NCT00197639

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2006

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

November 15, 2010

Status Verified

November 1, 2010

Enrollment Period

2.7 years

First QC Date

September 13, 2005

Last Update Submit

November 10, 2010

Conditions

HIV Infection

Keywords

indinavir, HIV, ritonavir, pharmacokinetics, Thailand

Interventions

Ritonavir-boosted indinavirDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

HIV-infected Thai adults

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Prapokklao Hospital

Muang, Changwat Chanthaburi, 22000, Thailand

Location

Chonburi Hospital

Muang, Changwat Chon Buri, 20000, Thailand

Location

Phayao Provincial Hospital

Muang, Changwat Phayao, 56000, Thailand

Location

Nakornping Hospital

Mae Rim, Chiang Mai, 50180, Thailand

Location

Related Publications (1)

  • 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. doi: 10.1093/jac/dki143. Epub 2005 May 9.

    PMID: 15883177BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Marc Lallemant

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

September 1, 2006

Primary Completion

May 1, 2009

Study Completion

August 1, 2010

Last Updated

November 15, 2010

Record last verified: 2010-11

Locations

TH(4)