TMC114-TiDP3-C181: Study to Assess the Pharmacokinetics of Darunavir (DRV) With Different Doses of Ritonavir in Healthy Volunteers.

NCT00744887 | Completed Phase 1

• 1 other identifier: CR015421
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objectives are to determine the effect of different ritonavir doses on darunavir (DRV) oral exposure following once-daily oral dosing of DRV/rtv for 7 days, in order to establish an optimal ritonavir boosting dose for DRV and to evaluate short-term safety and tolerability.

Conditions

HIV; AIDS

Keywords

TMC114-TiDP3-C181; TMC114-C181, health volunteers, Darunavir, ritonavir oral solution

Outcome Measures

Primary Outcomes (1)

• To determine the effect of different ritonavir doses (20, 50, 100 mg ritonavir) in DRV oral exposure following once-daily oral dosing of DRV/rtv for 7 days, in order to establish an optimal ritonavir boosting dose for DRV

Secondary Outcomes (1)

• To evaluate short-term safety and tolerability of DRV following administration of DRV 800 mg once-daily in the presence of different doses of ritonavir for 7 days in healthy volunteers

Interventions

Darunavir DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, electrocardiogram (ECG), vital signs, and the results of blood biochemistry, blood coagulation and hematology tests and a urinalysis carried out at screening

You may not qualify if:

• A positive HIV-1 or HIV-2 test at screening
• Hepatitis A, B, or C infection (confirmed by hepatitis A antibody IgM, hepatitis B surface antigen \[with a positive hep B PCR\], or hepatitis C virus antibody, respectively) at Screening
• Any history of significant skin disease such as, but not limited to, rash or eruptions, food or drug allergy, dermatitis, eczema, psoriasis, folliculitis, or urticaria
• Use of concomitant medication, including over-the-counter products, herbal preparations and dietary supplements. Concomitant medication must have been discontinued at least 14 days before the first dose of trial medication except for paracetamol (acetaminophen), hormone replacement therapy and hormonal contraceptives
• Participation in an investigational drug trial within 60 days prior to the first intake of trial medication.

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

Related Links

• Clinical Study Report Synopsis of TMC114-TiDP3-C181: an open-label, randomized, 3-way crossover trial to assess the pharmacokinetics of darunavir (DRV) given once-daily with different doses of ritonavir in healthy subjects.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Darunavir

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

Study Officials

• Tibotec Pharmaceuticals Clinical Trial

  Tibotec Pharmaceutical Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 29, 2008
• First Posted: September 1, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 9, 2011

Record last verified: 2010-04