Trial Outcomes & Findings for Safety and Efficacy of Reduced Versus Standard Dose Efavirenz (EFV) Plus Two Nucleotides in Antiretroviral-naïve Adults. (NCT NCT01011413)

Last Updated: 2020-02-21

Results Overview

Percentage of participants in each of the treatment arms with centrally quantified plasma HIV-1 RNA viral load \<200 copies/mL 48 weeks after randomisation.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

636 participants

Primary outcome timeframe

48 weeks

Results posted on

2020-02-21

Participant Flow

38 clinical centres (primary and tertiary care facilities) in 13 countries on 5 continents screened a total of 768 patents who had provided informed consent between Aug 4, 2011 and March 19, 2012.

768 screened:132 did not satisfy eligibility: 2 prior AIDS-defining illness; 3 previous antiretroviral therapy; 15 HIV RNA out of range; 44 cluster of differentiation (CD)4 count out of range; 13 lab values out of range; 2 pregnant; 9 intercurrent illness; 2 illicit substance use; 30 exceeded screen time; 4 clinician exclusion; 9 withdrew consent.

Participant milestones

Participant milestones
Measure	600mg Efavirenz Eligible patients will be centrally randomised to receive tenofovir (TDF) (300mg qd)/emtricitabine (FTC) (200mg qd) + EFV (600mg qd; 3 x 200mg qd) Efavirenz: 3 x EFV 200mg tablets once daily	400mg Efavirenz Eligible patients will be centrally randomised to receive TDF (300mg qd)/FTC (200mg qd) + EFV (400mg qd; 2 x 200mg + 1 x 200mg placebo qd). Efavirenz: 2 x EFV 200mg tablets plus 1x matched EFV placebo tablet once daily
Overall Study STARTED	312	324
Overall Study Did Not Start Study Drug	3	3
Overall Study In Modified ITT	309	321
Overall Study Died Before Week 48	3	2
Overall Study Lost to Follow up Before w48	3	4
Overall Study Withdrew Consent Before w48	3	3
Overall Study Attended w48 Visit	295	311
Overall Study Died Between Week 48 and 96	2	3
Overall Study Withdrew Consent Between Week 48 and 96	2	6
Overall Study Lost to Follow-up Between Week 48 and 96	10	4
Overall Study COMPLETED	286	299
Overall Study NOT COMPLETED	26	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Reduced Versus Standard Dose Efavirenz (EFV) Plus Two Nucleotides in Antiretroviral-naïve Adults.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	600mg Efavirenz n=309 Participants Eligible patients will be centrally randomised to receive tenofovir (TDF) (300mg qd)/emtricitabine (FTC) (200mg qd) + EFV (600mg qd; 3 x 200mg qd) Efavirenz: 3 x EFV 200mg tablets once daily	400mg Efavirenz n=321 Participants Eligible patients will be centrally randomised to receive TDF (300mg qd)/FTC (200mg qd) + EFV (400mg qd; 2 x 200mg + 1 x 200mg placebo qd). Efavirenz: 2 x EFV 200mg tablets plus 1x matched EFV placebo tablet once daily	Total n=630 Participants Total of all reporting groups
Age, Continuous	35.8 years STANDARD_DEVIATION 10.0 • n=5 Participants	36.1 years STANDARD_DEVIATION 10.0 • n=7 Participants	36.0 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	103 Participants n=5 Participants	100 Participants n=7 Participants	203 Participants n=5 Participants
Sex: Female, Male Male	206 Participants n=5 Participants	221 Participants n=7 Participants	427 Participants n=5 Participants
Race/Ethnicity, Customized African	116 participants n=5 Participants	118 participants n=7 Participants	234 participants n=5 Participants
Race/Ethnicity, Customized Asian	103 participants n=5 Participants	106 participants n=7 Participants	209 participants n=5 Participants
