Trial Outcomes & Findings for Efavirenz (EFV) Intensification (NCT NCT07193875)

NCT ID: NCT07193875

Last Updated: 2026-07-17

Results Overview

Safety as measured by number of serious adverse events, adverse events leading to study discontinuation or adverse events considered clinically significant

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

9 participants

Primary outcome timeframe

From time of enrollment until completion of study on average 5 months

Results posted on

2026-07-17

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm, Pre and Post Intervention of ART Intensification With Efavirenz Participants undergo baseline leukapheresis and then undergo intensification with daily Efavirenz during study period (\~4mo) and then a completion leukapheresis.
Overall Study STARTED	9
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efavirenz (EFV) Intensification

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm, Pre and Post Intervention of ART Intensification With Efavirenz n=7 Participants Participants undergo baseline leukapheresis and then undergo intensification with daily Efavirenz during study period (\~4mo) and then a completion leukapheresis.
Age, Categorical <=18 years	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=20 Participants
Age, Categorical >=65 years	0 Participants n=20 Participants
Age, Continuous	47.8 years STANDARD_DEVIATION 12.2 • n=20 Participants
Sex: Female, Male Female	0 Participants n=20 Participants
Sex: Female, Male Male	7 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	5 Participants n=20 Participants
Race (NIH/OMB) White	2 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants
Region of Enrollment United States	7 Participants n=20 Participants
intact proviral DNA reservoir (IPDA )-PRE	236.9 CD4 cells w/ intact provirus/mil CD4 T n=20 Participants

PRIMARY outcome

Timeframe: From time of enrollment until completion of study on average 5 months

Safety as measured by number of serious adverse events, adverse events leading to study discontinuation or adverse events considered clinically significant

Outcome measures

Outcome measures
Measure	Single Arm, Pre and Post Intervention of ART Intensification With Efavirenz n=7 Participants Participants undergo baseline leukapheresis and then undergo intensification with daily Efavirenz during study period (\~4mo) and then a completion leukapheresis. Safety is measured using self reported events, DIADS scores and PHQ9
Safety as Measured by Adverse Events Serious adverse events	1 Participants
Safety as Measured by Adverse Events Other (Not Including Serious) Adverse Events	0 Participants
Safety as Measured by Adverse Events All-Cause Mortality	0 Participants

PRIMARY outcome

Timeframe: (1) at study enrolment and (2) 4 months post EFV intensification

Population: intact proviral DNA reservoir (IPDA )

Size of intact provirus pre and post Efavirenz intensification as measured by IPDA. (CD4 cells with intact provirus/million CD4T cells) Time frame: IPDA (CD4 T cells carrying intact HIV provirus per million total CD4 T cells) at least of two time points (1) at study enrolment and (2) 4 months post EFV intensification

Outcome measures

Outcome measures
Measure	Single Arm, Pre and Post Intervention of ART Intensification With Efavirenz n=7 Participants Participants undergo baseline leukapheresis and then undergo intensification with daily Efavirenz during study period (\~4mo) and then a completion leukapheresis. Safety is measured using self reported events, DIADS scores and PHQ9
Size of the Latent Reservoir (Cluster of Differentiation 4 (CD4) Cells With Intact Provirus/Million CD4 T Cells) Pre	236.9 CD4 cells w/ intact provirus/mil CD4 T Interval 56.0 to 613.0
Size of the Latent Reservoir (Cluster of Differentiation 4 (CD4) Cells With Intact Provirus/Million CD4 T Cells) Post	155.8 CD4 cells w/ intact provirus/mil CD4 T Interval 47.0 to 512.0

Adverse Events

Single Arm, Pre and Post Intervention of ART Intensification With Efavirenz

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm, Pre and Post Intervention of ART Intensification With Efavirenz n=7 participants at risk Participants undergo baseline leukapheresis and then undergo intensification with daily Efavirenz during study period (\~4mo) and then a completion leukapheresis.
Hepatobiliary disorders Hepatotoxicity	14.3% 1/7 • Number of events 1 • Safety events were monitored throughout study period The # of patient reported or laboratory adverse events of grade II or higher as scored by Division of AIDS (DAIDS) throughout the study (average 5 months) which includes monthly check-ins while on study

Other adverse events

Adverse event data not reported

Additional Information

Priya Pal

Washington University in St Louis

Phone: 314-454-0058

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place