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REMEMBER: Reducing Early Mortality & Morbidity by Empiric Tuberculosis (TB) Treatment (REMEMBER)

Primary Purpose

HIV Infection

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Atripla (r)
Efavirenz
Truvada
Rifampin/isoniazid/pyrazinamide/ethambutol FDC
Rifampin/isoniazid FDC
Isoniazid
Sponsored by
AIDS Clinical Trials Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV-1 infection
  • Willingness to start efavirenz-based ART as soon as possible and within no more than 3 days following randomization.
  • CD4+ cell count <50 cells/mm^3 obtained within 45 days prior to study entry
  • Aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), and total bilirubin ≤ 2.5 X ULN within 30 days prior to study entry.
  • Creatinine clearance ≥30 mL/min either measured or estimated using values obtained within 30 days prior to study entry.
  • Results from a hepatitis B surface antigen test performed within 30 days prior to study entry.
  • Agreement not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization).
  • Female candidates of reproductive potential must have a negative serum or urine (15-25 mIU/mL) pregnancy test result within 7 days prior to study entry.
  • Female candidates of reproductive potential who are participating in sexual activity that could lead to pregnancy must use two reliable methods of contraception while on study.
  • Karnofsky performance score >/= 30 at time of study entry.
  • Ability to swallow medications.
  • Ability and willingness of participant or legal guardian/representative to provide informed consent.
  • Intention to remain in the same general geographic region for the duration of study participation.

Exclusion Criteria:

  • Presence of any confirmed or probable TB based on criteria listed in the current ACTG diagnosis appendix within 30 days prior to study entry and following completion of study-specific screening algorithm.
  • Use of single-dose NVP for prevention of mother-to-child transmission (pMTCT) within 24 months prior to study entry.
  • Use of prohibited medications within 30 days prior to study entry.
  • Known allergy/sensitivity or any hypersensitivity to components of study-required ART or TB treatment.
  • Current receipt of treatment for active TB or receipt of >14 days cumulative treatment for active TB within 96 weeks prior to study entry.
  • Receipt of >30 days cumulative of INH prophylaxis within 48 weeks prior to study entry.
  • Receipt at any time prior to study entry of >7 days cumulative treatment with any ARV or combination of ARVs (except for ARVs taken for any length of time during pregnancy for pMTCT, or ARVs taken for occupational exposure).
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Current Grade ≥2 neuropathy.
  • History of multi-drug-resistant (MDR) TB.
  • Within 12 weeks prior to entry, exposure to a household member or co-worker with known MDR TB.

Sites / Locations

  • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
  • GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS
  • Les Centres GHESKIO CRS
  • YRG CARE Medical Ctr., VHS Chennai CRS
  • BJ Medical College CRS
  • AMPATH at Moi Univ. Teaching Hosp. Eldoret CRS
  • Walter Reed Project - Kenya Med. Research Institute Kericho CRS
  • College of Med. JHU CRS (30301)
  • University of North Carolina Lilongwe CRS (12001)
  • San Miguel CRS
  • Barranco CRS (11301)
  • Wits HIV CRS
  • CAPRISA eThekwini CRS
  • Durban Adult HIV CRS
  • Soweto ACTG CRS (12301)
  • Joint Clinical Research Centre (JCRC) (12401)
  • Kalingalinga Clinic CRS (12801)
  • UZ-Parirenyatwa CRS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A: Empiric

Arm B: IPT

Arm Description

Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only

Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).

Outcomes

Primary Outcome Measures

Cumulative Probability of Death or Unknown Vital Status by Week 24
The Kaplan-Meier estimate of the cumulative probability of death or unknown vital status by week 24. The vital status was considered unknown at week 24 if a participant prematurely discontinued from the study before week 24 and no vital status was obtained at week 48.