Race/Ethnicity, Customized White	90 participants n=5 Participants	97 participants n=7 Participants	187 participants n=5 Participants
HIV transmission risk heterosexual	156 participants n=5 Participants	156 participants n=7 Participants	312 participants n=5 Participants
HIV transmission risk homo/bisexual	134 participants n=5 Participants	138 participants n=7 Participants	272 participants n=5 Participants
HIV transmission risk injecting drug user/not known	19 participants n=5 Participants	27 participants n=7 Participants	46 participants n=5 Participants
CDC HIV infection clinical category category A	265 participants n=5 Participants	264 participants n=7 Participants	529 participants n=5 Participants
CDC HIV infection clinical category category B	33 participants n=5 Participants	46 participants n=7 Participants	79 participants n=5 Participants
CDC HIV infection clinical category category C	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants
Median plasma HIV RNA	4.73 log10 copies per mL n=5 Participants	4.76 log10 copies per mL n=7 Participants	4.75 log10 copies per mL n=5 Participants
Mean nadir cluster of differentiation (CD)4+ cell count	252 cells per mm3 STANDARD_DEVIATION 90 • n=5 Participants	248 cells per mm3 STANDARD_DEVIATION 88 • n=7 Participants	250 cells per mm3 STANDARD_DEVIATION 89 • n=5 Participants
Hep B Sag +ve	12 participants n=5 Participants	15 participants n=7 Participants	27 participants n=5 Participants
Hep C ab +ve	3 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants
Mean creatinine clearance (mL/min)	120 mL per min STANDARD_DEVIATION 32.4 • n=5 Participants	117.4 mL per min STANDARD_DEVIATION 29.7 • n=7 Participants	118.7 mL per min STANDARD_DEVIATION 31.0 • n=5 Participants
Mean total chol (mmol/L)	4.15 mmol per Litre STANDARD_DEVIATION 0.93 • n=5 Participants	4.24 mmol per Litre STANDARD_DEVIATION 0.95 • n=7 Participants	4.20 mmol per Litre STANDARD_DEVIATION 0.94 • n=5 Participants
Mean HDL chol (mmol/L)	1.03 mmol per Litre STANDARD_DEVIATION 0.31 • n=5 Participants	1.04 mmol per Litre STANDARD_DEVIATION 0.32 • n=7 Participants	1.03 mmol per Litre STANDARD_DEVIATION 0.32 • n=5 Participants
Mean LDL chol (mmol/L)	2.47 mmol per Litre STANDARD_DEVIATION 0.84 • n=5 Participants	2.54 mmol per Litre STANDARD_DEVIATION 0.93 • n=7 Participants	2.51 mmol per Litre STANDARD_DEVIATION 0.88 • n=5 Participants
Mean triglycerides (mmol/L)	1.24 mmol per Litre STANDARD_DEVIATION 0.69 • n=5 Participants	1.25 mmol per Litre STANDARD_DEVIATION 0.72 • n=7 Participants	1.25 mmol per Litre STANDARD_DEVIATION 0.70 • n=5 Participants
Insulin (mU/L)	8.28 mU per Litre STANDARD_DEVIATION 9.70 • n=5 Participants	8.26 mU per Litre STANDARD_DEVIATION 12.9 • n=7 Participants	8.27 mU per Litre STANDARD_DEVIATION 11.4 • n=5 Participants
Glucose (mmol/L)	4.84 mmol per Litre STANDARD_DEVIATION 1.78 • n=5 Participants	4.66 mmol per Litre STANDARD_DEVIATION 0.98 • n=7 Participants	4.75 mmol per Litre STANDARD_DEVIATION 1.43 • n=5 Participants
Current smoker	87 participants n=5 Participants	82 participants n=7 Participants	169 participants n=5 Participants
Mean BMI (kg/m^2)	24.3 kg per m2 STANDARD_DEVIATION 5.2 • n=5 Participants	24.0 kg per m2 STANDARD_DEVIATION 4.7 • n=7 Participants	24.2 kg per m2 STANDARD_DEVIATION 4.9 • n=5 Participants

PRIMARY outcome

Timeframe: 48 weeks

Population: modified intention to treat including all randomised patients who took at least one dose of study medication AND attended at least one follow-up visit.

