatitis B/C infection with anti-HIV activity
• No evidence of antiretroviral resistance on current or past resistance assays
• No chronic hepatitis B and/or C co-infection
• No grade 3 or 4 laboratory abnormality as defined by National Institute of Allergy and Infectious Diseases Division of Acquired Immunodeficiency Syndrome (DAIDS) grading tables, or a calculated creatinine clearance (CLCr) \< 50 mL/min.
• No known diabetes mellitus or hyperlipidemia requiring lipid-lowering therapy
• No acute viral hepatitis including, but not limited to A, B, or C.

Sponsors & Collaborators

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

Related Publications (1)

• DeJesus E, Lalezari JP, Osiyemi OO, Ruane PJ, Ryan R, Kakuda TN, Witek J. Pharmacokinetics of once-daily etravirine without and with once-daily darunavir/ritonavir in antiretroviral-naive HIV type-1-infected adults. Antivir Ther. 2010;15(5):711-20. doi: 10.3851/IMP1562.

  PMID: 20710052 DERIVED

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

Results Point of Contact

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

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 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 21, 2007
• First Posted: September 24, 2007
• Study Start: January 1, 2008
• Primary Completion: May 1, 2008
• Study Completion: March 1, 2009
• Last Updated: April 16, 2015
• Results First Posted: April 12, 2010

Record last verified: 2015-03