NCT01002898

Brief Summary

To assess 48-week treatment responses, tolerability, and steady-state minimum plasma concentrations of ritonavir-boosted lopinavir monotherapy for salvage therapy in HIV-1 infected patients who failed antiretroviral regimens containing NRTI and NNRTI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_3 hiv

Timeline
Completed

Started Apr 2007

Typical duration for phase_3 hiv

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

April 1, 2007

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

November 11, 2011

Status Verified

October 1, 2009

Enrollment Period

3.8 years

First QC Date

October 27, 2009

Last Update Submit

November 10, 2011

Conditions

HIV

Keywords

HIV-1 RNATreatment experienced

Outcome Measures

Primary Outcomes (1)

  • To assess 48-week treatment responses of ritonavir-boosted lopinavir (LPV/r) monotherapy as salvage regimen.

    48 weeks

Study Arms (1)

lopinavir/ritonavir

EXPERIMENTAL
Drug: lopinavir/ritonavir soft gel capsule

Interventions

lopinavir/ritonavir soft gel capsuleDRUG

Ritonavir-boosted lopinavir in soft gel formulation at 400/100 mg and lamivudine at 150 mg were given twice daily.

Also known as: Kaletra
lopinavir/ritonavir

Eligibility Criteria

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

You may qualify if:

  • HIV-1 infected patients \>18 years of age,
  • failed NNRTI-based antiretroviral therapy with M184V, thymidine analogue mutations (TAMs) and NNRTI-associated mutations
  • had plasma HIV-1 RNA \>1,000 copies/mL.

You may not qualify if:

  • Had a history of exposure to protease inhibitor
  • Receipt a medication that has drug-drug interactions with lopinavir.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bamrasnaradura Infectious Diseases Institute

Nonthaburi, Changwat Nonthaburi, 11000, Thailand

Location

MeSH Terms

Interventions

Lopinavirlopinavir-ritonavir drug combination

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

October 27, 2009

First Posted

October 28, 2009

Study Start

April 1, 2007

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

November 11, 2011

Record last verified: 2009-10

Locations

TH(1)