Trial Outcomes & Findings for Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients (NCT NCT01989910)

NCT ID: NCT01989910

Last Updated: 2019-02-25

Results Overview

Virological response to achieve HIV RNA copies \<20 copies/mL at week 48 of both arms.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 107 participants
• Primary outcome timeframe: At week 48 of both arms
• Results posted on: 2019-02-25

Participant Flow

Participant milestones

Measure	Raltegravir Raltegravir 400mg oral twice daily Efavirenz: Efavirenz 600mg oral at bedtime	Efavirenz Efavirenz 600mg oral at bedtime Raltegravir: Raltegravir 400mg oral twice daily
Overall Study STARTED	53	54
Overall Study COMPLETED	51	54
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients

Baseline characteristics by cohort

Measure	Raltegravir n=51 Participants Raltegravir 400mg oral twice daily Efavirenz: Efavirenz 600mg oral at bedtime	Efavirenz n=54 Participants Efavirenz 600mg oral at bedtime Raltegravir: Raltegravir 400mg oral twice daily	Total n=105 Participants Total of all reporting groups
Age, Continuous	31 years n=5 Participants	33 years n=7 Participants	32 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	52 Participants n=7 Participants	102 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	51 Participants n=5 Participants	54 Participants n=7 Participants	105 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline VL >100,000 copies/mL	27 Participants n=5 Participants	28 Participants n=7 Participants	55 Participants n=5 Participants

PRIMARY outcome

Timeframe: At week 48 of both arms

Virological response to achieve HIV RNA copies <20 copies/mL at week 48 of both arms.

Outcome measures

Measure	Raltegravir n=51 Participants Raltegravir 400mg oral twice daily Efavirenz: Efavirenz 600mg oral at bedtime	Efavirenz n=54 Participants Efavirenz 600mg oral at bedtime Raltegravir: Raltegravir 400mg oral twice daily
The Proportion of Patients Who Can Achieve of Less Than 20 HIV RNA Copies Per ml at Week 48 of Both Arms.	41 Participants	36 Participants

SECONDARY outcome

Timeframe: At week 48 of both arms

Virological response to achieve HIV RNA copies <400 copies/mL at week 48 of both arms.

Outcome measures

Measure	Raltegravir n=51 Participants Raltegravir 400mg oral twice daily Efavirenz: Efavirenz 600mg oral at bedtime	Efavirenz n=54 Participants Efavirenz 600mg oral at bedtime Raltegravir: Raltegravir 400mg oral twice daily
The Proportion of Patients With Achievement of Less Than 400 HIV RNA Copies Per ml at Week 48 for Both Arms.	41 Participants	36 Participants

SECONDARY outcome

Timeframe: At week 48 of both arms.

The change from baseline in cluster of differentiation 4(CD4) cell counts at week 48 for both arms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At week 48 of both arms

The proportion of treatment failure, defined as detectable HIV RNA copies copies/mL, at week 48 for both arms.

Outcome measures

Measure	Raltegravir n=51 Participants Raltegravir 400mg oral twice daily Efavirenz: Efavirenz 600mg oral at bedtime	Efavirenz n=54 Participants Efavirenz 600mg oral at bedtime Raltegravir: Raltegravir 400mg oral twice daily
The Proportion of Treatment Failure at Week 48 for Both Arms.	2 Participants	2 Participants

Adverse Events

Raltegravir

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Efavirenz

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Raltegravir n=51 participants at risk Raltegravir 400mg oral twice daily Efavirenz: Efavirenz 600mg oral at bedtime	Efavirenz n=54 participants at risk Efavirenz 600mg oral at bedtime Raltegravir: Raltegravir 400mg oral twice daily
Nervous system disorders Insomnia	0.00% 0/51	11.1% 6/54
Musculoskeletal and connective tissue disorders CK Elevation	2.0% 1/51	0.00% 0/54
Skin and subcutaneous tissue disorders Rash	0.00% 0/51	3.7% 2/54
Blood and lymphatic system disorders Anemia	3.9% 2/51	0.00% 0/54
Blood and lymphatic system disorders Eosinophilia	0.00% 0/51	1.9% 1/54
Metabolism and nutrition disorders Hypertriglycemia	2.0% 1/51	0.00% 0/54
Gastrointestinal disorders Swallowing Difficulties	0.00% 0/51	1.9% 1/54

Additional Information

Dr. WEN-WEI KU

Taipei Veterans General Hospital

Phone: +886228751997

Email: stephaneku@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place