Secondary Outcome Measures

Cumulative Probability of Death by Week 24
The Kaplan-Meier estimate of cumulative probability of death by week 24
Cumulative Probability of First AIDS Progression by Week 96
The Kaplan-Meier estimate of the cumulative probability of first AIDS progression which was defined as the identification of a new World Health Organization (WHO) stage 3 or 4 condition
Cumulative Probability of Death or AIDS Progression by Week 24
The Kaplan-Meier estimate of the cumulative probability of death or AIDS progression by week 24. AIDS progression was defined as new WHO stage 3 or 4 conditions occurred after study entry.
Proportion of Participants With HIV-1 RNA Level <400 Copies/mL
Proportion of participants with HIV-1 RNA level <400 copies/mL.
CD4+ T-cell Count
The absolute levels of CD4+ T-cell counts (cells/mm^3)
CD4+ T-cell Count Change From Baseline
Change was calculated as the CD4+ T-cell count at the later weeks (4, 24 and 48) minus the baseline (week 0) CD4+ T-cell count.
Time to Initiation of TB Treatment by Week 96
Median time to TB treatment initiation since study entry
Proportion of Participants With TB Diagnosis by Week 96
Proportion of participants with TB diagnosis per current ACTG Diagnosis Appendix 60 by week 96
Proportion of Participants With at Least One New Grade 3 or 4 Adverse Event That is at Least a One-grade Increase From Baseline by Week 48
Proportion of participants with at least one new Grade 3 or 4 laboratory or sign or symptom that is at least a one-grade increase from baseline by Week 48. Grade 3=Severe, Grade 4=Life-Threatening according to DAIDS AE Grading Table (see references).
Proportion of Participants With at Least One New Grade 3 or 4 Targeted Laboratory Value That is at Least a One-grade Increase From Baseline by Week 48
Proportion of participants with at least one new Grade 3 or 4 that is at least a one-grade increase from baseline for the following targeted laboratory values by Week 48 The targeted laboratory events include hemoglobin, serum creatinine, ALT and AST
Proportion of Participants With Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48
Proportion of participants with IRIS (using current ACTG definition Appendix 60, see References) by Week 48. IRIS in participants with TB and other opportunistic infections may occur shortly after the initiation of potent combination ART, particularly in participants with advanced HIV disease.
Proportion of Participants With Reportable Hospitalization by Week 48
Proportion of participants with reportable hospitalization reported by Week 48
Proportion of Participants Who Prematurely Discontinued Any Component of TB Treatment by Week 48
Proportion of participants with premature discontinuation of any component of TB treatment by Week 48
Proportion of Participants Who Prematurely Discontinued Antiretroviral Therapy by Week 48
Proportion of participants with premature discontinuation of antiretroviral therapy (ART) by Week 48
Cumulative Probability of Death or AIDS Progression by Week 48
The Kaplan-Meier estimate of the cumulative probability of death or AIDS progression by week 48. AIDS progression was defined as new WHO stage 3 or 4 conditions occurred after study entry.

