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Immediate Versus Deferred Start of Anti-HIV Therapy in HIV-Infected Adults Being Treated for Tuberculosis (STRIDE)

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ClinicalTrials.gov Identifier: NCT00108862
Recruitment Status : Completed
First Posted : April 20, 2005
Results First Posted : November 2, 2011
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV Infection
Tuberculosis
Interventions Other: Strategy: Immediate ART
Other: Strategy: Deferred ART
Enrollment 809
Recruitment Details Study participants were recruited at 26 sites from 13 countries: 4 each from U.S. and South Africa; 3 from Brazil; 2 each from Peru, Botswana, Kenya, Malawi, and India; and 1 each from Haiti, Uganda, Zambia, Zimbabwe, and Thailand, between September 2006 and August 2009.
Pre-assignment Details HIV-infected persons at least 13 years of age, naive to antiretroviral therapy, who had received 1-14 cumulative days of a rifamycin-based TB regimen within 28 days prior to study entry, and had a CD4 count <250 cells/mm3. Randomization was stratified by screening CD4 (<50 vs =>50). Three participants were deemed ineligible and taken off study.
Arm/Group Title Immediate ART Deferred ART
Hide Arm/Group Description These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator. These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
Period Title: Overall Study
Started 405 401 [1]
Completed 337 339
Not Completed 68 62
Reason Not Completed
Death             31             37
Withdrawal by Subject             10             6
Lost to Follow-up             27             19
[1]
Three participants who were deemed clinically ineligible and taken off study were omitted.
Arm/Group Title Immediate ART Deferred ART Total
Hide Arm/Group Description These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator. These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator. Total of all reporting groups
Overall Number of Baseline Participants 405 401 806
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 405 participants 401 participants 806 participants
<=18 years
0
   0.0%
2
   0.5%
2
   0.2%
Between 18 and 65 years
403
  99.5%
398
  99.3%
801
  99.4%
>=65 years
2
   0.5%
1
   0.2%
3
   0.4%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 405 participants 401 participants 806 participants
34
(29 to 40)
34
(29 to 42)
34
(29 to 41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 405 participants 401 participants 806 participants
Female
139
  34.3%
166
  41.4%
305
  37.8%
Male
266
  65.7%
235
  58.6%
501
  62.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 405 participants 401 participants 806 participants
South Africa 109 112 221
Malawi 69 68 137
Brazil 57 56 113
Kenya 36 36 72
Peru 23 25 48
India 26 21 47
Zambia 17 17 34
Zimbabwe 16 17 33
Uganda 15 14 29
Botswana 13 15 28
Haiti 12 8 20
United States 9 10 19
Thailand 3 2 5
TB Diagnosis Level at Entry  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 405 participants 401 participants 806 participants
Confirmed TB 193 181 374
Probable TB 208 218 426
Not TB 4 2 6
Drug-Resistant TB Status at Entry  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 405 participants 401 participants 806 participants
Rifampin (RIF) Resistant TB 1 0 1
Isoniazid (INH) Resistant TB 3 5 8
RIF and INH Resistant TB (Multi-Drug Resistant TB) 1 4 5
RIF and INH Sensitive TB 400 392 792
Time to ART Start from Start of TB Medications  
Median (Inter-Quartile Range)
Unit of measure:  Days
Number Analyzed 405 participants 401 participants 806 participants
10
(7 to 12)
70
(66 to 75)
14
(10 to 70)
1.Primary Outcome
Title Percent of Participants Who Survived Without AIDS Progression.
Hide Description As this was a study of the strategy of providing antiretroviral therapy (ART) during the initial treatment of TB versus deferring ART until TB was treated for 8-12 weeks, all eligible participants randomized were followed for 48 weeks, whether they started ART as scheduled, whether they started ART at all, or even if the participant did not have TB and discontinued TB treatment. The percent surviving without a new AIDS-defining illness was calculated using a Kaplan-Meier estimator with an associated standard error.
Time Frame Through week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).
Arm/Group Title Immediate ART Deferred ART
Hide Arm/Group Description:
These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
Overall Number of Participants Analyzed 405 401
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
13
(10 to 16)
16
(12 to 20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immediate ART, Deferred ART
Comments Assuming that immediate ART was better than deferred ART and that the combined rate in the deferred ART arm was 25% compared to 15% in the immediate ART arm (a 40% reduction), and assuming 10% loss to follow-up in a two-sided, two-sample 0.05-level asymptotically-normal test with 400 participants in each arm, there was 90% power. The percents tested were Kaplan-Meier estimators at week 48 with the associated Greenwood's variance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments The analysis was stratified by screening CD4 (<50 cells/mm3 vs =>50). Interim reviews employed group sequential monitoring using an O'Brien-Fleming use function. At final analysis, the a priori threshold for statistical significance was 0.0492.