Percentage of participants in each of the treatment arms with centrally quantified plasma HIV-1 RNA viral load \<200 copies/mL 48 weeks after randomisation.

Outcome measures

Outcome measures
Measure	600mg Efavirenz n=309 Participants Efavirenz: 3 x EFV 200mg tablets once daily plus tenofovir/emtricitabine 300 mg/200 mg	400mg Efavirenz n=321 Participants Efavirenz: 2 x EFV 200mg tablets plus 1x matched EFV placebo tablet once daily plus tenofovir/emtricitabine 300 mg/200 mg
Percentage of Participants With Plasma HIV-1 RNA <200 Copies/mL 48 Weeks After Randomisation	92.2 percentage of participants Interval 89.2 to 95.2	94.1 percentage of participants Interval 91.5 to 96.7

SECONDARY outcome

Timeframe: Baseline and 2 years

Population: Modified ITT including all randomised participants who took at least one dose of study medication and attended at least one follow-up visit

Percentage of participants in each of the two treatment arms with plasma HIV-1 RNA \<400 copies/mL and \<50 copies/mL at 48 and 96 weeks after randomisation

Outcome measures

Outcome measures
Measure	600mg Efavirenz n=309 Participants Efavirenz: 3 x EFV 200mg tablets once daily plus tenofovir/emtricitabine 300 mg/200 mg	400mg Efavirenz n=321 Participants Efavirenz: 2 x EFV 200mg tablets plus 1x matched EFV placebo tablet once daily plus tenofovir/emtricitabine 300 mg/200 mg
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL and <50 Copies/mL at 48 and 96 Weeks After Randomisation HIV-1 RNA <50cp/mL	268 participants	277 participants
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL and <50 Copies/mL at 48 and 96 Weeks After Randomisation HIV-1 RNA <400cp/mL	280 participants	291 participants

SECONDARY outcome

Timeframe: Baseline and 2 years

Population: modified ITT (all participants who received at least one dose of study treatment and attended at least one follow up visit, irrespective of treatment received)

Mean change from baseline to week 96 in CD4+ T-cell count/mm3 between the two treatment arms

Outcome measures

Outcome measures
Measure	600mg Efavirenz n=309 Participants Efavirenz: 3 x EFV 200mg tablets once daily plus tenofovir/emtricitabine 300 mg/200 mg	400mg Efavirenz n=321 Participants Efavirenz: 2 x EFV 200mg tablets plus 1x matched EFV placebo tablet once daily plus tenofovir/emtricitabine 300 mg/200 mg
Mean Change From Baseline in CD4+ T-cell Count	209 cells per mm3 Interval 194.0 to 226.0	235 cells per mm3 Interval 218.0 to 252.0

SECONDARY outcome

Timeframe: up to 2 years

Population: modified ITT population

Number of participants in each randomised arm diagnosed with a serious non-AIDS defining event, who die from an AIDS-defining event, who die from a non-AIDS-defining event

Outcome measures

Outcome measures
Measure	600mg Efavirenz n=309 Participants Efavirenz: 3 x EFV 200mg tablets once daily plus tenofovir/emtricitabine 300 mg/200 mg	400mg Efavirenz n=321 Participants Efavirenz: 2 x EFV 200mg tablets plus 1x matched EFV placebo tablet once daily plus tenofovir/emtricitabine 300 mg/200 mg
Clinical Endpoints: Opportunistic Disease or Death, and Serious Non-AIDS-defining Events and Non-AIDS-related Mortality AIDS events	7 Participants	14 Participants
Clinical Endpoints: Opportunistic Disease or Death, and Serious Non-AIDS-defining Events and Non-AIDS-related Mortality AIDS event deaths	2 Participants	0 Participants
Clinical Endpoints: Opportunistic Disease or Death, and Serious Non-AIDS-defining Events and Non-AIDS-related Mortality non-AIDS deaths	5 Participants	3 Participants
Clinical Endpoints: Opportunistic Disease or Death, and Serious Non-AIDS-defining Events and Non-AIDS-related Mortality serious non-AIDS events	3 Participants	3 Participants
Clinical Endpoints: Opportunistic Disease or Death, and Serious Non-AIDS-defining Events and Non-AIDS-related Mortality No disease/death	292 Participants	301 Participants

