- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00197639
Pharmacokinetic Study of Indinavir Drug Levels When Boosted With Ritonavir in Thailand
November 10, 2010 updated by: Harvard School of Public Health (HSPH)
A Pharmacokinetic Study to Assess the Inter-patient Variability of Indinavir Drug Levels When Boosted With Ritonavir in Thai Patients on Highly Active Antiretroviral Therapy
This study looks at the ways indinavir drug levels, when boosted with ritonavir, may vary from patient to patient.
The study population are HIV+ Thai individuals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will assess the inter-individual variability of indinavir drug levels, boosted with ritonavir, in Thai patients.
Data will be collected in patients participating in the randomized study, "Monitoring Highly Active Antiretroviral Therapy (HAART) in HIV-infected patients in Thailand (PHPT-3)" (HSC 10668).
The first 20 patents in PHPT-3 will have steady-state pharmacokinetic sparse sampling performed at pre-dose, and 1, 2.5, 4 and 12 hours after drug intake 1 and 2 months after initiating IDV/r 400/100 mg, twice daily.
IDV/r plasma concentrations will be determined by high performance liquid chromatography.
This spare PK data will be pooled with indinavir concentration data collected within an intensive pharmacokinetic studies of IDV/r [Cressey TR, et al 2005, JAC, 55, p1041-44].
Population means and variances of indinavir and ritonavir pharmacokinetic parameters were estimated using non-linear mixed effects regression models (NONMEM Version VI).
The validity of the final model was evaluated using a visual predictive check (VPC) and bootstrap re-sampling techniques.
Study Type
Observational
Enrollment (Actual)
19
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Chanthaburi
-
Muang, Chanthaburi, Thailand, 22000
- Prapokklao Hospital
-
-
Chiang Mai
-
Mae Rim, Chiang Mai, Thailand, 50180
- Nakornping Hospital
-
-
Chonburi
-
Muang, Chonburi, Thailand, 20000
- Chonburi Hospital
-
-
Phayao
-
Muang, Phayao, Thailand, 56000
- Phayao Provincial Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
HIV-infected Thai adults
Description
Inclusion Criteria:
- Subjects enrolled in the parent study, "Monitoring HAART Therapy in HIV-Infected Patients in Thailand (PHPT-3)" and agreeing to additional blood sampling and tests.
Exclusion Criteria:
- Current active substance or alcohol abuse
- Active opportunistic infection
- Chronic malabsorption or diarrhea
- Other clinically significant disease
- Certain lab values (e.g. hemoglobin < 8.0 mg/dL)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Marc Lallemant, Harvard School of Public Health (HSPH)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
November 15, 2010
Last Update Submitted That Met QC Criteria
November 10, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Ritonavir
- Indinavir
Other Study ID Numbers
- HSC 10913
- R01HD042964 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infection
-
Erasmus Medical CenterNot yet recruitingHIV Infections | Hiv | HIV-1-infection | HIV I InfectionNetherlands
-
Sociedad Andaluza de Enfermedades InfecciosasConsejeria de Salud. Junta de Andalucia. SpainCompletedHIV Infection | HIV-1 InfectionSpain
-
Allegheny Singer Research Institute (also known...Active, not recruitingHIV Infections | HIV-1-infection | HIV I InfectionUnited States
-
Beckman Coulter, Inc.CompletedHIV I Infection | HIV-2 InfectionFrance
-
Rockefeller UniversityCompletedHIV Infection | Healthy Volunteers | HIV-1 InfectionUnited States
-
Erasmus Medical CenterRecruitingHIV Infections | HIV-1-infection | HIV-2 InfectionNetherlands
-
Erasmus Medical CenterActive, not recruitingHIV Infections | HIV-1-infection | HIV-2 InfectionNetherlands
-
AIDS Healthcare FoundationUniversity of California, Los AngelesCompleted
-
Merck Sharp & Dohme LLCCompleted
-
Northwestern UniversityPfizer; Tibotec, IncCompletedHIV Infections | HIV-1 InfectionUnited States
Clinical Trials on Ritonavir-boosted indinavir
-
The HIV Netherlands Australia Thailand Research...Ministry of Education, ThailandCompletedHIV Infections | HIV InfectionThailand
-
University of California, San FranciscoCompleted
-
The University of Texas Health Science Center,...Completed
-
GlaxoSmithKlineCompletedHIV Infection | Infection, Human Immunodeficiency VirusUnited States, Puerto Rico
-
The HIV Netherlands Australia Thailand Research...CompletedHIV Infections | TuberculosisThailand
-
Fundacion SEIMC-GESIDABristol-Myers SquibbCompleted
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedHIV InfectionsUnited States, Puerto Rico
-
Emory UniversityCompletedHIV InfectionsUnited States
-
Juan A. ArnaizCompletedHIV | HypercholesterolaemiaSpain
-
National Institute of Allergy and Infectious Diseases...CompletedHIV InfectionsUnited States, Puerto Rico