HIV/AIDSPhase 2INSIGHTNCT04734652

INSTI's For The Management of HIV-associated TB

A Phase 2 study testing Biktarvy® and TLD- fixed-drug combination single tablet in people with HIV/AIDS and Tuberculosis, Pulmonary, run by Centre for the AIDS Programme of Research in South Africa at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study is being conducted to assess the antiretroviral activity of a fixed-drug, single tablet, combination of Bictegravir 50mg/ Emtricitabine 200mg/ Tenofovir alafenamide 25mg (Biktarvy®) dosed twice daily in HIV-1 infected, ART-naïve patients with TB co-infection receiving a rifampicin-based tuberculosis (TB)… Read more about this study

Who is it for?: Ages 18 to 105 years
Conditions the study is for: HIV/AIDS, Tuberculosis, Pulmonary
What is being tested?: Biktarvy® and TLD- fixed-drug combination single tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 122 participants
Where: 1 siteSouth Africa
Study dates: 18 Feb 2022to 31 Aug 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 105 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults ≥ 18 years of age with Karnofsky score ≥ 70
Confirmed rifampicin-susceptible tuberculosis and/or
On first-line rifampicin-based tuberculosis treatment (not > 8 weeks at the time of enrolment)
Documented HIV-1 infection, ART-naïve OR ART non-naïve (patients to have no exposure to ART medication at least ≥ 3 months at the time of enrollment)
Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m2
Alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN)

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Total bilirubin ≤2.5 times ULN
Creatinine ≤2 times ULN
Hemoglobin ≥ 7.0 g/dL (6.5 g/dL for females)
Platelet count ≥ 50,000/mm3
Absolute Neutrophil Count (ANC) ≥650/mm3
Able and willing to provide written informed consent
Female patients agree to use both a barrier and a non-barrier form of contraception during the study, starting at least 14 days prior to enrolment

Who cannot join

Pregnancy or breastfeeding (or planned pregnancy within 12 months of study entry)
Prior use of antiretroviral drugs for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) < 3 months at the time of enrolment
Hepatitis B surface antigen positive OR Hepatitis B virus (HBV) infection OR active systemic infections (other than HIV-1 infection) requiring systemic antibiotic or antifungal therapy current or within 30 days prior to baseline that could, in the opinion of the investigator, interfere with study procedures or assessment of study outcomes
Participants with a CD4+ cell count of < 50 cells/ μl
Any verified Grade 4 laboratory abnormality, with the exception of, Grade 4 triglycerides. A single repeat test is allowed during the Screening period to verify a result
Patients on metformin (> 500mg, 12hourly)

Show all 9Show fewer

Patients with an uncontrolled psychiatric co-morbidity. Patients who, in the investigator's judgment, pose a significant suicidality risk. Recent history of suicidal behavior and/or suicidal ideation may be considered as evidence of serious suicide risk
Other condition or circumstance deemed by clinician/investigators to be detrimental to patient safety or study conduct
Unwilling to be part of the main pharmacokinetic (PK) study and have PK blood draws done (NB there is a semi-intensive PK substudy which is optional)

Trial locations and contacts

1 site in 1 country.

South Africa1 site

CAPRISA Springfield Clinical Research Site
Durban, KwaZulu-Natal, 4001

Other trials in South Africa

About this study

Official title: A Phase 2b Study to Evaluate the Efficacy, Safety and PK of a Combination of Bictegravir, Emtricitabine, and Tenofovir Alafenamide Fumarate for Treatment of HIV-1 Infection in Patients With Drug Susceptible-TB on a Rifampicin-based Regimen

Read the detailed description

Primary objective: To characterize viral suppression rates (proportion of patients with suppressed viral load) at week 24 in the BIC arm

Secondary objectives:

To 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.

To compare the pharmacokinetics (PK) of BIC when given twice daily and co-administered with Rifampicin during tuberculosis treatment vs when given alone after discontinuation of Rifampicin

To assess the incidence of TB associated IRIS in each arm, through week 24.

To characterize the tolerability of treatment in each arm by assessing frequency of clinician-initiated treatment interruptions or switches through week 48.

To assess frequency of ART drug resistance mutations in participants with detectable viral load at study visit weeks 24 and 48.

