NCT00411996

Brief Summary

We believe that there is a strong rationale for the study of IDV/r 600/100 bid as a boosted-PI combination that, in the presence of RMP, is able to produce a satisfactory PK profile associated with adequate antiretroviral potency, tolerability and efficacy.

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 Dec 2006

Typical duration 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

December 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

1.8 years

First QC Date

December 14, 2006

Last Update Submit

July 15, 2020

Conditions

HIV InfectionsTuberculosis

Keywords

indinavir/ritonavirHIV/TBrifampicinPK and efficacy of IDV/RTV 600/100 mg BID with rifampicinTreatment Naive

Outcome Measures

Primary Outcomes (1)

  • pharmacokinetics of ritonavir-boosted indinavir 600/100mg bid in combination with rifampicin-containing anti-TB therapy.

    2 weeks

Secondary Outcomes (3)

  • safety of ritonavir-boosted indinavir 600/100mg bid in combination with rifampicin-containing anti-TB therapy

    48 weeks

  • efficacy of ritonavir-boosted indinavir 600/100mg bid in combination with rifampicin-containing anti-TB therapy

    48 weeks

  • the prevalence of immune recovery syndrome of TB and other HIV-related conditions after ritonavir-boosted indinavir 600/100mg bid

    48 weeks

Study Arms (1)

1

OTHER

IDV/r 600/100 mg + rifampicin

Drug: indinavir/ritonavir

Interventions

indinavir/ritonavirDRUG

IDV/r 600/100 mg BID + rifampicin OD for at least 2 weeks

1

Eligibility Criteria

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

You may qualify if:

  • Confirmed HIV positive after voluntary counselling and testing
  • Aged between 18 and 60 years of age
  • Antiretroviral treatment naive
  • CD4+ cell count of \<200 cells/mm3 at the time of TB diagnosis
  • ALT \<5 times ULN
  • Serum creatinine \<1.4 mg/dl
  • Haemoglobin \>8 mg/L
  • TB diagnosis; either probable (clinical symptoms plus chest x-ray and response to anti-TB medication) or definitive( sputum AFB culture confirmed) and receiving or planning to receive rifampicin-containing anti-TB therapy for at least a 2 week period before the initiation of ART
  • No other active OI (CDC class C event)
  • Able to provide written informed consent

You may not qualify if:

  • Current use of steroids and other immunosuppressive agents
  • Current use of any prohibited medications related to compliance and 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.
  • Previous exposure to nevirapine monotherapy
  • 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 Publications (1)

  • Avihingsanon A, van der Lugt J, Singphore U, Gorowara M, Boyd M, Ananworanich J, Phanuphak P, Burger D, Ruxrungtham K. Pharmacokinetics and 48 week efficacy of adjusted dose indinavir/ritonavir in rifampicin-treated HIV/tuberculosis-coinfected patients: a pilot study. AIDS Res Hum Retroviruses. 2012 Oct;28(10):1170-6. doi: 10.1089/AID.2011.0247. Epub 2012 Mar 6.

    PMID: 22250979DERIVED

Related Links

MeSH Terms

Conditions

HIV InfectionsTuberculosis

Interventions

IndinavirRitonavir

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

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolesSulfur CompoundsOrganic ChemicalsAzoles

Study Officials

  • Kiat Ruxrungtham, MD

    HIV-NAT, Thai Red Cross AIDS Research Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 14, 2006

First Posted

December 15, 2006

Study Start

December 1, 2006

Primary Completion

October 1, 2008

Study Completion

December 1, 2009

Last Updated

July 17, 2020

Record last verified: 2020-07

Locations

TH(1)