Full Information

First Posted
June 22, 2011
Last Updated
January 8, 2021
Sponsor
AIDS Clinical Trials Group
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT01380080
Brief Title
REMEMBER: Reducing Early Mortality & Morbidity by Empiric Tuberculosis (TB) Treatment
Acronym
REMEMBER
Official Title
Reducing Early Mortality and Early Morbidity by Empiric Tuberculosis Treatment Regimens (REMEMBER)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 2011 (Actual)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AIDS Clinical Trials Group
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
People with HIV have a high chance of becoming infected with TB, especially when they live in areas where TB infection is common. It can be difficult to diagnose TB in people who need to start HIV treatment right away. Within about 6 months after starting HIV treatment, some of these people can become very sick with TB and can even die from it. This study was being done in people who were starting HIV treatment and who lived in areas where the TB infection rate is high. The purpose of this study was to test an experimental approach to TB treatment to see if it is better than the usual approach. The experimental approach was to start TB treatment at the same time as HIV treatment, even when TB infection had not been found. The usual approach was to start TB treatment only if TB infection was found. In this study, half of the people started TB treatment at the same time as they started their HIV treatment. The other half started TB treatment only if TB infection was found. The study also tested how safe and effective it was to start TB treatment at about the same time as HIV treatment even when TB infection had not been found. The study collected information about diet, whether (and when) people in the study became sicker or died, how well their HIV was controlled, how they were feeling, how they were taking their medications, whether it mattered where they lived or what kind of HIV and TB care was standard, how many people were diagnosed with TB while in the study, and how the cost of the two treatment options on a national level could be compared.
Detailed Description
This was a randomized, open-label, phase IV strategy trial for participants from resource-limited settings (RLS) who presented with advanced HIV disease and no probable or confirmed tuberculosis (TB), and who were initiating antiretroviral treatment (ART). Participants were randomized to one of two strategy arms: immediate, empiric TB treatment (Empiric arm) or local standard of care TB treatment (IPT arm). Randomization was balanced by clinical trial unit and stratified according to CD4+ T cell count (<25 vs. ≥25 cells/mm^3) and presence of any of the following prognostic factors: reportable hospitalization within the past 30 days, BMI <18.5 kg/m^2, or anemia (hemoglobin <8 g/dl). Participants were followed for 96 weeks. Participants attended study visits at screening, enrollment, and weeks 1, 2, 4, 8, 12, 16, 20, 24 and 48. Signs and symptoms, ART modifications, concomitant medications, and clinical events as defined by AIDS Clinical Trials Group (ACTG) Appendix 60 were collected at each visit. Blood was collected for CD4 and HIV-1 RNA at study entry, weeks 4, 24 and 48, and blood for safety laboratories (liver function, hematology, and renal function) was collected at all visits except week 1. A sputum sample was collected and stored at study entry. Phone contact was conducted at weeks 60, 72, 84 and 96 to obtain information about vital status, reportable hospitalization, TB status (including screening and follow-up), TB and HIV treatment modifications, and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
851 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Empiric
Arm Type
Experimental
Arm Description
Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
Arm Title
Arm B: IPT
Arm Type
Experimental
Arm Description
Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
Intervention Type
Drug
Intervention Name(s)
Atripla (r)
Intervention Description
Patients are administered one tablet of Efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (EFV/FTC/TDF, Atripla) to taken be taken orally once daily at bedtime without food.
Intervention Type
Drug
Intervention Name(s)
Efavirenz
Other Intervention Name(s)
EFV
Intervention Description
Participants will take one 600 mg tablet administered orally once daily without food.
Intervention Type
Drug
Intervention Name(s)
Truvada
Intervention Description
Participants will take one tablet of Emtricitabine 200mg/tenofovir disoproxil fumarate 300mg (FTC/TDF, Truvada) administered orally once daily with or without food.
Intervention Type
Drug
Intervention Name(s)
Rifampin/isoniazid/pyrazinamide/ethambutol FDC
Intervention Description
Participants will be administered Rifampin/isoniazid/pyrazinamide/ethambutol FDC tablets orally, once daily; dose by weight as determined in Table 5.1-1 of the protocol, for the first 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Rifampin/isoniazid FDC
Intervention Description
Participants will be administered rifampin/isoniazid FDC tablets orally, once daily; dose by weight as determined in Table 5.1-1 in the protocol, for 16 weeks following the first 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Isoniazid
Intervention Description
INH 300 mg orally once daily
Primary Outcome Measure Information:
Title
Cumulative Probability of Death or Unknown Vital Status by Week 24
Description
The Kaplan-Meier estimate of the cumulative probability of death or unknown vital status by week 24. The vital status was considered unknown at week 24 if a participant prematurely discontinued from the study before week 24 and no vital status was obtained at week 48.
Time Frame
From study entry to week 24
Secondary Outcome Measure Information:
Title
Cumulative Probability of Death by Week 24
Description
The Kaplan-Meier estimate of cumulative probability of death by week 24
Time Frame
From study entry to week 24
Title
Cumulative Probability of First AIDS Progression by Week 96
Description
The Kaplan-Meier estimate of the cumulative probability of first AIDS progression which was defined as the identification of a new World Health Organization (WHO) stage 3 or 4 condition
Time Frame
From study entry to week 96
Title
Cumulative Probability of Death or AIDS Progression by Week 24
Description
The Kaplan-Meier estimate of the cumulative probability of death or AIDS progression by week 24. AIDS progression was defined as new WHO stage 3 or 4 conditions occurred after study entry.
Time Frame
From study entry to week 24
Title
Proportion of Participants With HIV-1 RNA Level <400 Copies/mL
Description
Proportion of participants with HIV-1 RNA level <400 copies/mL.
Time Frame
At weeks 0, 4, 24, and 48
Title
CD4+ T-cell Count
Description
The absolute levels of CD4+ T-cell counts (cells/mm^3)
Time Frame
At weeks 0, 4, 24, and 48
Title
CD4+ T-cell Count Change From Baseline
Description
Change was calculated as the CD4+ T-cell count at the later weeks (4, 24 and 48) minus the baseline (week 0) CD4+ T-cell count.
Time Frame
Weeks 0, 4, 24 and 48
Title
Time to Initiation of TB Treatment by Week 96
Description
Median time to TB treatment initiation since study entry