Conditions: HIV/AIDS, Tuberculosis, Pulmonary
Being tested: Biktarvy®, TLD- fixed-drug combination single tablet
Keywords: Biktarvy® is a fixed dose combination, TLD- fixed-drug combination single tablet, Dolutegravir 50mg, HIV/AIDS, Tuberculosis, Pulmonary
Medical subject headings: Acquired Immunodeficiency Syndrome, Tuberculosis, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Biktarvy®Combination product
Biktarvy® is a fixed dose combination, single tablet containing bictegravir (BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF) for oral administration.
BIC is an integrase strand transfer inhibitor (INSTI). FTC, a synthetic nucleoside analog of cytidine, is an HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI). TAF, an HIV NRTI, is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Each tablet contains 50 mg of BIC (equivalent to 52.5 mg of bictegravir sodium), 200 mg of FTC, and 25 mg of TAF (equivalent to 28 mg of tenofovir alafenamide fumarate) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.
TLD- fixed-drug combination single tabletCombination product
Also called Dolutegravir 50mg /Lamivudine 300mg/ Tenofovir 300mg
Standard of care Dolutegravir-based regimen

Study groups in NCT04734652
Study group	Role	What they receive
BIC arm	Experimental	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. Receives: Combination Product: Biktarvy®
DTG Arm	Active comparator	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) Receives: Combination Product: TLD- fixed-drug combination single tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Viral Suppression at Week 24
Viral suppression rate (HIV-1 RNA <50 copies/mL) at week 24 in the BIC arm (using the FDA snapshot algorithm).
Measured: Week 24

Secondary outcomes (7)

Viral Suppression Rates (HIV-1 RNA <50 Copies/mL) at Weeks 12, 24 and 48 in the DTG Arm and at 12 and 48 Weeks in the BIC Arm
To 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.
Measured: Week 12 and 48
BIC Drug Concentrations ("Area Under the Plasma Concentration Versus Time Curve (AUC)"
To 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
Measured: Week 4, 8, 12, 24,32 and 40
BIC Drug Concentrations [Peak Plasma Concentration (Cmax)]
To 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
Measured: Week 4, 8, 12, 24, 32 and 40
BIC Drug Concentrations [Trough/Minimum Plasma Concentration Ctrough)
To 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
Measured: Week 4, 8 12, 24, 32 and 40
The Incidence of TB Associated IRIS
To assess the incidence of TB associated IRIS in each arm
Measured: Through week 24
The Tolerability of Treatment in Each Arm
To characterize the tolerability of treatment in each arm by assessing frequency of clinician-initiated treatment interruptions or switches through week 48
Measured: Through week 48
Frequency of ART Drug Resistance Mutations in Participants With Detectable Viral Load at Weeks 24 and 48
To assess frequency of ART drug resistance mutations in participants with detectable viral load at weeks 24 and 48
Measured: Week 24 and 48.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Feb 202231 Aug 2024

First posted2 Feb 2021
Study start18 Feb 2022
Primary completion19 Jan 2024
Study completion31 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for HIV/AIDSStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 80 participants for the Intervention Arm ART regimen which 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. 40 participants in the Control 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)
Masking: None (open label)
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04734652
Sponsor's protocol ID: CAPRISA 093
Other IDs: 1R01AI152142-01
Acronym: INSIGHT
Status last verified: Sep 2025
First submitted: 11 Jan 2021
Last updated: 3 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data generated under this project will be shared in accordance with CAPRISA, and NIH-SAMRC policies, including the NIH Data Sharing Policy. Research data that documents, supports, and validates research findings will be made available after the main findings from the final research data set have been accepted for publication.

Publications

Osuala EC, Nkuhairwe IN, Letsoalo MP, Naidoo K, Perumal R, Rooney JF, Wiesner L, Wasmann RE, Denti P, Dooley KE, Naidoo A; INSIGHT Study Team. Pharmacokinetics of Twice-daily Tenofovir Alafenamide in Adults With HIV-associated Tuberculosis on Bictegravir/Emtricitabine/Tenofovir Alafenamide and Rifampicin. Clin Infect Dis. 2026 Apr 30;82(4):e720-e727. doi: 10.1093/cid/ciaf732.
PubMed 41467354
Naidoo A, Naidoo K, Letsoalo MP, Wasmann RE, Dorse G, Perumal R, Moosa MS, Osuala EC, Boodhram R, Chimukangara B, Wiesner L, Israelski D, Denti P, Rooney JF, Dooley KE; INSIGHT Study Team. Fixed-dose combination bictegravir-emtricitabine-tenofovir alafenamide twice-daily for treatment of HIV during rifampicin-based tuberculosis treatment (INSIGHT Study): a phase 2b, open-label, randomised non-comparative trial. Lancet HIV. 2026 Jan;13(1):e9-e20. doi: 10.1016/S2352-3018(25)00200-0. Epub 2025 Dec 1.
PubMed 41344350
Naidoo A, Dooley KE, Naidoo K, Padayatchi N, Yende-Zuma N, Perumal R, Dorse G, Boodhram R, Osuala EC. INSTIs for the management of HIV-associated TB (INSIGHT study): a phase 2b study to evaluate the efficacy, safety and pharmacokinetics of a combination of bictegravir, emtricitabine and tenofovir alafenamide fumarate for the treatment of HIV-1 infection in patients with drug-susceptible tuberculosis on a rifampicin-based treatment regimen: a phase 2b open-label randomised controlled trial. BMJ Open. 2022 Nov 10;12(11):e067765. doi: 10.1136/bmjopen-2022-067765.
PubMed 36356989

