Trial Outcomes & Findings for Population Effectiveness of Dolutegravir Implementation in Sub-Saharan Africa (NCT NCT04066036)
NCT ID: NCT04066036
Last Updated: 2026-08-05
Results Overview
HIV-1 RNA \>= 200 copies/mL
Recruitment status
COMPLETED
Target enrollment
999 participants
Primary outcome timeframe
48 weeks
Results posted on
2026-08-05
Participant Flow
Participant milestones
| Measure |
Study Population
The study will enroll a total of 1,000 ART-experienced participants from the study sites in Uganda and South Africa who are being transitioned to TLD from non-nucleoside reverse transcriptase-based antiretroviral therapy.
This is an observational study only.: This is an observational study only.
|
|---|---|
|
Overall Study
STARTED
|
999
|
|
Overall Study
COMPLETED
|
913
|
|
Overall Study
NOT COMPLETED
|
86
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Population Effectiveness of Dolutegravir Implementation in Sub-Saharan Africa
Baseline characteristics by cohort
| Measure |
Study Population
n=999 Participants
The study will enroll a total of 1,000 ART-experienced participants from the study sites in Uganda and South Africa who are being transitioned to TLD from non-nucleoside reverse transcriptase-based antiretroviral therapy.
This is an observational study only.: This is an observational study only.
|
|---|---|
|
Age, Continuous
|
44 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
606 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
393 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
|
999 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
0 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
Uganda
|
500 participants
n=20 Participants
|
|
Region of Enrollment
South Africa
|
499 participants
n=20 Participants
|
|
Marital Status
Single
|
626 Participants
n=20 Participants
|
|
Marital Status
Married/domestic partnership
|
373 Participants
n=20 Participants
|
|
Education Level
No Schooling
|
109 Participants
n=20 Participants
|
|
Education Level
Primary
|
341 Participants
n=20 Participants
|
|
Education Level
Secondary
|
441 Participants
n=20 Participants
|
|
Education Level
Tertiary
|
108 Participants
n=20 Participants
|
|
Years on ART
|
7.4 years
n=20 Participants
|
|
ART regimen prior to TLD
Efavirenz-containing regimen
|
783 Participants
n=20 Participants
|
|
ART regimen prior to TLD
Nevirapine-containing regimen
|
214 Participants
n=20 Participants
|
|
ART regimen prior to TLD
Unknown
|
2 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 48 weeksHIV-1 RNA \>= 200 copies/mL
Outcome measures
| Measure |
Study Population
n=999 Participants
The study will enroll a total of 1,000 ART-experienced participants from the study sites in Uganda and South Africa who are being transitioned to TLD from non-nucleoside reverse transcriptase-based antiretroviral therapy.
This is an observational study only.: This is an observational study only.
|
48 Week Outcome
Proportion of participants with HIV drug resistance at 48 weeks
|
|---|---|---|
|
Proportion of Participants With Virologic Failure (HIV-1 RNA >= 200 Copies/mL)
|
28 Participants
|
—
|
SECONDARY outcome
Timeframe: 48 weeksHIV-1 RNA \>= 1,000 copies/mL
Outcome measures
| Measure |
Study Population
n=999 Participants
The study will enroll a total of 1,000 ART-experienced participants from the study sites in Uganda and South Africa who are being transitioned to TLD from non-nucleoside reverse transcriptase-based antiretroviral therapy.
This is an observational study only.: This is an observational study only.
|
48 Week Outcome
Proportion of participants with HIV drug resistance at 48 weeks
|
|---|---|---|
|
Proportion of Participants With Virologic Failure (HIV-1 RNA >= 1,000 Copies/mL)
|
18 Participants
|
—
|
SECONDARY outcome
Timeframe: 24 and 48 weeksProportion of participants with International AIDS Society-defined drug resistance mutations to their current regimen
Outcome measures
| Measure |
Study Population
n=999 Participants
The study will enroll a total of 1,000 ART-experienced participants from the study sites in Uganda and South Africa who are being transitioned to TLD from non-nucleoside reverse transcriptase-based antiretroviral therapy.
This is an observational study only.: This is an observational study only.
|
48 Week Outcome
n=999 Participants
Proportion of participants with HIV drug resistance at 48 weeks
|
|---|---|---|
|
Proportion of Participants With HIV Drug Resistance
|
2 Participants
|
3 Participants
|
Adverse Events
Study Population
Serious events: 12 serious events
Other events: 0 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Study Population
n=999 participants at risk
The study will enroll a total of 1,000 ART-experienced participants from the study sites in Uganda and South Africa who are being transitioned to TLD from non-nucleoside reverse transcriptase-based antiretroviral therapy.
This is an observational study only.: This is an observational study only.
|
|---|---|
|
Social circumstances
Death
|
0.20%
2/999 • Adverse event data were collected passively over 48 weeks of study participation.
|
|
Blood and lymphatic system disorders
Death
|
0.10%
1/999 • Adverse event data were collected passively over 48 weeks of study participation.
|
|
General disorders
Death
|
0.30%
3/999 • Adverse event data were collected passively over 48 weeks of study participation.
|
|
Infections and infestations
Death
|
0.10%
1/999 • Adverse event data were collected passively over 48 weeks of study participation.
|
|
Respiratory, thoracic and mediastinal disorders
Death
|
0.10%
1/999 • Adverse event data were collected passively over 48 weeks of study participation.
|
|
Infections and infestations
Hospitalization
|
0.20%
2/999 • Adverse event data were collected passively over 48 weeks of study participation.
|
|
Injury, poisoning and procedural complications
Hospitalization
|
0.10%
1/999 • Adverse event data were collected passively over 48 weeks of study participation.
|
|
Endocrine disorders
Hospitalization
|
0.10%
1/999 • Adverse event data were collected passively over 48 weeks of study participation.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place