NCT01014481

Brief Summary

To study the optimal timing to initiate antiretroviral therapy in HIV-infected patients who are receiving tuberculosis treatment between at 4 weeks and at 12 weeks after tuberculosis treatment by comparing the composite end point of death rate, hospitalization rate and adverse drug reactions at week 48, 96 and 144.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
156

participants targeted

Target at P50-P75 for phase_4 hiv-infections

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_4 hiv-infections

Geographic Reach
1 country

1 active site

Status
terminated

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

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

November 17, 2011

Status Verified

November 1, 2011

Enrollment Period

1.6 years

First QC Date

November 16, 2009

Last Update Submit

November 16, 2011

Conditions

HIV InfectionsTuberculosis

Keywords

HIVtuberculosisantiretroviral treatmenttiming

Outcome Measures

Primary Outcomes (1)

  • death rate

    48 weeeks

Secondary Outcomes (5)

  • hospitalization

    48 weeks

  • adverse events

    48 weeks

  • composite endpoint of a. death b. hospitalization and c. adverse event

    48 weeks

  • TB IRIS

    48 weeks

  • Risk of death

    48 weeks

Study Arms (1)

start antiretroviral treatment

EXPERIMENTAL

the optimal timing to initiate antiretroviral therapy in HIV-infected patients who are receiving tuberculosis treatment between at 4 weeks and at 12 weeks after tuberculosis treatment

Drug: tenofovir, lamivudine, efavirenz

Interventions

tenofovir, lamivudine, efavirenzDRUG

initiate tenofovir 300 mg/day, lamivudine 300 mg/day, efavirenz 600 mg/day between at 4 weeks and at 12 weeks after tuberculosis treatment

Also known as: at 4 weeks versus at 12 weeks after tuberculosis treatment
start antiretroviral treatment

Eligibility Criteria

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

You may qualify if:

  • years of age
  • HIV-1 infected patients
  • Naïve to antiretroviral treatment
  • Baseline CD4 cell count \<350 cells/mm3 at enrolment
  • Diagnosed as having active tuberculosis by clinical features or positive acid fast stain or positive TB culture; and receiving rifampicin containing antituberculous regimen
  • Signed inform consent

You may not qualify if:

  • Serum transaminase enzymes ≥ 5 times of upper normal limit or total bilirubin ≥ 3 times of upper normal limit
  • Serum creatinine ≥ 2 times of upper normal limit
  • Lactation or pregnancy
  • Receiving any immunosuppressive agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health

Nonthaburi, Changwat Nonthaburi, 11000, Thailand

Location

Related Publications (1)

  • Kiertiburanakul S, Manosuthi W, Sungkanuparph S. Optimal timing of antiretroviral therapy initiation in patients coinfected with HIV and tuberculosis. Expert Rev Clin Pharmacol. 2011 Mar;4(2):143-6. doi: 10.1586/ecp.11.2. No abstract available.

    PMID: 22115397DERIVED

MeSH Terms

Conditions

HIV InfectionsTuberculosis

Interventions

TenofovirLamivudineefavirenz

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)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosides

Study Officials

  • Weerawat Manosuthi, MD

    Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health, Nonthaburi, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 16, 2009

First Posted

November 17, 2009

Study Start

October 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

November 17, 2011

Record last verified: 2011-11

Locations

TH(1)