SECONDARY outcome

Timeframe: Baseline and 2 years

Population: Available data analysis

Change from baseline to week 96 in fasted total cholesterol, high density cholesterol and low density cholesterol, and glucose between randomised treatment arms

Outcome measures

Outcome measures
Measure	600mg Efavirenz n=309 Participants Efavirenz: 3 x EFV 200mg tablets once daily plus tenofovir/emtricitabine 300 mg/200 mg	400mg Efavirenz n=321 Participants Efavirenz: 2 x EFV 200mg tablets plus 1x matched EFV placebo tablet once daily plus tenofovir/emtricitabine 300 mg/200 mg
Change From Baseline in Metabolic Endpoints Total cholesterol mmol/L	0.62 mmol per Litre Interval 0.53 to 0.71	0.54 mmol per Litre Interval 0.44 to 0.63
Change From Baseline in Metabolic Endpoints HDL mmol/L	0.35 mmol per Litre Interval 0.31 to 0.4	0.30 mmol per Litre Interval 0.26 to 0.34
Change From Baseline in Metabolic Endpoints LDL mmol/L	0.21 mmol per Litre Interval 0.13 to 0.29	0.16 mmol per Litre Interval 0.09 to 0.23
Change From Baseline in Metabolic Endpoints Blood glucose mmol/L	0.24 mmol per Litre Interval 0.07 to 0.4	0.40 mmol per Litre Interval 0.3 to 0.5

SECONDARY outcome

Timeframe: 2 years

Population: Number of participants attending week 96 visit

AIDS Clinical Trials Group (ACTG) 7-day adherence questionnaire scores. Maximum value is all pills taken every day; minimum value is no pills taken per day. Higher scores indicate a better outcome.

Outcome measures

Outcome measures
Measure	600mg Efavirenz n=280 Participants Efavirenz: 3 x EFV 200mg tablets once daily plus tenofovir/emtricitabine 300 mg/200 mg	400mg Efavirenz n=292 Participants Efavirenz: 2 x EFV 200mg tablets plus 1x matched EFV placebo tablet once daily plus tenofovir/emtricitabine 300 mg/200 mg
Adherence: Median Scores of Self-reported Adherence to Randomised Study Medications All pills taken	256 Participants	271 Participants
Adherence: Median Scores of Self-reported Adherence to Randomised Study Medications Most pills taken	7 Participants	12 Participants
Adherence: Median Scores of Self-reported Adherence to Randomised Study Medications About half pills taken	1 Participants	1 Participants
Adherence: Median Scores of Self-reported Adherence to Randomised Study Medications No pills taken	16 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline and 2 years

Population: Available data analysis

Change from baseline to week 96 in fasted insulin levels

Outcome measures

Outcome measures
Measure	600mg Efavirenz n=309 Participants Efavirenz: 3 x EFV 200mg tablets once daily plus tenofovir/emtricitabine 300 mg/200 mg	400mg Efavirenz n=321 Participants Efavirenz: 2 x EFV 200mg tablets plus 1x matched EFV placebo tablet once daily plus tenofovir/emtricitabine 300 mg/200 mg
Change From Baseline in Fasted Insulin Levels	-0.11 mU per litre Interval -0.23 to 1.02	0.3 mU per litre Interval -1.81 to 2.42

SECONDARY outcome

Timeframe: Baseline and 2 years

Population: Available data analysis

Change from baseline to week 96 in alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase levels between randomised treatment arms

