NCT01138202

Brief Summary

To assess safety, efficacy and impact of Lopinavir/ritonavir 400/100mg bid or Lopinavir/ritonavir 600/150mg bid in combination with rifampicin-containing anti-TB therapy.

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_2 hiv-infections

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_2 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

First Submitted

Initial submission to the registry

June 4, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

5.1 years

First QC Date

June 4, 2010

Last Update Submit

July 15, 2020

Conditions

HIV InfectionsTuberculosis

Keywords

pharmacokineticssafetyefficacyLopinavir/ritonavirHIV/TBrifampicin containing anti-tuberculosis therapyPharmacokinetics and safety of Lopinavir/ritonavir with rifampicin containing anti-tuberculosis therapy

Outcome Measures

Primary Outcomes (1)

  • plasma concentration level

    Percentage of plasma concentration level above an acceptable lower limit (lopinavir Cmin \> 1 mg/L) at steady-state.

    12 hours

Secondary Outcomes (4)

  • identify toxicities

    48 weeks

  • CD4

    48 weeks

  • HIV RNA

    48 weeks

  • genotypic resistant

    48 weeks

Study Arms (2)

1

EXPERIMENTAL

boosted LPV/r 400/100 mg BID + 2 NRTI

Drug: LPV/r

2

EXPERIMENTAL

boosted LPV/r 600/150 mg BID + 2 NRTI

Drug: LPV/r

Interventions

LPV/rDRUG

LPV/r 400/100 mg BID + 2 NRTI for arm 1 (total 48 weeks) LPV/r 600/150 mg BID + 2 NRTI for arm 2 (total 48 weeks)

12

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Confirmed HIV positive after voluntary counseling and testing
  • Aged \>18-60years of age
  • ARV naïve and NNRTI failure ( PI naive)
  • CD4+ cell count of \<350 cells/mm3 at the time of diagnosed TB
  • ALT \<5 times ULN
  • Serum creatinine \<1.4 mg/dl
  • Hemoglobin \>8 mg/L
  • TB is diagnosed and planned to receive stable doses of rifampicin-containing anti-TB therapy for at least a 2 week period after initiation of ART
  • No other active OI (CDC class C event), except oral candidiasis or disseminated MAC
  • Able to provide written informed consent

You may not qualify if:

  • Current use of steroid (except short course steroid for IRIS) and other immunosuppressive agents.
  • Current use of any prohibited medications related to drug pharmacokinetics.
  • Patients with current alcohol or illicit substance use that in the opinion of the site Principal Investigator would conflict with any aspect of the conduct of the trial.
  • Unlikely to be able to remain in follow-up for the protocol defined period.
  • Patients with proven or suspected acute hepatitis. Patients with chronic viral hepatitis are eligible provided ALT, AST \< 5 x ULN.
  • Karnofsky performance score \<30%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HIV-NAT Thai Red Cross AIDS Research Center

Bangkok, 10330, Thailand

Location

Related Links

MeSH Terms

Conditions

HIV InfectionsTuberculosis

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Study Officials

  • Anchalee Avihingsanon, MD

    The HIV Netherlands Australia Thailand Research Collaboration

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2010

First Posted

June 7, 2010

Study Start

November 1, 2010

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 17, 2020

Record last verified: 2020-07

Locations

TH(1)