Trial Outcomes & Findings for Virological and Immunological Safety of a Dose Reduction Strategy Antiretroviral Regimen With Efavirenz / Tenofovir / Emtricitabine (NCT NCT01778413)

Results Overview

Treatment failure defined as any of the following possibilities occurring within the 24-week study framework: virological failure (confirmed plasma viral load 37 copies/ml), discontinuation of the antiretroviral therapy schedule irrespective of the reason, consent withdrawal, lost to follow-up, pregnancy, inability to comply with the study or any other reason that could make the doctor in charge consider the cessation of the study.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

61 participants

Primary outcome timeframe

24 weeks

Results posted on

2025-07-18

Participant Flow

Participants were recruited between 3 June 2013 and 30 May 2014 at Hospital Clínic of Barcelona.

68 patients were assessed for eligibility, 61 underwent randomization and received at least one dose of study drugs. Seven patients were excluded because of refusal to participate (lack of time, n¼4; lack of interest, n¼1; fear of viral failure, n¼1) or evidence of illicit drug consumption (n¼1).

Participant milestones

Participant milestones
Measure	ATRIPLA Three Days a Week (3W) Atripla (600 mg/200 mg/245 mg) three days a week (Mondays, Wednesdays and Fridays).	ATRIPLA One Time a Day (OD) Atripla (600 mg/200 mg/245 mg) one time a day.
Overall Study STARTED	30	31
Overall Study COMPLETED	30	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Virological and Immunological Safety of a Dose Reduction Strategy Antiretroviral Regimen With Efavirenz / Tenofovir / Emtricitabine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ATRIPLA Three Days a Week (3W) n=30 Participants Atripla (600 mg/200 mg/245 mg) three days a week (Mondays, Wednesdays and Fridays).	ATRIPLA One Time a Day (OD) n=31 Participants Atripla (600 mg/200 mg/245 mg) one time a day.	Total n=61 Participants Total of all reporting groups
Age, Continuous	47.8 years n=5 Participants	48.5 years n=7 Participants	48.2 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Caucasian	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Treatment failure defined as any of the following possibilities occurring within the 24-week study framework: virological failure (confirmed plasma viral load 37 copies/ml), discontinuation of the antiretroviral therapy schedule irrespective of the reason, consent withdrawal, lost to follow-up, pregnancy, inability to comply with the study or any other reason that could make the doctor in charge consider the cessation of the study.

Outcome measures

Outcome measures
Measure	ATRIPLA Three Days a Week (3W) n=30 Participants Atripla (600 mg/200 mg/245 mg) three days a week (Mondays, Wednesdays and Fridays).	ATRIPLA One Time a Day (OD) n=31 Participants Atripla (600 mg/200 mg/245 mg) one time a day.
Proportion of Patients Free of Treatment Failure (Noncompleter = Failure) at 24 Weeks. Patients free of treatment failure	30 Participants	31 Participants
Proportion of Patients Free of Treatment Failure (Noncompleter = Failure) at 24 Weeks. Patients with treatment failure	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and 6 months

ATRIPLA Three Days a Week (3W)

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

ATRIPLA One Time a Day (OD)

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ATRIPLA Three Days a Week (3W) n=30 participants at risk Atripla (600 mg/200 mg/245 mg) three days a week (Mondays, Wednesdays and Fridays).	ATRIPLA One Time a Day (OD) n=31 participants at risk Atripla (600 mg/200 mg/245 mg) one time a day.
General disorders Mild, non-serious adverse events	43.3% 13/30 • Number of events 13 • 24 weeks AE/SAE definitions were consistent with ClinicalTrials.gov, but also included clinically significant lab abnormalities and events related to overdose, abuse, or withdrawal. AEs were collected systematically at baseline, weeks 12 and 24 in both arms, and at weeks 1, 2, 4, 6, and 8 in the 3-day/week arm. Grading used DAIDS Table v1.0 (Dec 2004; Clarified Aug 2009).	35.5% 11/31 • Number of events 11 • 24 weeks AE/SAE definitions were consistent with ClinicalTrials.gov, but also included clinically significant lab abnormalities and events related to overdose, abuse, or withdrawal. AEs were collected systematically at baseline, weeks 12 and 24 in both arms, and at weeks 1, 2, 4, 6, and 8 in the 3-day/week arm. Grading used DAIDS Table v1.0 (Dec 2004; Clarified Aug 2009).

Additional Information

Dr. Esteban Martinez

Hospital Clínic de Barcelona

Phone: 932275400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place