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2b Study to Evaluate the Efficacy, Safety and PK of a Combination of Bictegravir, Emtricitabine, and Tenofovir Alafenamide Fumarate for Treatment of HIV-1 Infection in Patients With Drug Susceptible-TB on a Rifampicin-based Regimen
ClinicalTrials.gov ID: NCT04734652
Acronym / sponsor ID: INSIGHT / CAPRISA 093
Conditions: HIV/AIDS, Tuberculosis, Pulmonary
Keywords: Biktarvy® is a fixed dose combination, TLD- fixed-drug combination single tablet, Dolutegravir 50mg, HIV/AIDS, Tuberculosis, Pulmonary
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: Centre for the AIDS Programme of Research in South AfricaResearch network
Collaborators: Johns Hopkins University, National Institute of Allergy and Infectious Diseases (NIAID), University of Cape Town, Medical Research Council, South Africa
Study start: 18 Feb 2022 (actual)
Primary completion: 19 Jan 2024 (actual)
Study completion: 31 Aug 2024 (actual)
First posted: 2 Feb 2021 (actual)
Results: Posted 15 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Primary objective: To characterize viral suppression rates (proportion of patients with suppressed viral load) at week 24 in the BIC arm

Secondary objectives:

To 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.

To compare the pharmacokinetics (PK) of BIC when given twice daily and co-administered with Rifampicin during tuberculosis treatment vs when given alone after discontinuation of Rifampicin

To assess the incidence of TB associated IRIS in each arm, through week 24.

To characterize the tolerability of treatment in each arm by assessing frequency of clinician-initiated treatment interruptions or switches through week 48.

To assess frequency of ART drug resistance mutations in participants with detectable viral load at study visit weeks 24 and 48.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 80 participants for the Intervention Arm ART regimen which 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. 40 participants in the Control 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)

Arm	Type	Receives
BIC arm	Experimental	Combination Product: Biktarvy®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	Active comparator	Combination Product: TLD- fixed-drug combination single tabletDolutegravir 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)

Who may qualify

Ages: 18 to 105 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Adults ≥ 18 years of age with Karnofsky score ≥ 70
Confirmed rifampicin-susceptible tuberculosis and/or
On first-line rifampicin-based tuberculosis treatment (not > 8 weeks at the time of enrolment)
Documented HIV-1 infection, ART-naïve OR ART non-naïve (patients to have no exposure to ART medication at least ≥ 3 months at the time of enrollment)
Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m2

Key exclusion criteria (9 listed)

Pregnancy or breastfeeding (or planned pregnancy within 12 months of study entry)
Prior use of antiretroviral drugs for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) < 3 months at the time of enrolment
Hepatitis B surface antigen positive OR Hepatitis B virus (HBV) infection OR active systemic infections (other than HIV-1 infection) requiring systemic antibiotic or antifungal therapy current or within 30 days prior to baseline that could, in the opinion of the investigator, interfere with study procedures or assessment of study outcomes
Participants with a CD4+ cell count of < 50 cells/ μl
Any verified Grade 4 laboratory abnormality, with the exception of, Grade 4 triglycerides. A single repeat test is allowed during the Screening period to verify a result

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Biktarvy®Biktarvy® is a fixed dose combination, single tablet containing bictegravir (BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF) for oral administration. BIC is an integrase strand transfer inhibitor (INSTI). FTC, a synthetic nucleoside analog of cytidine, is an HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI). TAF, an HIV NRTI, is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Each tablet contains 50 mg of BIC (equivalent to 52.5 mg of bictegravir sodium), 200 mg of FTC, and 25 mg of TAF (equivalent to 28 mg of tenofovir alafenamide fumarate) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.	Combination product	BIC arm
TLD- fixed-drug combination single tabletAlso: Dolutegravir 50mg /Lamivudine 300mg/ Tenofovir 300mgStandard of care Dolutegravir-based regimen	Combination product	DTG Arm

Primary outcome

Number of Participants With Viral Suppression at Week 24
Time frame: Week 24
Viral suppression rate (HIV-1 RNA <50 copies/mL) at week 24 in the BIC arm (using the FDA snapshot algorithm).