Method Z-test, 2-sided
Comments A 2-sided Z-test was used to compare the two percents. The test was weighted by the inverse of the Greenwood's variance in each CD4 stratum.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3
Confidence Interval (2-Sided) 95.08%
-2 to 8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3
Estimation Comments The difference in percents was calculated as the percent failed in the Deferred ART arm minus the percent failed in the Immediate ART arm.
2.Secondary Outcome
Title Percent of Participants Reporting a Grade 3 or 4 Adverse Event or Laboratory Abnormality
Hide Description All eligible participants were included in this analysis. The percent of participants whose highest reported grade of adverse events and laboratory abnormalities was Grade 3 or 4 was calculated with an associated standard error, where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening/disabling, and Grade 5=death.
Time Frame Through week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).
Arm/Group Title Immediate ART Deferred ART
Hide Arm/Group Description:
These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
Overall Number of Participants Analyzed 405 401
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
44
(39 to 49)
47
(42 to 52)
3.Secondary Outcome
Title Time to First New AIDS-defining Illness or Death.
Hide Description All eligible participants were included in this analysis. Weeks from randomization to first new AIDS-defining illness or death was analyzed using a stratified Cox proportional hazards regression model. The stratification was by screening CD4 cell count: <50 cells/mm3 versus =>50 cells/mm3.
Time Frame Through week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).
Arm/Group Title Immediate ART Deferred ART
Hide Arm/Group Description:
These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
Overall Number of Participants Analyzed 405 401
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
5th percentile
4
(3 to 8)
7
(4 to 10)
10th percentile
13
(8 to 49)
12
(9 to 19)
4.Secondary Outcome
Title Percent of Participants With Culture-confirmed Tuberculosis (TB) Who Survived Without AIDS Progression.
Hide Description This analysis was based on 374 participants with culture-confirmed TB at entry. The percent with culture-confirmed TB surviving without a new AIDS-defining illness was calculated using a Kaplan-Meier estimator with an associated standard error.
Time Frame Through week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).
Arm/Group Title Immediate ART Deferred ART
Hide Arm/Group Description:
These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
Overall Number of Participants Analyzed 193 181
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
12
(7 to 17)
17
(12 to 23)
5.Secondary Outcome
Title Percent of Participants Who Interrupted or Discontinued at Least One Tuberculosis (TB) Medication Due to Toxicity.
Hide Description All eligible participants were included in this analysis. The percent of participants who interrupted at least one TB medication for more than one day due to toxicity or discontinued at least one TB medication due to toxicity was calculated with an associated standard error.
Time Frame Through week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immediate ART Deferred ART
Hide Arm/Group Description:
These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
Overall Number of Participants Analyzed 405 401
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
9
(6 to 12)
10
(7 to 13)
6.Secondary Outcome
Title Percent of Participants With Confirmed or Probable Tuberculosis (TB) Whose TB Resolved, or Who Required TB Treatment Through the End of Follow-up, or Died, or Were Lost to Follow-up.
Hide Description TB treatment outcome was assessed in the 800 eligible participants who had confirmed or probable TB at study entry. The sites determined if the TB was resolved. If TB was not resolved, TB treatment outcome status was determined based on whether TB treatment was ongoing at the last study visit; if the participant died while TB treatment was ongoing; or if the participant was lost to follow-up, withdrew consent, or other reason for lacking TB resolution status. Percents were calculated with associated standard errors.
Time Frame Through week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with confirmed or probable TB at study entry were included in this analysis. Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).
Arm/Group Title Immediate ART Deferred ART
Hide Arm/Group Description:
These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
Overall Number of Participants Analyzed 401 399
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
TB Resolved
79
(75 to 83)
82
(78 to 85)
TB Treatment Ongoing
6
(4 to 9)
5
(3 to 8)
Death
6
(4 to 9)
7
(5 to 10)
Lost-to-Follow-up/Withdrew Consent/Other
8
(5 to 11)
6
(4 to 9)
7.Secondary Outcome
Title Percent of Participants Whose CD4 Increased by at Least 100 Cells/mm^3 Between Baseline and Week 48.
Hide Description All eligible participants were included in the analysis. Participants who were lost-to-follow-up (LFU) prior to week 48 or who were alive with a CD4 cell count increase of less than 100 cells/mm^3 were grouped separately those who died or whose CD4 cell count increased by at least 100 cells/mm^3. Participants missing CD4 cell counts at week 48 were coded as LFU in this analysis. The percents were calculated with associated standard errors.
