Trial Outcomes & Findings for INSTI's For The Management of HIV-associated TB (NCT NCT04734652)
NCT ID: NCT04734652
Last Updated: 2025-10-03
Results Overview
Viral suppression rate (HIV-1 RNA \<50 copies/mL) at week 24 in the BIC arm (using the FDA snapshot algorithm).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
122 participants
Primary outcome timeframe
Week 24
Results posted on
2025-10-03
Participant Flow
Potential study participants were recruited from pre-approved clinics and hospitals. A pre-screening checklist was utilized by the Recruiters to select potential study participants.
Participant milestones
| Measure |
BIC Arm
The Intervention Arm ART regimen is a fixed-drug combination of a single tablet co-formulated regimen containing Bictegravir 50mg Emtricitabine 200mg and tenofovir alafenamide 25mg (BIC/FTC/TAF; Biktarvy®) that will be taken twice a day during rifampicin-containing TB treatment and 2 weeks after stopping TB treatment, thereafter the BIC/FTC/TAF single tablet co-formulation will be taken once daily.
|
DTG Arm
Dolutegravir 50mg /Lamivudine 300mg/ Tenofovir 300mg (TLD- fixed-drug combination single tablet) plus Dolutegravir 50mg evening dose during TB treatment and for two weeks after completion of TB treatment, then TLD once daily thereafter- as per Standard of Care (SOC)
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
42
|
|
Overall Study
COMPLETED
|
78
|
41
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
BIC Arm
The Intervention Arm ART regimen is a fixed-drug combination of a single tablet co-formulated regimen containing Bictegravir 50mg Emtricitabine 200mg and tenofovir alafenamide 25mg (BIC/FTC/TAF; Biktarvy®) that will be taken twice a day during rifampicin-containing TB treatment and 2 weeks after stopping TB treatment, thereafter the BIC/FTC/TAF single tablet co-formulation will be taken once daily.
|
DTG Arm
Dolutegravir 50mg /Lamivudine 300mg/ Tenofovir 300mg (TLD- fixed-drug combination single tablet) plus Dolutegravir 50mg evening dose during TB treatment and for two weeks after completion of TB treatment, then TLD once daily thereafter- as per Standard of Care (SOC)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
INSTI's For The Management of HIV-associated TB
Baseline characteristics by cohort
| Measure |
BIC Arm
n=80 Participants
The Intervention Arm ART regimen is a fixed-drug combination of a single tablet co-formulated regimen containing Bictegravir 50mg Emtricitabine 200mg and tenofovir alafenamide 25mg (BIC/FTC/TAF; Biktarvy®) that will be taken twice a day during rifampicin-containing TB treatment and 2 weeks after stopping TB treatment, thereafter the BIC/FTC/TAF single tablet co-formulation will be taken once daily.
|
DTG Arm
n=42 Participants
Dolutegravir 50mg /Lamivudine 300mg/ Tenofovir 300mg (TLD- fixed-drug combination single tablet) plus Dolutegravir 50mg evening dose during TB treatment and for two weeks after completion of TB treatment, then TLD once daily thereafter- as per Standard of Care (SOC)
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
80 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
79 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
80 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
122 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
|
|
Region of Enrollment
South Africa
|
80 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Age, median range
|
35 years
n=5 Participants
|
35 years
n=7 Participants
|
35 years
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Viral suppression rate (HIV-1 RNA \<50 copies/mL) at week 24 in the BIC arm (using the FDA snapshot algorithm).
Outcome measures
| Measure |
BIC Arm
n=80 Participants
The Intervention Arm ART regimen is a fixed-drug combination of a single tablet co-formulated regimen containing Bictegravir 50mg Emtricitabine 200mg and tenofovir alafenamide 25mg (BIC/FTC/TAF; Biktarvy®) that will be taken twice a day during rifampicin-containing TB treatment and 2 weeks after stopping TB treatment, thereafter the BIC/FTC/TAF single tablet co-formulation will be taken once daily.
