Status:
COMPLETED
Pharmacokinetic Study of Indinavir Drug Levels When Boosted With Ritonavir in Thailand
Lead Sponsor:
Harvard School of Public Health (HSPH)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infection
Eligibility:
All Genders
18-60 years
Brief Summary
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.
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, "M...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00197639
Start Date
September 1 2006
End Date
August 1 2010
Last Update
November 15 2010
Active Locations (4)
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1
Prapokklao Hospital
Muang, Changwat Chanthaburi, Thailand, 22000
2
Chonburi Hospital
Muang, Changwat Chon Buri, Thailand, 20000
3
Phayao Provincial Hospital
Muang, Changwat Phayao, Thailand, 56000
4
Nakornping Hospital
Mae Rim, Chiang Mai, Thailand, 50180