Time Frame Through week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).
Arm/Group Title Immediate ART Deferred ART
Hide Arm/Group Description:
These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
Overall Number of Participants Analyzed 405 401
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
CD4 increase of at least 100 cells/mm^3
60
(55 to 65)
60
(55 to 65)
LFU, or alive with CD4 increase < 100 cells/mm^3
32
(28 to 37)
31
(26 to 35)
Dead
8
(5 to 11)
9
(7 to 13)
8.Secondary Outcome
Title Percent of Participants With MTB IRIS.
Hide Description All eligible participants were included in this analysis. The percent of participants with Mycobacteria tuberculosis (MTB)-associated immune reconstitution inflammatory syndrome (IRIS) was calculated with an associated standard error.
Time Frame Through week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).
Arm/Group Title Immediate ART Deferred ART
Hide Arm/Group Description:
These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
Overall Number of Participants Analyzed 405 401
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
11
(8 to 14)
5
(3 to 7)
9.Secondary Outcome
Title Percent of Participants With HIV IRIS.
Hide Description All eligible participants were included in this analysis. The percent of participants with HIV-associated immune reconstitution inflammatory syndrome (IRIS) was calculated with an associated standard error.
Time Frame Through week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).
Arm/Group Title Immediate ART Deferred ART
Hide Arm/Group Description:
These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
Overall Number of Participants Analyzed 405 401
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
3
(2 to 5)
3
(1 to 5)
10.Secondary Outcome
Title Percent of Participants Whose HIV Viral Load Was Less Than 400 Copies/mL at Week 48.
Hide Description All eligible participants were included in the analysis. Participants who were lost-to-follow-up (LFU) prior to week 48 or who were alive with a HIV viral load at least 400 copies/mL were grouped separately those those who died or who had HIV viral loads below 400 copies/mL. Participants missing HIV viral loads at week 48 were coded as LFU in this analysis. Percents were calculated with associated standard errors.
Time Frame Through week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).
Arm/Group Title Immediate ART Deferred ART
Hide Arm/Group Description:
These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
Overall Number of Participants Analyzed 405 401
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
HIV viral load < 400 copies/mL
72
(68 to 77)
75
(71 to 79)
LFU, or alive with HIV viral load at least 400
20
(16 to 24)
16
(12 to 20)
Dead
8
(5 to 11)
9
(7 to 13)
11.Other Pre-specified Outcome
Title Percent of Participants in the Less Than 50 Cells/mm^3 CD4 Stratum Who Survived Without AIDS Progression.
Hide Description Participants were included as described in the Outcome Measure Description for the Primary Outcome, except that only those in the <50 CD4 stratum were analyzed. The percent surviving without a new AIDS-defining illness was calculated using a Kaplan-Meier estimator with an associated standard error.
Time Frame Through week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).
Arm/Group Title Immediate ART Deferred ART
Hide Arm/Group Description:
These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
Overall Number of Participants Analyzed 144 141
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
16
(10 to 21)
27
(19 to 39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immediate ART, Deferred ART
Comments The study was not powered for this pre-specified subgroup analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments Interim reviews employed group sequential monitoring using an > O'Brien-Fleming use function. At final analysis, the a priori threshold for statistical significance was 0.0492.
Method Z-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11
Confidence Interval (2-Sided) 95.08%
2 to 21
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5
Estimation Comments The difference in percents was calculated as the percent failed in the Deferred ART arm minus the percent failed in the Immediate ART arm.
12.Other Pre-specified Outcome
Title Percent of Participants in the Greater Than or Equal to 50 Cells/mm^3 CD4 Stratum Who Survived Without AIDS Progression.
Hide Description Participants were included as described in the Outcome Measure Description for the Primary Outcome, except that only those in the =>50 CD4 stratum were analyzed. The percent surviving without a new AIDS-defining illness was calculated using a Kaplan-Meier estimator with an associated standard error.
Time Frame Through week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).
Arm/Group Title Immediate ART Deferred ART
Hide Arm/Group Description:
These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
Overall Number of Participants Analyzed 261 260
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
11
(8 to 15)
10
(7 to 14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immediate ART, Deferred ART
Comments The study was not powered for this pre-specified subgroup analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments Interim reviews employed group sequential monitoring using an O'Brien-Fleming use function. At final analysis, the a priori threshold for statistical significance was 0.0492.