Outcome measures

Outcome measures
Measure	600mg Efavirenz n=309 Participants Efavirenz: 3 x EFV 200mg tablets once daily plus tenofovir/emtricitabine 300 mg/200 mg	400mg Efavirenz n=321 Participants Efavirenz: 2 x EFV 200mg tablets plus 1x matched EFV placebo tablet once daily plus tenofovir/emtricitabine 300 mg/200 mg
Change in Selected Serum Biochemical Parameters Alanine aminotransferase	6.53 Units per Litre Interval 1.04 to 12.02	0.64 Units per Litre Interval -3.52 to 4.79
Change in Selected Serum Biochemical Parameters Aspartate aminotransferase	1.71 Units per Litre Interval -1.69 to 5.1	-1.23 Units per Litre Interval -3.67 to 1.21
Change in Selected Serum Biochemical Parameters Alkaline phosphatase	26.75 Units per Litre Interval 22.9 to 30.61	21.23 Units per Litre Interval 17.4 to 25.05

SECONDARY outcome

Timeframe: Baseline and 2 years

Population: Available data analysis

Change from baseline to week 96 in estimate creatinine clearance between randomised treatment arms

Outcome measures

Outcome measures
Measure	600mg Efavirenz n=309 Participants Efavirenz: 3 x EFV 200mg tablets once daily plus tenofovir/emtricitabine 300 mg/200 mg	400mg Efavirenz n=321 Participants Efavirenz: 2 x EFV 200mg tablets plus 1x matched EFV placebo tablet once daily plus tenofovir/emtricitabine 300 mg/200 mg
Change From Baseline in Estimate Creatinine Clearance	-0.17 millilitres per minute Interval -2.45 to 2.1	1.59 millilitres per minute Interval -1.05 to 4.24

SECONDARY outcome

Timeframe: Week 4

Population: Available data analysis

Steady-state efavirenz mid-dosing interval plasma concentrations

Outcome measures

Outcome measures
Measure	600mg Efavirenz n=295 Participants Efavirenz: 3 x EFV 200mg tablets once daily plus tenofovir/emtricitabine 300 mg/200 mg	400mg Efavirenz n=311 Participants Efavirenz: 2 x EFV 200mg tablets plus 1x matched EFV placebo tablet once daily plus tenofovir/emtricitabine 300 mg/200 mg
Steady-state Efavirenz Concentrations	2.85 milligram per Litre Interval 2.7 to 3.0	2.10 milligram per Litre Interval 2.01 to 2.2

