NCT00433719

Brief Summary

The optimal time to initiate antiretroviral therapy (ART) in HIV-associated tuberculous meningitis (TBM) unknown. There are concerns that immediate ART may worsen rather than improve outcome, because drug interactiond and toxicities or development of an intracerebral immune reconstitution inflammatory syndrome (IRIS). Conversely, delaying ART may result in increased HIV-related deaths. To answer this question, we are conducting a randomised, double-blind placebo-controlled trial comparing immediate and deferred ART in HIV-infected patients presenting with TBM, to assess effect on survival.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
253

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Sep 2005

Typical duration for not_applicable hiv-infections

Geographic Reach
1 country

2 active sites

Status
unknown

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

September 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2007

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 12, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

August 7, 2008

Status Verified

June 1, 2008

Enrollment Period

3.3 years

First QC Date

January 25, 2007

Last Update Submit

August 6, 2008

Conditions

HIV InfectionsTuberculous Meningitis

Keywords

Human immunodeficiency virusTuberculous meningitisTreatment Naive

Outcome Measures

Primary Outcomes (1)

  • Mortality

    9 months

Secondary Outcomes (7)

  • Mortality

    12 months

  • Fever clearance time

  • Coma clearance time

  • CD4 count

    12 months

  • plasma HIV RNA

    12 months

  • +2 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Combivir, efavirenz for 12 months

Drug: Combivir and efavirenz

2

PLACEBO COMPARATOR

Placebo for 2 months followed by Combivir and efavirenz for 10 months

Drug: Combivir and efavirenz

Interventions

Combivir and efavirenzDRUG

Arm 1: Combivir and efavirenz for 12 months Arm 2: Placebo for 2 months then Combivir and efavirenz for 10 months

12

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • age 15 years or older
  • HIV antibody positive
  • clinical diagnosis of TB meningitis

You may not qualify if:

  • positive CSF Gram or India ink stain
  • known or suspected pregnancy
  • antituberculous treatment 8 - 30 days immediately prior to recruitment
  • previous antiretroviral therapy
  • laboratory contraindications to antiretroviral or antituberculous therapy
  • lack of consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital for Tropical Diseases

Ho Chi Minh City, Vietnam

Location

Pham Ngoc Thach Hospital

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

HIV InfectionsTuberculosis, MeningealAcquired Immunodeficiency Syndrome

Interventions

lamivudine, zidovudine drug combinationefavirenz

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesMeningitis, BacterialCentral Nervous System Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesTuberculosis, Central Nervous SystemTuberculosis, ExtrapulmonaryTuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesMeningitisNeuroinflammatory DiseasesSlow Virus Diseases

Study Officials

  • Estee Torok

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 25, 2007

First Posted

February 12, 2007

Study Start

September 1, 2005

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

August 7, 2008

Record last verified: 2008-06

Locations

VN(2)