Trial Outcomes & Findings for The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection (NCT NCT00641641)

Results Overview

change was calculated as the mean of 12 assessments minus the baseline value

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

12 times within 48 weeks.

Results posted on

2017-08-31

Patients were recruited at 5 clinical centres in Sydney

A screening period of less than 42 days prior to commencement of study drugs was employed

Participant milestones
Measure	Drug Intervention Tenofovir+emtricitabine+raltegravir
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Withdrawal data not reported

The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection

Baseline characteristics by cohort
Measure	Drug Intervention n=16 Participants Tenofovir+emtricitabine+raltegravir
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment Australia	16 participants n=5 Participants

Timeframe: 12 times within 48 weeks.

Population: Intention to treat

change was calculated as the mean of 12 assessments minus the baseline value

Outcome measures
Measure	Drug Intervention n=16 Participants Tenofovir+emtricitabine+raltegravir
Mean Change From Baseline Plasma HIV RNA (Log Copies/mL)	5.4 log copies/mL plasma Standard Deviation 0.6

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of New South Wales

Phone: 9385 0900