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

This study is currently recruiting participants.

Verified by Harvard School of Public Health, September 2006

Sponsored by:	Harvard School of Public Health
Information provided by:	Harvard School of Public Health
ClinicalTrials.gov Identifier:	NCT00197639

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

MedlinePlus related topics: AIDS

Drug Information available for: Indinavir Indinavir Sulfate Ritonavir

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cross-Sectional, Defined Population, Prospective Study
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

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

Estimated Enrollment:	20
Study Start Date:	September 2006

Detailed Description:

This study assess the inter-individual variability of indinavir drug levels, boosted with ritonavir, in Thai patients. Data will be collected in 20 patients participating in the randomized study, "Monitoring Highly Active Antiretroviral Therapy (HAART) in HIV-infected patients in Thailand" (HSC 10668)and consenting to participate in this substudy.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

Contacts

Contact: Marc Lallemant, MD	+66 53 814633	Marc@phpt.org
Contact: Gonzague Jourdain, MD	+66 53 814633	gonzague@phpt.org

Locations

Thailand, Chanthaburi
Prapokklao Hospital	Recruiting
Muang, Chanthaburi, Thailand, 22000
Contact: Norawee Chuachamsai, MD +66 39 324 975
Thailand, Chiang Mai
Nakornping Hospital	Recruiting
Mae Rim, Chiang Mai, Thailand, 50180
Contact: Prattana Leenasirimakul, MD +66 53 890 755-64
Thailand, Chiangrai
Chiangrai Prachanukroh Hospital	Recruiting
Muang, Chiangrai, Thailand, 57000
Contact: Pacharee Kantipong, MD +66 53 711 300
Thailand, Chonburi
Chonburi Hospital	Recruiting
Muang, Chonburi, Thailand, 20000
Contact: Chureeratana Bowonwatanuwong, MD +66 38 274 200-7
Thailand, Phayao
Phayao Provincial Hospital	Recruiting
Muang, Phayao, Thailand, 56000
Contact: Guttiga Halue, MD +66 54 410 501-11

Sponsors and Collaborators

Harvard School of Public Health

Investigators

Principal Investigator:

Marc Lallemant

Harvard School of Public Health

More Information

Publications:

Cressey TR, Leenasirimakul P, Jourdain G, Tod M, Sukrakanchana PO, Kunkeaw S, Puttimit C, Lallemant M. Low-doses of indinavir boosted with ritonavir in HIV-infected Thai patients: pharmacokinetics, efficacy and tolerability. J Antimicrob Chemother. 2005 Jun;55(6):1041-4. Epub 2005 May 9.

Study ID Numbers:	HSC 10913
Study First Received:	September 13, 2005
Last Updated:	September 20, 2006
ClinicalTrials.gov Identifier:	NCT00197639
Health Authority:	Thailand: Ministry of Public Health

Keywords provided by Harvard School of Public Health:

indinavir, HIV, ritonavir, pharmacokinetics, Thailand

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Indinavir
Ritonavir
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on January 16, 2009