Time Frame
From study entry to week 96
Title
Proportion of Participants With TB Diagnosis by Week 96
Description
Proportion of participants with TB diagnosis per current ACTG Diagnosis Appendix 60 by week 96
Time Frame
From study entry to week 96
Title
Proportion of Participants With at Least One New Grade 3 or 4 Adverse Event That is at Least a One-grade Increase From Baseline by Week 48
Description
Proportion of participants with at least one new Grade 3 or 4 laboratory or sign or symptom that is at least a one-grade increase from baseline by Week 48. Grade 3=Severe, Grade 4=Life-Threatening according to DAIDS AE Grading Table (see references).
Time Frame
From study entry to week 48
Title
Proportion of Participants With at Least One New Grade 3 or 4 Targeted Laboratory Value That is at Least a One-grade Increase From Baseline by Week 48
Description
Proportion of participants with at least one new Grade 3 or 4 that is at least a one-grade increase from baseline for the following targeted laboratory values by Week 48 The targeted laboratory events include hemoglobin, serum creatinine, ALT and AST
Time Frame
From study entry to week 48. The lab events were collected at study entry, weeks 2, 4, 8, 12, 16, 20, 24, and 48.
Title
Proportion of Participants With Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48
Description
Proportion of participants with IRIS (using current ACTG definition Appendix 60, see References) by Week 48. IRIS in participants with TB and other opportunistic infections may occur shortly after the initiation of potent combination ART, particularly in participants with advanced HIV disease.
Time Frame
From study entry to week 48
Title
Proportion of Participants With Reportable Hospitalization by Week 48
Description
Proportion of participants with reportable hospitalization reported by Week 48
Time Frame
From study entry to week 48
Title
Proportion of Participants Who Prematurely Discontinued Any Component of TB Treatment by Week 48
Description
Proportion of participants with premature discontinuation of any component of TB treatment by Week 48
Time Frame
From study entry to week 48
Title
Proportion of Participants Who Prematurely Discontinued Antiretroviral Therapy by Week 48
Description
Proportion of participants with premature discontinuation of antiretroviral therapy (ART) by Week 48
Time Frame
From study entry to week 48
Title
Cumulative Probability of Death or AIDS Progression by Week 48
Description
The Kaplan-Meier estimate of the cumulative probability of death or AIDS progression by week 48. AIDS progression was defined as new WHO stage 3 or 4 conditions occurred after study entry.
Time Frame
From study entry to week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV-1 infection Willingness to start efavirenz-based ART as soon as possible and within no more than 3 days following randomization. CD4+ cell count <50 cells/mm^3 obtained within 45 days prior to study entry Aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), and total bilirubin ≤ 2.5 X ULN within 30 days prior to study entry. Creatinine clearance ≥30 mL/min either measured or estimated using values obtained within 30 days prior to study entry. Results from a hepatitis B surface antigen test performed within 30 days prior to study entry. Agreement not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization). Female candidates of reproductive potential must have a negative serum or urine (15-25 mIU/mL) pregnancy test result within 7 days prior to study entry. Female candidates of reproductive potential who are participating in sexual activity that could lead to pregnancy must use two reliable methods of contraception while on study. Karnofsky performance score >/= 30 at time of study entry. Ability to swallow medications. Ability and willingness of participant or legal guardian/representative to provide informed consent. Intention to remain in the same general geographic region for the duration of study participation. Exclusion Criteria: Presence of any confirmed or probable TB based on criteria listed in the current ACTG diagnosis appendix within 30 days prior to study entry and following completion of study-specific screening algorithm. Use of single-dose NVP for prevention of mother-to-child transmission (pMTCT) within 24 months prior to study entry. Use of prohibited medications within 30 days prior to study entry. Known allergy/sensitivity or any hypersensitivity to components of study-required ART or TB treatment. Current receipt of treatment for active TB or receipt of >14 days cumulative treatment for active TB within 96 weeks prior to study entry. Receipt of >30 days cumulative of INH prophylaxis within 48 weeks prior to study entry. Receipt at any time prior to study entry of >7 days cumulative treatment with any ARV or combination of ARVs (except for ARVs taken for any length of time during pregnancy for pMTCT, or ARVs taken for occupational exposure). Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. Current Grade ≥2 neuropathy. History of multi-drug-resistant (MDR) TB. Within 12 weeks prior to entry, exposure to a household member or co-worker with known MDR TB.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mina C Hosseinipour, MD
Organizational Affiliation
University of North Carolina Lilongwe CRS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Johnstone Kumwenda, MBChB, FRCP
Organizational Affiliation
College of Med. JHU CRS
Official's Role
Study Chair
Facility Information:
Facility Name
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
City
Rio de Janeiro,
ZIP/Postal Code
21045-900
Country
Brazil
Facility Name
GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS
City
Port Au Prince
Country
Haiti
Facility Name
Les Centres GHESKIO CRS
City
Port-au-Prince
ZIP/Postal Code
6110
Country
Haiti
Facility Name
YRG CARE Medical Ctr., VHS Chennai CRS
City
Rajiv Gandhi Salai Taramani
State/Province
Chennai
ZIP/Postal Code
600113
Country
India
Facility Name
BJ Medical College CRS
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
AMPATH at Moi Univ. Teaching Hosp. Eldoret CRS
City
Eldoret
ZIP/Postal Code
30100
Country
Kenya
Facility Name
Walter Reed Project - Kenya Med. Research Institute Kericho CRS
City
Kericho
ZIP/Postal Code
20200
Country
Kenya
Facility Name
College of Med. JHU CRS (30301)
City
Blantyre
Country
Malawi
Facility Name
University of North Carolina Lilongwe CRS (12001)
City
Lilongwe
Country
Malawi
Facility Name
San Miguel CRS
City
San Miguel
State/Province
Lima
Country
Peru
Facility Name
Barranco CRS (11301)
City
Lima
ZIP/Postal Code
18 PE
Country
Peru
Facility Name
Wits HIV CRS
City
Johannesburg
State/Province
Gauteng
Country
South Africa
Facility Name
CAPRISA eThekwini CRS
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4011
Country
South Africa
Facility Name
Durban Adult HIV CRS
City
Durban
State/Province
KwaZulu-Natal
Country
South Africa
Facility Name
Soweto ACTG CRS (12301)
City
Johannesburg
Country
South Africa
Facility Name
Joint Clinical Research Centre (JCRC) (12401)
City
Kampala
Country
Uganda
Facility Name
Kalingalinga Clinic CRS (12801)
City
Lusaka
Country
Zambia
Facility Name
UZ-Parirenyatwa CRS
City
AIDS Research Unit P.O. Box A178
State/Province
Harare
Country
Zimbabwe