Method Z-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1
Confidence Interval (2-Sided) 95.08%
-7 to 4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3
Estimation Comments The difference in percents was calculated as the percent failed in the Deferred ART arm minus the percent failed in the Immediate ART arm.
Time Frame Through week 48
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Immediate ART Deferred ART
Hide Arm/Group Description These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator. These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
All-Cause Mortality
Immediate ART Deferred ART
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Immediate ART Deferred ART
Affected / at Risk (%) Affected / at Risk (%)
Total   55/405 (13.58%)   44/401 (10.97%) 
Blood and lymphatic system disorders     
Anaemia  1  6/405 (1.48%)  1/401 (0.25%) 
Leukopenia  1  1/405 (0.25%)  0/401 (0.00%) 
Neutropenia  1  1/405 (0.25%)  3/401 (0.75%) 
Cardiac disorders     
Cardiac failure congestive  1  1/405 (0.25%)  1/401 (0.25%) 
Gastrointestinal disorders     
Ascites  1  1/405 (0.25%)  0/401 (0.00%) 
Diarrhoea  1  2/405 (0.49%)  0/401 (0.00%) 
Oesophagitis  1  0/405 (0.00%)  1/401 (0.25%) 
Peritonitis  1  0/405 (0.00%)  1/401 (0.25%) 
Vomiting  1  1/405 (0.25%)  0/401 (0.00%) 
General disorders     
Death  1  2/405 (0.49%)  6/401 (1.50%) 
Pyrexia  1  1/405 (0.25%)  0/401 (0.00%) 
Hepatobiliary disorders     
Hepatitis  1  1/405 (0.25%)  2/401 (0.50%) 
Hepatitis alcoholic  1  1/405 (0.25%)  0/401 (0.00%) 
Hepatotoxicity  1  5/405 (1.23%)  4/401 (1.00%) 
Hyperbilirubinaemia  1  1/405 (0.25%)  1/401 (0.25%) 
Infections and infestations     
Bacterial sepsis  1  1/405 (0.25%)  0/401 (0.00%) 
Gastroenteritis  1  0/405 (0.00%)  2/401 (0.50%) 
Meningitis bacterial  1  1/405 (0.25%)  0/401 (0.00%) 
Meningitis cryptococcal  1  0/405 (0.00%)  3/401 (0.75%) 
Meningitis tuberculous  1  2/405 (0.49%)  1/401 (0.25%) 
Mycobacterium avium complex infection  1  2/405 (0.49%)  1/401 (0.25%) 
Pneumocystis jiroveci pneumonia  1  1/405 (0.25%)  0/401 (0.00%) 
Pneumonia bacterial  1  1/405 (0.25%)  1/401 (0.25%) 
Pulmonary tuberculosis  1  7/405 (1.73%)  1/401 (0.25%) 
Sepsis  1  0/405 (0.00%)  3/401 (0.75%) 
Tuberculoma of central nervous system  1  1/405 (0.25%)  0/401 (0.00%) 
Tuberculosis  1  1/405 (0.25%)  0/401 (0.00%) 
Viral myocarditis  1  1/405 (0.25%)  0/401 (0.00%) 
Injury, poisoning and procedural complications     
Alcohol poisoning  1  1/405 (0.25%)  0/401 (0.00%) 
Gun shot wound  1  1/405 (0.25%)  1/401 (0.25%) 
Investigations     
Aspartate aminotransferase increased  1  1/405 (0.25%)  0/401 (0.00%) 
Blood alkaline phosphatase increased  1  0/405 (0.00%)  1/401 (0.25%) 
Blood creatinine increased  1  1/405 (0.25%)  1/401 (0.25%) 
Neutrophil count decreased  1  0/405 (0.00%)  4/401 (1.00%) 
Metabolism and nutrition disorders     
Hypokalaemia  1  1/405 (0.25%)  0/401 (0.00%) 
Hyponatraemia  1  2/405 (0.49%)  0/401 (0.00%) 
Hypophosphataemia  1  1/405 (0.25%)  3/401 (0.75%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Meningioma  1  1/405 (0.25%)  0/401 (0.00%) 
Nervous system disorders     
Central nervous system mass  1  0/405 (0.00%)  1/401 (0.25%) 
Cerebral haemorrhage  1  1/405 (0.25%)  0/401 (0.00%) 
Coma hepatic  1  1/405 (0.25%)  0/401 (0.00%) 
Encephalitis  1  1/405 (0.25%)  0/401 (0.00%) 
Hemiplegia  1  1/405 (0.25%)  0/401 (0.00%) 
Intracranial pressure increased  1  1/405 (0.25%)  0/401 (0.00%) 
Psychiatric disorders     
Completed suicide  1  0/405 (0.00%)  1/401 (0.25%) 