7 secondary outcomes

Viral Suppression Rates (HIV-1 RNA <50 Copies/mL) at Weeks 12, 24 and 48 in the DTG Arm and at 12 and 48 Weeks in the BIC Arm
Time frame: Week 12 and 48
BIC Drug Concentrations ("Area Under the Plasma Concentration Versus Time Curve (AUC)"
Time frame: Week 4, 8, 12, 24,32 and 40
BIC Drug Concentrations [Peak Plasma Concentration (Cmax)]
Time frame: Week 4, 8, 12, 24, 32 and 40
BIC Drug Concentrations [Trough/Minimum Plasma Concentration Ctrough)
Time frame: Week 4, 8 12, 24, 32 and 40
The Incidence of TB Associated IRIS
Time frame: Through week 24
The Tolerability of Treatment in Each Arm
Time frame: Through week 48
Frequency of ART Drug Resistance Mutations in Participants With Detectable Viral Load at Weeks 24 and 48
Time frame: Week 24 and 48.

Results and safety

Results posted to the registry on 15 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BIC Arm	80	78
DTG Arm	42	41

Primary outcome: Number of Participants With Viral Suppression at Week 24

Time frame: Week 24. Count of participants. Unit: Participants

Measure	BIC Arm n = 80	DTG Arm n = 42
Efficacy in PWH & TB through Week 24 ITT population	75	40
Treatment failure	0	0

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until end of follow-up, up to 48 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BIC Arm	11 of 80 (13.8%)	0 of 80 (0%)	0 of 80
DTG Arm	3 of 42 (7.1%)	0 of 42 (0%)	1 of 42

Limitations and caveats (from the sponsor): Non-comparative design

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41467354Osuala EC, Nkuhairwe IN, Letsoalo MP, Naidoo K, Perumal R, Rooney JF, Wiesner L, Wasmann RE, Denti P, Dooley KE, Naidoo A; INSIGHT Study Team. Pharmacokinetics of Twice-daily Tenofovir Alafenamide in Adults With HIV-associated Tuberculosis on Bictegravir/Emtricitabine/Tenofovir Alafenamide and Rifampicin. Clin Infect Dis. 2026 Apr 30;82(4):e720-e727. doi: 10.1093/cid/ciaf732.
Derived from this study: PubMed 41344350Naidoo A, Naidoo K, Letsoalo MP, Wasmann RE, Dorse G, Perumal R, Moosa MS, Osuala EC, Boodhram R, Chimukangara B, Wiesner L, Israelski D, Denti P, Rooney JF, Dooley KE; INSIGHT Study Team. Fixed-dose combination bictegravir-emtricitabine-tenofovir alafenamide twice-daily for treatment of HIV during rifampicin-based tuberculosis treatment (INSIGHT Study): a phase 2b, open-label, randomised non-comparative trial. Lancet HIV. 2026 Jan;13(1):e9-e20. doi: 10.1016/S2352-3018(25)00200-0. Epub 2025 Dec 1.
Derived from this study: PubMed 36356989Naidoo A, Dooley KE, Naidoo K, Padayatchi N, Yende-Zuma N, Perumal R, Dorse G, Boodhram R, Osuala EC. INSTIs for the management of HIV-associated TB (INSIGHT study): a phase 2b study to evaluate the efficacy, safety and pharmacokinetics of a combination of bictegravir, emtricitabine and tenofovir alafenamide fumarate for the treatment of HIV-1 infection in patients with drug-susceptible tuberculosis on a rifampicin-based treatment regimen: a phase 2b open-label randomised controlled trial. BMJ Open. 2022 Nov 10;12(11):e067765. doi: 10.1136/bmjopen-2022-067765.
Individual participant dataSharing planned: Yes. Data generated under this project will be shared in accordance with CAPRISA, and NIH-SAMRC policies, including the NIH Data Sharing Policy. Research data that documents, supports, and validates research findings will be made available after the main findings from the final research data set have been accepted for publication.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anushka Naidoo, PhD principal investigator

Centre for the AIDS Programme of Research in South Africa (CAPRISA)

Kelly Dooley, MD principal investigator

Vanderbilt University Medical Center

Kogieleum Naidoo, PhD study director

Centre for the AIDS Programme of Research in South Africa

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Viral Suppression at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04734652, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.