Adverse Events

600mg Efavirenz

Serious events: 25 serious events

Other events: 273 other events

Deaths: 7 deaths

400mg Efavirenz

Serious events: 23 serious events

Other events: 286 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	600mg Efavirenz n=309 participants at risk Eligible patients will be centrally randomised to receive tenofovir (TDF) (300mg qd)/emtricitabine (FTC) (200mg qd) + EFV (600mg qd; 3 x 200mg qd) Efavirenz: 3 x EFV 200mg tablets once daily	400mg Efavirenz n=321 participants at risk Eligible patients will be centrally randomised to receive TDF (300mg qd)/FTC (200mg qd) + EFV (400mg qd; 2 x 200mg + 1 x 200mg placebo qd). Efavirenz: 2 x EFV 200mg tablets plus 1x matched EFV placebo tablet once daily
Infections and infestations upper respiratory tract infection	11.7% 36/309 • Number of events 41 • 96 weeks. Analyses were modified intention-to-treat which included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in the modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg Adverse event analysis included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in this modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg	17.8% 57/321 • Number of events 68 • 96 weeks. Analyses were modified intention-to-treat which included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in the modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg Adverse event analysis included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in this modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg
Infections and infestations nasopharyngitis	5.8% 18/309 • Number of events 26 • 96 weeks. Analyses were modified intention-to-treat which included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in the modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg Adverse event analysis included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in this modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg	8.1% 26/321 • Number of events 30 • 96 weeks. Analyses were modified intention-to-treat which included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in the modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg Adverse event analysis included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in this modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg
Infections and infestations influenza	5.5% 17/309 • Number of events 22 • 96 weeks. Analyses were modified intention-to-treat which included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in the modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg Adverse event analysis included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in this modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg	5.6% 18/321 • Number of events 23 • 96 weeks. Analyses were modified intention-to-treat which included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in the modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg Adverse event analysis included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in this modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg
Infections and infestations gastroenteritis	4.2% 13/309 • Number of events 13 • 96 weeks. Analyses were modified intention-to-treat which included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in the modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg Adverse event analysis included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in this modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg	5.3% 17/321 • Number of events 19 • 96 weeks. Analyses were modified intention-to-treat which included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in the modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg Adverse event analysis included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in this modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg
Vascular disorders dizziness	34.6% 107/309 • Number of events 121 • 96 weeks. Analyses were modified intention-to-treat which included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in the modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg Adverse event analysis included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in this modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg	26.5% 85/321 • Number of events 96 • 96 weeks. Analyses were modified intention-to-treat which included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in the modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg Adverse event analysis included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in this modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg
Gastrointestinal disorders diarrhoea	11.7% 36/309 • Number of events 40 • 96 weeks. Analyses were modified intention-to-treat which included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in the modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg Adverse event analysis included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in this modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg	10.3% 33/321 • Number of events 38 • 96 weeks. Analyses were modified intention-to-treat which included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in the modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg Adverse event analysis included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in this modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg
Gastrointestinal disorders nausea	7.1% 22/309 • Number of events 24 • 96 weeks. Analyses were modified intention-to-treat which included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in the modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg Adverse event analysis included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in this modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg	4.4% 14/321 • Number of events 15 • 96 weeks. Analyses were modified intention-to-treat which included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in the modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg Adverse event analysis included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in this modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg
Skin and subcutaneous tissue disorders rash	13.3% 41/309 • Number of events 44 • 96 weeks. Analyses were modified intention-to-treat which included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in the modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg Adverse event analysis included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in this modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg	17.8% 57/321 • Number of events 65 • 96 weeks. Analyses were modified intention-to-treat which included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in the modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg Adverse event analysis included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in this modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg
Psychiatric disorders abnormal dreams	11.3% 35/309 • Number of events 35 • 96 weeks. Analyses were modified intention-to-treat which included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in the modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg Adverse event analysis included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in this modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg	8.7% 28/321 • Number of events 29 • 96 weeks. Analyses were modified intention-to-treat which included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in the modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg Adverse event analysis included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in this modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg
Psychiatric disorders insomnia	6.5% 20/309 • Number of events 21 • 96 weeks. Analyses were modified intention-to-treat which included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in the modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg Adverse event analysis included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in this modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg	6.2% 20/321 • Number of events 21 • 96 weeks. Analyses were modified intention-to-treat which included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in the modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg Adverse event analysis included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in this modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg
Nervous system disorders headache	11.0% 34/309 • Number of events 40 • 96 weeks. Analyses were modified intention-to-treat which included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in the modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg Adverse event analysis included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in this modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg	10.9% 35/321 • Number of events 44 • 96 weeks. Analyses were modified intention-to-treat which included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in the modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg Adverse event analysis included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in this modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg
Respiratory, thoracic and mediastinal disorders cough	6.1% 19/309 • Number of events 19 • 96 weeks. Analyses were modified intention-to-treat which included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in the modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg Adverse event analysis included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in this modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg	5.9% 19/321 • Number of events 20 • 96 weeks. Analyses were modified intention-to-treat which included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in the modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg Adverse event analysis included all randomised participants who received at least one dose of study drug and had at least one follow-up visit. Number of participants in this modified ITT analysis at week 96 are: 321 for EFV 400mg and 309 for EFV 600mg

Additional Information

Sean Emery

University of New South Wales

Phone: 02 9385 0900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place