Confusional state  1  1/405 (0.25%)  0/401 (0.00%) 
Renal and urinary disorders     
Renal failure  1  3/405 (0.74%)  0/401 (0.00%) 
Renal failure acute  1  3/405 (0.74%)  2/401 (0.50%) 
Renal impairment  1  2/405 (0.49%)  0/401 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  0/405 (0.00%)  1/401 (0.25%) 
Epistaxis  1  0/405 (0.00%)  1/401 (0.25%) 
Pulmonary embolism  1  0/405 (0.00%)  1/401 (0.25%) 
Respiratory failure  1  1/405 (0.25%)  0/401 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  1  2/405 (0.49%)  0/401 (0.00%) 
Vascular disorders     
Shock  1  0/405 (0.00%)  1/401 (0.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Immediate ART Deferred ART
Affected / at Risk (%) Affected / at Risk (%)
Total   391/405 (96.54%)   389/401 (97.01%) 
Blood and lymphatic system disorders     
Lymphadenopathy  1  37/405 (9.14%)  19/401 (4.74%) 
Gastrointestinal disorders     
Abdominal pain  1  27/405 (6.67%)  21/401 (5.24%) 
Diarrhoea  1  23/405 (5.68%)  33/401 (8.23%) 
Leukoplakia oral  1  20/405 (4.94%)  30/401 (7.48%) 
Nausea  1  21/405 (5.19%)  18/401 (4.49%) 
Vomiting  1  42/405 (10.37%)  39/401 (9.73%) 
General disorders     
Chest pain  1  26/405 (6.42%)  20/401 (4.99%) 
Pyrexia  1  75/405 (18.52%)  63/401 (15.71%) 
Infections and infestations     
Herpes zoster  1  19/405 (4.69%)  22/401 (5.49%) 
Oral candidiasis  1  47/405 (11.60%)  78/401 (19.45%) 
Pneumonia bacterial  1  29/405 (7.16%)  34/401 (8.48%) 
Investigations     
Alanine aminotransferase increased  1  79/405 (19.51%)  82/401 (20.45%) 
Aspartate aminotransferase increased  1  132/405 (32.59%)  152/401 (37.91%) 
Blood albumin  1  18/405 (4.44%)  21/401 (5.24%) 
Blood albumin abnormal  1  307/405 (75.80%)  323/401 (80.55%) 
Blood alkaline phosphatase increased  1  133/405 (32.84%)  138/401 (34.41%) 
Blood bicarbonate abnormal  1  78/405 (19.26%)  89/401 (22.19%) 
Blood bilirubin increased  1  26/405 (6.42%)  27/401 (6.73%) 
Blood creatinine increased  1  29/405 (7.16%)  28/401 (6.98%) 
Blood phosphorus decreased  1  71/405 (17.53%)  56/401 (13.97%) 
Blood potassium decreased  1  38/405 (9.38%)  33/401 (8.23%) 
Blood sodium decreased  1  212/405 (52.35%)  227/401 (56.61%) 
Haemoglobin decreased  1  211/405 (52.10%)  215/401 (53.62%) 
Neutrophil count decreased  1  86/405 (21.23%)  102/401 (25.44%) 
Platelet count decreased  1  19/405 (4.69%)  34/401 (8.48%) 
Weight decreased  1  21/405 (5.19%)  16/401 (3.99%) 
White blood cell count decreased  1  64/405 (15.80%)  75/401 (18.70%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  27/405 (6.67%)  22/401 (5.49%) 
Nervous system disorders     
Dizziness  1  33/405 (8.15%)  31/401 (7.73%) 
Headache  1  41/405 (10.12%)  53/401 (13.22%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  47/405 (11.60%)  44/401 (10.97%) 
Dyspnoea  1  33/405 (8.15%)  25/401 (6.23%) 
Oropharyngeal plaque  1  21/405 (5.19%)  39/401 (9.73%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  9/405 (2.22%)  24/401 (5.99%) 
Rash  1  35/405 (8.64%)  49/401 (12.22%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
Results Point of Contact
Name/Title: ACTG ClinicalTrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00108862     History of Changes
Other Study ID Numbers: ACTG A5221
1U01AI068636 ( U.S. NIH Grant/Contract )
ACTG A5221 ( Other Identifier: AIDS Clinical Trials Group )
First Submitted: April 19, 2005
First Posted: April 20, 2005
Results First Submitted: September 27, 2011
Results First Posted: November 2, 2011
Last Update Posted: October 11, 2018