Atazanavir/Ritonavir and Darunavir/Ritonavir PK Tail Study - Full Text View

Purpose

The purpose of the study is to look at the levels of three HIV medications darunavir, ritonavir and atazanavir in the blood after the drug intake has been stopped in order to understand how long these drugs persist in blood for. The study will specifically look at these three drugs blood levels after taking them for 10 days everyday.

The main objective is to provide information on the potential safety (in terms of preventing virological failure and the development of resistance)of delaying drug doses occasionally by providing information on the decline in drug concentration after dosing has stopped.

Condition	Intervention	Phase
HIV HIV Infections	Drug: darunavir/ritonavir then atazanavir/ritonavir	Phase 1

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Pharmacokinetics of Darunavir/Ritonavir Once Daily and Atazanavir/Ritonavir Once Daily Over 72 Hours Following Drug Intake Cessation

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Ritonavir Atazanavir Darunavir Atazanavir sulfate Darunavir ethanolate

U.S. FDA Resources

Further study details as provided by St Stephens Aids Trust:

Primary Outcome Measures:

Pharmacokinetics [ Time Frame: 30 days (excluding screening and follow-up) ] [ Designated as safety issue: No ]
To assess the pharmacokinetics of darunavir/ritonavir once daily and atazanavir/ritonavir once daily over 72 hours following drug intake cessation

Secondary Outcome Measures:

Inter-Subject Variability [ Time Frame: 30 days ] [ Designated as safety issue: No ]
To assess the inter subject variability in darunavir and atazanavir plasma concentrations over 72 hours following drug intake cessation.
Safety and Tolerability [ Time Frame: 30 day (excluding screening and follow up) ] [ Designated as safety issue: Yes ]
To assess the safety and tolerability of darunavir/ritonavir and atazanavir/ritonavir over 10 days of administration
Pharmacogenetics [ Time Frame: 30 day (excluding screening and follow up) ] [ Designated as safety issue: No ]
To investigate the association between genetic polymorphisms in drug disposition genes and drug exposure

Estimated Enrollment:	25
Study Start Date:	April 2010
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Everybody All Subjects will receive the same intervention	Drug: darunavir/ritonavir then atazanavir/ritonavir Phase 1: Oral darunavir/ritonavir 800/100 mg once daily for 10 days Phase 2: Oral atazanavir/ritonavir 300/100 mg once daily for 10 days Other Names: Prezista = TMC114 Norvir, Reyataz = BMS-232632

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria within 28 days prior to the baseline visit:

The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements
Male or non-pregnant, non-lactating females
Between 18 to 65 years, inclusive
Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive.
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least one month after the study

Exclusion Criteria:

Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.

Any significant acute or chronic medical illness
Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
Positive blood screen for hepatitis B surface antigen and/or C antibodies
Positive blood screen for HIV-1 and/or 2 antibodies
Current or recent (within 3 months) gastrointestinal disease
Clinically relevant alcohol or drug use (positive urine drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study
Exposure to any investigational drug or placebo within 3 months of first dose of study drug
Use of any other drugs (unless approved by the Investigator), including over-the-counter medications and herbal preparations, within two weeks prior to first dose of study drug
Females of childbearing potential without the use of effective non-hormonal birth control methods, or not willing to continue practising these birth control methods for at least 30 days after the end of the treatment period

19. Previous allergy to any of the constituents of the pharmaceuticals administered in this trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073761

Locations

United Kingdom
St Stephen's Centre
London, United Kingdom, SW10 9TH

Sponsors and Collaborators

St Stephens Aids Trust

Investigators

Principal Investigator:

Marta Boffito, Dr

St Stephen's AIDS Trust

More Information

No publications provided

Responsible Party:	Dr Marta Boffito, St Stephen's AIDS Trust
ClinicalTrials.gov Identifier:	NCT01073761 History of Changes
Other Study ID Numbers:	SSAT 034
Study First Received:	February 22, 2010
Last Updated:	August 13, 2010
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir

Atazanavir
Darunavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013