12. IPD Sharing Statement

Citations:
Citation
M. Hosseinipour, G. Bisson, S., et al. Empiric TB therapy does not decrease early mortality compared to Isoniazid Preventive therapy in adults with advanced HIV initiating ART: Results of ACTG A5274 (REMEMBER study). Program and abstracts of the 8th IAS Conference on HIV Pathogenesis, Treatment and prevention; July 19-22, 2015; Vancouver, Canada. Abstract A-729-0105-03495
Results Reference
background
Citation
Johnstone Kumwenda, Amita Gupta, et al. Empiric TB therapy versus IPT in HIV-infected persons initiating ART (ACTG A5274 48 week results). Program and abstracts of the 2016 Conference on Retroviruses and Opportunistic Infections; February 22-25, 2016; Boston, Massachusetts. Abstract 16-1383
Results Reference
background
Citation
Gregory P. Bisson, Amita Gupta, et al. Urine LAM Testing in Advanced HIV-Infected Adults in a Trial of Empiric TB Therapy. Program and abstracts of the 2016 Conference on Retroviruses and Opportunistic Infections; February 22-25, 2016; Boston, Massachusetts. Abstract 16-1650
Results Reference
background
PubMed Identifier
31761933
Citation
Manabe YC, Andrade BB, Gupte N, Leong S, Kintali M, Matoga M, Riviere C, Samaneka W, Lama JR, Naidoo K, Zhao Y, Johnson WE, Ellner JJ, Hosseinipour MC, Bisson GP, Salgame P, Gupta A. A Parsimonious Host Inflammatory Biomarker Signature Predicts Incident Tuberculosis and Mortality in Advanced Human Immunodeficiency Virus. Clin Infect Dis. 2020 Dec 17;71(10):2645-2654. doi: 10.1093/cid/ciz1147.
Results Reference
derived
PubMed Identifier
27025337
Citation
Hosseinipour MC, Bisson GP, Miyahara S, Sun X, Moses A, Riviere C, Kirui FK, Badal-Faesen S, Lagat D, Nyirenda M, Naidoo K, Hakim J, Mugyenyi P, Henostroza G, Leger PD, Lama JR, Mohapi L, Alave J, Mave V, Veloso VG, Pillay S, Kumarasamy N, Bao J, Hogg E, Jones L, Zolopa A, Kumwenda J, Gupta A; Adult AIDS Clinical Trials Group A5274 (REMEMBER) Study Team. Empirical tuberculosis therapy versus isoniazid in adult outpatients with advanced HIV initiating antiretroviral therapy (REMEMBER): a multicountry open-label randomised controlled trial. Lancet. 2016 Mar 19;387(10024):1198-209. doi: 10.1016/S0140-6736(16)00546-8.
Results Reference
derived
Links:
URL
http://rsc.tech-res.com/safetyandpharmacovigilance/
Description
The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009)
URL
http://rsc.tech-res.com/clinical-research-sites/safety-reporting/manual
Description
Manual for Expedited Reporting of Adverse Events to DAID, Version 2.0, January 2010

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REMEMBER: Reducing Early Mortality & Morbidity by Empiric Tuberculosis (TB) Treatment

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