|
DTG Arm
n=42 Participants
Dolutegravir 50mg /Lamivudine 300mg/ Tenofovir 300mg (TLD- fixed-drug combination single tablet) plus Dolutegravir 50mg evening dose during TB treatment and for two weeks after completion of TB treatment, then TLD once daily thereafter- as per Standard of Care (SOC)
|
|---|---|---|
|
Number of Participants With Viral Suppression at Week 24
Efficacy in PWH & TB through Week 24 ITT population
|
75 Participants
|
40 Participants
|
|
Number of Participants With Viral Suppression at Week 24
Treatment failure
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 12 and 48To characterize viral suppression rates at weeks 12, 24 and 48 in the standard of care treatment (SOC) arm (currently, TDF 300mg/3TC 300mg/DTG 50mg) and at weeks 12 and 48 in the BIC/FTC/TAF arm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 4, 8, 12, 24,32 and 40To assess BIC drug levels (AUC) when given twice daily and co-administered with Rifampicin vs. during TB treatment vs when given alone after TB treatment completion
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 4, 8, 12, 24, 32 and 40To assess BIC drug levels (Cmax) when given twice daily and co-administered with Rifampicin vs. during TB treatment vs when given alone after TB treatment completion
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 4, 8 12, 24, 32 and 40To assess BIC drug levels ( Ctrough) when given twice daily and co-administered with Rifampicin vs. during TB treatment vs when given alone after TB treatment completion
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through week 24To assess the incidence of TB associated IRIS in each arm
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through week 48To characterize the tolerability of treatment in each arm by assessing frequency of clinician-initiated treatment interruptions or switches through week 48
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24 and 48.To assess frequency of ART drug resistance mutations in participants with detectable viral load at weeks 24 and 48
Outcome measures
Outcome data not reported
Adverse Events
BIC Arm
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
DTG Arm
Serious events: 3 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
BIC Arm
n=80 participants at risk
The Intervention Arm ART regimen is a fixed-drug combination of a single tablet co-formulated regimen containing Bictegravir 50mg Emtricitabine 200mg and tenofovir alafenamide 25mg (BIC/FTC/TAF; Biktarvy®) that will be taken twice a day during rifampicin-containing TB treatment and 2 weeks after stopping TB treatment, thereafter the BIC/FTC/TAF single tablet co-formulation will be taken once daily.
|
DTG Arm
n=42 participants at risk
Dolutegravir 50mg /Lamivudine 300mg/ Tenofovir 300mg (TLD- fixed-drug combination single tablet) plus Dolutegravir 50mg evening dose during TB treatment and for two weeks after completion of TB treatment, then TLD once daily thereafter- as per Standard of Care (SOC)
|
|---|---|---|
|
General disorders
Death
|
0.00%
0/80 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
2.4%
1/42 • Number of events 1 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.5%
2/80 • Number of events 2 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
0.00%
0/42 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
|
Gastrointestinal disorders
Gastritis
|
1.2%
1/80 • Number of events 1 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
0.00%
0/42 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
|
Infections and infestations
Shortness of breath
|
1.2%
1/80 • Number of events 1 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
0.00%
0/42 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
|
Cardiac disorders
Cardiac failure investigations
|
1.2%
1/80 • Number of events 1 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
0.00%
0/42 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
|
Infections and infestations
Left facial weakness and unsteady gait
|
1.2%
1/80 • Number of events 1 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
0.00%
0/42 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
|
Infections and infestations
Invasive fungal disease of ear. Chronic lung disease
|
1.2%
1/80 • Number of events 1 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
0.00%
0/42 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
|
Psychiatric disorders
Attempted suicide
|
1.2%
1/80 • Number of events 1 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
0.00%
0/42 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
|
Blood and lymphatic system disorders
Severe anaemia and renal impairment
|
1.2%
1/80 • Number of events 1 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
0.00%
0/42 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
|
Nervous system disorders
Investigation of left-sided weakness
|
1.2%
1/80 • Number of events 1 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
0.00%
0/42 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
|
Infections and infestations
Possible septic right hip (possible IRIS TB or infective aetiology)
|
1.2%
1/80 • Number of events 1 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
0.00%
0/42 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
|
Investigations
Elevated conjugated hyperbilirubinemia
|
1.2%
1/80 • Number of events 1 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
0.00%
0/42 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
|
Infections and infestations
Underlying lung pathology with left upper zone nodules post completion of TB treatment#
|
1.2%
1/80 • Number of events 1 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
0.00%
0/42 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
|
Nervous system disorders
New onset generalized tonic-clonic seizures
|
1.2%
1/80 • Number of events 1 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
0.00%
0/42 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
|
Injury, poisoning and procedural complications
Motor Vehicle Accident
|
1.2%
1/80 • Number of events 1 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
0.00%
0/42 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/80 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
2.4%
1/42 • Number of events 1 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
|
Vascular disorders
Left lower leg cellulitis
|
0.00%
0/80 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
2.4%
1/42 • Number of events 1 • From enrollment until end of follow-up, up to 48 weeks
Adverse events defined as DAIDS Toxicity Table
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place