Pharmacokinetic Study of Indinavir Drug Levels When Boosted With Ritonavir in Thailand

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT00197639
First received: September 13, 2005
Last updated: November 10, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention
HIV Infection
Drug: Ritonavir-boosted indinavir

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Harvard School of Public Health:

Enrollment: 19
Study Start Date: September 2006
Study Completion Date: August 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HIV-infected Thai adults

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197639

Locations
Thailand
Prapokklao Hospital
Muang, Chanthaburi, Thailand, 22000
Nakornping Hospital
Mae Rim, Chiang Mai, Thailand, 50180
Chonburi Hospital
Muang, Chonburi, Thailand, 20000
Phayao Provincial Hospital
Muang, Phayao, Thailand, 56000
Sponsors and Collaborators
Harvard School of Public Health
Investigators
Principal Investigator: Marc Lallemant Harvard School of Public Health
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00197639     History of Changes
Other Study ID Numbers: HSC 10913, R01HD042964
Study First Received: September 13, 2005
Last Updated: November 10, 2010
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Harvard School of Public Health:
indinavir, HIV, ritonavir, pharmacokinetics, Thailand

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
Indinavir
Ritonavir
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 July 28, 2014