NCT00622206

Brief Summary

Compare the Pharmacokinetics of ritonavir and saquinavir(using either Saquinavir /Ritonavir 1500/100 mg or 1500/50 mg) Evaluate short term tolerability, safety and toxicity Evaluate if there is any relation between RTV concentration levels and boosting effect

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_1 hiv-infections

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 12, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

April 5, 2012

Status Verified

April 1, 2012

Enrollment Period

3 months

First QC Date

February 12, 2008

Last Update Submit

April 3, 2012

Conditions

HIV Infections

Keywords

Pharmacokineticsritonavirsaquinavirsafety and toxicitytreatment experienced

Outcome Measures

Primary Outcomes (1)

  • To compare the Pharmacokinetics od ritonavir and saquinavir in Thai HIV-1 infected subjects using either Saquinavir /Ritonavir 1500/100 mg or 1500/50 mg

    6 months and 1 week

Secondary Outcomes (1)

  • Evaluate short term tolerability, safety and toxicity of this treatment strategy Evaluate if there is any relation between RTV concentration levels and boosting effect

    6 months and 1 week

Study Arms (1)

1

ACTIVE COMPARATOR

Twenty HIV-infected volunteers on stable doses of SQV/RTV 1500/100 mg OD for at least 3 months with an NRTI backbone and undetectable viral load will participate. After collecting samples for a full PK curve subjects will be switched to SQV/RTV 1500 /50 mg OD + 2NRTIs for 1 week before repeating the PK assessment. Blood samples will be drawn at T 0, 1, 2, 4, 6, 8, 10, 12 and 24 hours post ingestion. Consecutively to the assessment, subjects will return to SQV/RTV 1500/100 mg OD dosage.

Drug: ritonavir and saquinavir

Interventions

ritonavir and saquinavirDRUG

saquinavir/ritonavir 1500/100 mg or 1500/50 mg Twenty HIV-infected volunteers on stable doses of SQV/RTV 1500/100 mg OD for at least 3 months with an NRTI backbone and undetectable viral load will participate. After collecting samples for a full PK curve subjects will be switched to SQV/RTV 1500 /50 mg OD + 2NRTIs for 1 week before repeating the PK assessment. Blood samples will be drawn at T 0, 1, 2, 4, 6, 8, 10, 12 and 24 hours post ingestion. Consecutively to the assessment, subjects will return to SQV/RTV 1500/100 mg OD dosage.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Documented positive test for HIV-1 infection
  • HIV RNA viral load 50 \< copies for at least 3 months
  • Written informed consent
  • On a Saquinavir 1500 mg based HAART regimen for at least 3 months

You may not qualify if:

  • Pregnant or lactating
  • Use of concomitant medication that may interfere with the pharmacokinetics of saquinavir/ritonavir
  • Inability to understand the nature and extent of the study and the procedures required
  • ALT/ AST more than 5x upper limit
  • Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HIV-NAT

Bangkok, Bangkok, 10330, Thailand

Location

Related Publications (1)

  • Avihingsanon A, van der Lugt J, Kerr SJ, Gorowara M, Chanmano S, Ohata P, Lange J, Cooper DA, Phanuphak P, Burger DM, Ruxrungtham K. A low dose of ritonavir-boosted atazanavir provides adequate pharmacokinetic parameters in HIV-1-infected Thai adults. Clin Pharmacol Ther. 2009 Apr;85(4):402-8. doi: 10.1038/clpt.2008.244. Epub 2008 Dec 31.

    PMID: 19118378RESULT

Related Links

MeSH Terms

Conditions

HIV Infections

Interventions

RitonavirSaquinavir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingQuinolines

Study Officials

  • Kiat Ruxrungtham, MD

    The HIV Netherlands Australia Thailand Research Collaboration

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2008

First Posted

February 22, 2008

Study Start

January 1, 2008

Primary Completion

April 1, 2008

Study Completion

August 1, 2008

Last Updated

April 5, 2012

Record last verified: 2012-04

Locations

TH(1)