Trial · NCT01380080

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

NCT01380080, Phase 4, Completed, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections; results first posted 2016-02-23

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. REMEMBER: Reducing Early Mortality & Morbidity by Empiric Tuberculosis (TB) Treatment. Trials, record NCT01380080. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01380080

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: REMEMBER: Reducing Early Mortality & Morbidity by Empiric Tuberculosis (TB) Treatment
NCT number: NCT01380080
Status: Completed
Phases: Phase 4
Enrollment: 851 participants, actual
Lead sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Conditions: HIV Infection
Interventions: Atripla (r), Efavirenz, Truvada, Rifampin/isoniazid/pyrazinamide/ethambutol FDC, Rifampin/isoniazid FDC, Isoniazid
First posted: 2011-06-27
Last updated: 2024-10-15
Results first posted: 2016-02-23

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Cumulative Probability of Death or Unknown Vital Status by Week 24	From study entry to 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	Cumulative Probability of Death by Week 24	From study entry to week 24	The Kaplan-Meier estimate of cumulative probability of death by week 24
Secondary	Cumulative Probability of First AIDS Progression by Week 96	From study entry to 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
Secondary	Cumulative Probability of Death or AIDS Progression by Week 24	From study entry to 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.
Secondary	Proportion of Participants With HIV-1 RNA Level <400 Copies/mL	At weeks 0, 4, 24, and 48	Proportion of participants with HIV-1 RNA level \<400 copies/mL.
Secondary	CD4+ T-cell Count	At weeks 0, 4, 24, and 48	The absolute levels of CD4+ T-cell counts (cells/mm\^3)
Secondary	CD4+ T-cell Count Change From Baseline	Weeks 0, 4, 24 and 48	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.
Secondary	Time to Initiation of TB Treatment by Week 96	From study entry to week 96	Median time to TB treatment initiation since study entry
Secondary	Proportion of Participants With TB Diagnosis by Week 96	From study entry to week 96	Proportion of participants with TB diagnosis per current ACTG Diagnosis Appendix 60 by week 96
Secondary	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	From study entry to 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).

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Cumulative Probability of Death or Unknown Vital Status by Week 24	From study entry to week 24	Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment	Cumulative probability per 100 persons	NUMBER
SECONDARY	Cumulative Probability of Death by Week 24	From study entry to week 24	Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment	Cumulative probability per 100 persons	NUMBER
SECONDARY	Cumulative Probability of First AIDS Progression by Week 96	From study entry to week 96	Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment	Cumulative probability per 100 persons	NUMBER
SECONDARY	Cumulative Probability of Death or AIDS Progression by Week 24	From study entry to week 24	Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment	Cumulative probability per 100 persons	NUMBER
SECONDARY	Proportion of Participants With HIV-1 RNA Level <400 Copies/mL	At weeks 0, 4, 24, and 48	Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completed at random.	Proportion of participants	NUMBER
SECONDARY	CD4+ T-cell Count	At weeks 0, 4, 24, and 48	Intent to treat: All eligible participants were included in the analysis: Participants were analyzed per original assigned randomized treatment. Missing data were assigned missing completely at random.	cells/ mm^3	MEDIAN
SECONDARY	CD4+ T-cell Count Change From Baseline	Weeks 0, 4, 24 and 48	Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.	cells/ mm^3	MEDIAN
SECONDARY	Time to Initiation of TB Treatment by Week 96	From study entry to week 96	Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment	Days	MEDIAN
SECONDARY	Proportion of Participants With TB Diagnosis by Week 96	From study entry to week 96	Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment	Proportion of participants	NUMBER
SECONDARY	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	From study entry to week 48	Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment	Proportion of participants	NUMBER

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group48

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Cumulative Probability of Death or Unknown Vital Status by Week 24	Arm A: Empiric		5.2	95% Confidence Interval 3.5 to 7.8	Cumulative probability per 100 persons
Cumulative Probability of Death or Unknown Vital Status by Week 24	Arm B: IPT		5.2	95% Confidence Interval 3.4 to 7.8	Cumulative probability per 100 persons
Cumulative Probability of Death by Week 24	Arm A: Empiric		4.8	95% Confidence Interval 3.1 to 7.3	Cumulative probability per 100 persons
Cumulative Probability of Death by Week 24	Arm B: IPT		5.2	95% Confidence Interval 3.4 to 7.8	Cumulative probability per 100 persons
Cumulative Probability of First AIDS Progression by Week 96	Arm A: Empiric		16.6	95% Confidence Interval 13.3 to 20.6	Cumulative probability per 100 persons
Cumulative Probability of First AIDS Progression by Week 96	Arm B: IPT		11.3	95% Confidence Interval 8.6 to 14.8	Cumulative probability per 100 persons
Cumulative Probability of Death or AIDS Progression by Week 24	Arm A: Empiric		17.1	95% Confidence Interval 13.9 to 21.1	Cumulative probability per 100 persons
Cumulative Probability of Death or AIDS Progression by Week 24	Arm B: IPT		12.5	95% Confidence Interval 9.7 to 16.0	Cumulative probability per 100 persons
Proportion of Participants With HIV-1 RNA Level <400 Copies/mL	Arm A: Empiric	Week 0	0	95% Confidence Interval 0 to 0.02	Proportion of participants
Proportion of Participants With HIV-1 RNA Level <400 Copies/mL	Arm B: IPT	Week 0	0.01	95% Confidence Interval 0 to 0.03	Proportion of participants

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A: Empiric	424
Overall Study	STARTED	Arm B: IPT	426
Overall Study	COMPLETED	Arm A: Empiric	339
Overall Study	COMPLETED	Arm B: IPT	343
Overall Study	NOT COMPLETED	Arm A: Empiric	85
Overall Study	NOT COMPLETED	Arm B: IPT	83

Source ClinicalTrials.gov

Adverse events292

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain	Gastrointestinal disorders	Arm A: Empiric	28	424
other	Abdominal pain	Gastrointestinal disorders	Arm B: IPT	26	426
other	Diarrhoea	Gastrointestinal disorders	Arm A: Empiric	42	424
other	Diarrhoea	Gastrointestinal disorders	Arm B: IPT	34	426
other	Nausea	Gastrointestinal disorders	Arm A: Empiric	22	424
other	Nausea	Gastrointestinal disorders	Arm B: IPT	22	426
other	Vomiting	Gastrointestinal disorders	Arm A: Empiric	39	424
other	Vomiting	Gastrointestinal disorders	Arm B: IPT	51	426
other	Pyrexia	General disorders	Arm A: Empiric	46	424
other	Pyrexia	General disorders	Arm B: IPT	55	426

1 to 10 of 292Source ClinicalTrials.gov

See all 292 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A: Empiric	36	424
Total, all-cause mortality	Arm B: IPT	44	426
Total, other adverse events	Arm A: Empiric	380	424
Total, other adverse events	Arm B: IPT	379	426
Total, serious adverse events	Arm A: Empiric	85	424
Total, serious adverse events	Arm B: IPT	94	426

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27025337	DERIVED	PubMed
31761933	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01AI068636	AIDS Clinical Trials Group Network	KURITZKES, DANIEL R.	SOCIAL AND SCIENTIFIC SYSTEMS, INC.	NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES	2006 to 2010

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm A: Empiric vs Arm B: IPT: deaths from any cause	Trial comparisons
Arm A: Empiric vs Arm B: IPT: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01380080

GET https://conductscience.org/api/trials/v1/NCT01380080/results?page=2

API reference For AI assistants