Appropriate Timing of HAART in Co-infected HIV/TB Patients | NCT01014481

Studies
Appropriate Timing of HAART in Co-infected HIV/TB Patients

NCT01014481

Sponsor

Bamrasnaradura Infectious Diseases Institute

Status

Terminated

Last Update Posted

Nov 17, 2011Estimated

Enrollment

156Actual

Phase

Phase 4

Conditions

HIV Infections
Tuberculosis

Interventions

tenofovir, lamivudine, efavirenz

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

this study was ended prematurely by ethical committees with a reason of the final outcome was achieved with no longer recruitment was needed.

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Nov 16, 2009

First Submission Date that Met QC Criteria

Nov 16, 2009

First Posted Date

Nov 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2011

Last Update Posted Date

Nov 17, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Bamrasnaradura Infectious Diseases InstituteOTHER_GOV

Collaborators

Name	Class
Mahidol University	OTHER
Thai Red Cross AIDS Research Centre	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The growing epidemic of HIV poses a serious public health threat in many countries, including Thailand. Mortality is clearly reduced in HIV and tuberculosis (TB) co-infected patients who initiate antiretroviral therapy (ART) after the treatment of TB, but the optimal timing to initiate ART is one of the major concern for patients concurrently receiving both therapies. To date, the prospective, randomized, control trial to study the optimal timing to initiate ART in the patients is still limited. In addition, the current recommendation to start ART in patients co-infected with HIV and TB is still based on expert opinions. Here, the investigators plan to investigate 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 at Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health, Nonthaburi, Thailand.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

156Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
tenofovir, lamivudine, efavirenz	Drug	initiate tenofovir 300 mg/day, lamivudine 300 mg/day, efavirenz 600 mg/day between at 4 weeks and at 12 weeks after tuberculosis treatment	start antiretroviral treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
death rate		48 weeeks

Secondary Outcomes

Measure	Description	Time Frame
hospitalization		48 weeks
adverse events		48 weeks
composite endpoint of a. death b. hospitalization and c. adverse event

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-65 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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Weerawat Manosuthi, MD	Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health, Nonthaburi, Thailand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health		Nonthaburi	Changwat Nonthaburi	11000	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22115397	Derived	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.

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

ID	Term
D000068698	Tenofovir
D019259	Lamivudine
C098320	efavirenz

ID	Term
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals
D000225	Adenine

ID	Term
D015658	HIV Infections
D014376	Tuberculosis