Trial Outcomes & Findings for Impact of a Dolutegravir-based Regimen on Early Mortality of AIDS Patients (NCT NCT01837277)

NCT ID: NCT01837277

Last Updated: 2023-12-14

Results Overview

Proportion of deaths in each group

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 186 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2023-12-14

Participant Flow

Participant milestones

Measure	Dolutegravir Intervention: Patients will receive ART regimen based on investigational drug Dolutegravir 50 mg QD + TDF 300 mg QD+ 3TC 150 mg BID Dolutegravir 50 mg: Use of Dolutegravir -based regimens: patients will receive a Dolutegravir -based ART regimen (RAL 400 mg BID + TDF 300 mg QD + 3TC 150 mg BID)	Efavirenz Intervention: Patients who received ART regimen based efavirenz (EFV 600 mg QD +TDF 300 mg QD+ 3TC 300 mg QD) for one year, befor the use of DTG as SOC for first-line therapy (historic controls) Efavirenz-based regimens: Efavirenz-based regimens: patients will receive an EFV-based regimen (EFV 600 mg QD + TDGF 300 mg QD + 3TC 300 mg QD)
Overall Study STARTED	92	92
Overall Study COMPLETED	70	48
Overall Study NOT COMPLETED	22	44

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of a Dolutegravir-based Regimen on Early Mortality of AIDS Patients

Baseline characteristics by cohort

Measure	Efavirenz n=92 Participants Intervention: Patients who received ART regimen based efavirenz (EFV 600 mg QD +TDF 300 mg QD+ 3TC 300 mg QD) for one year, befor the use of DTG as SOC for first-line therapy (historic controls) Efavirenz-based regimens: Efavirenz-based regimens: patients will receive an EFV-based regimen (EFV 600 mg QD + TDGF 300 mg QD + 3TC 300 mg QD)	Dolutegravir n=92 Participants Intervention: Patients will receive ART regimen based on investigational drug Dolutegravir 50 mg QD + TDF 300 mg QD+ 3TC 150 mg BID Dolutegravir 50 mg: Use of Dolutegravir -based regimens: patients will receive a Dolutegravir -based ART regimen (RAL 400 mg BID + TDF 300 mg QD + 3TC 150 mg BID)	Total n=184 Participants Total of all reporting groups
Age, Continuous	37.3 years STANDARD_DEVIATION 8.9 • n=5 Participants	39.3 years STANDARD_DEVIATION 11.5 • n=7 Participants	38.3 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	63 Participants n=7 Participants	96 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants	29 Participants n=7 Participants	88 Participants n=5 Participants
Race/Ethnicity, Customized White	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Race/Ethnicity, Customized Black	15 Participants n=5 Participants	5 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Race/Ethnicity, Customized Not reported	28 Participants n=5 Participants	48 Participants n=7 Participants	76 Participants n=5 Participants
Region of Enrollment Brazil	92 Participants n=5 Participants	92 Participants n=7 Participants	184 Participants n=5 Participants
CD4 (cell/mm3)	23 cells/mm3 STANDARD_DEVIATION 14 • n=5 Participants	23 cells/mm3 STANDARD_DEVIATION 14 • n=7 Participants	23 cells/mm3 STANDARD_DEVIATION 14 • n=5 Participants
Viral load (copies/mL	5.6 log 10 copies/ml n=5 Participants	5.5 log 10 copies/ml n=7 Participants	5.5 log 10 copies/ml n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Proportion of deaths in each group

Outcome measures

Measure	Dolutegravir n=92 Participants Patients treated with Dolutegravir	Efavirenz n=92 Participants Patients treated with Efavirenz
Early Mortality	9 Participants	13 Participants

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Outcome data not reported

Adverse Events

Dolutegravir

Serious events: 9 serious events

Other events: 0 other events

Deaths: 9 deaths

Efavirenz

Serious events: 13 serious events

Other events: 11 other events

Deaths: 13 deaths

Serious adverse events

Measure	Dolutegravir n=92 participants at risk Patients treated with Dolutegravir	Efavirenz n=92 participants at risk Patients treated with Efavirenz
General disorders death	9.8% 9/92 • Adverse events leading to interruption/change of ART in the 48 weeks period Proportion of adverse events leading to ART interruption were recorded, by group	14.1% 13/92 • Adverse events leading to interruption/change of ART in the 48 weeks period Proportion of adverse events leading to ART interruption were recorded, by group

Other adverse events

Measure	Dolutegravir n=92 participants at risk Patients treated with Dolutegravir	Efavirenz n=92 participants at risk Patients treated with Efavirenz
Psychiatric disorders CNS disturbances	0.00% 0/92 • Adverse events leading to interruption/change of ART in the 48 weeks period Proportion of adverse events leading to ART interruption were recorded, by group	12.0% 11/92 • Adverse events leading to interruption/change of ART in the 48 weeks period Proportion of adverse events leading to ART interruption were recorded, by group

Additional Information

Professor Carlos Brites

Federal University of Bahia

Phone: +5555992329552

Email: crbrites@hotmail.com

Results disclosure agreements

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