HIV-1-infectionPhase 1EpiTAFNCT04424264

The Effect of Rifampicin on the Pharmacokinetics of Intracellular Tenofovir-diphosphate and Tenofovir When Coadministered With Tenofovir Alafenamide Fumarate During the Maintenance Phase of Tuberculosis Treatment in TB/HIV-1 Coinfected Participants

A Phase 1 study testing Phase 1: Tenofovir disoproxil fumarate/Emtricitabine/Efavirenz coadministered with Rifampicin/Isoniazid, Phase 2: Tenofovir alafenamide/Lamivudine/Efavirenz coadministered with Rifampicin/Isoniazid and Phase 3: Tenofovir disoproxil fumarate/Emtricitabine/Efavirenz in people with HIV-1-infection and Tuberculosis, run by Professor Francois Venter at 2 sites in South Africa.

Completed

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

Official record

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Trial summary

This is a pharmacokinetic study investigating the effect of rifampicin on the pharmacokinetics of intracellular tenofovir-diphosphate and plasma tenofovir when coadministered with tenofovir alafenamide fumarate during the maintenance phase of tuberculosis treatment in TB/HIV-1 coinfected participants (EpiTAF) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV-1-infection, Tuberculosis
What is being tested?: Phase 1: Tenofovir disoproxil fumarate/Emtricitabine/Efavirenz coadministered with Rifampicin/Isoniazid, Phase 2: Tenofovir alafenamide/Lamivudine/Efavirenz coadministered with Rifampicin/Isoniazid and Phase 3: Tenofovir disoproxil fumarate/Emtricitabine/Efavirenz
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 2 sitesSouth Africa
Study dates: 5 Dec 2019to 30 Oct 2020
Phase: Phase 1
Are there results?: None posted in the registry

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult (≥ 18 years old) male or female
HIV-1 infected on TDF/FTC/EFV with HIV RNA < 50 copies/mL in the last three months
On TB treatment in the maintenance phase (RIF/INH) with at least one month of TB treatment needed for completion
Women of childbearing potential must not be pregnant or breastfeeding, with a negative pregnancy test at screening
Women must be postmenopausal, surgically sterile or practicing an effective birth control method (established before and maintained throughout the trial). Women who are not sexually active must agree to use an effective birth control method if they become heterosexually active during the trial
Understand the purpose of and procedures required for the study and having confirmed they are willing to participate in the study by signing the informed consent document.

Who cannot join

Weight < 40 kg
Estimated creatinine clearance < 50 mL/min
Any active clinically significant or life-threatening disease (e.g. acute infections, pancreatitis, hepatitis, cardiac dysfunction), medical or psychiatric condition, or findings during screening, that in the investigator's opinion would compromise the safety of the participant or the study outcome, or their ability to comply with the study procedures
Chronic medical requirement for any drugs that are known to affect the PK of the study drugs
Active drug/alcohol abuser
History of allergy or hypersensivity to any of the study drugs
Currently enrolled in an investigational drug study or has participated in an investigational drug study within the 4 weeks before screening
Unable to comply with study protocol and study protocol restrictions

Trial locations and contacts

2 sites in 1 country.

South Africa2 sites

Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng, 2196
Wits RHI Yeoville Clinic
Johannesburg, Gauteng

Other trials in South Africa

About this study

Read the detailed description

This is an open-label, sequential, single centre pharmacokinetic (PK) study investigating the effect of rifampicin on the pharmacokinetics of intracellular tenofovir-diphosphate and plasma tenofovir when coadministered with tenofovir alafenamide fumarate during the maintenance phase of tuberculosis treatment in TB/HIV-1 coinfected participants (EpiTAF).

An open-label, sequential, pharmacokinetic (PK) drug-drug interaction study will be conducted in medically stable virologically suppressed HIV-1 infected adults coinfected with TB, who are in the maintenance phase of their TB treatment. After intensive PK evaluation of IC TFV-DP and pTFV, participants will be switched from their standard-of-care tenofovir disoproxil fumarate (TDF)/FTC/EFV regimen, to TAF + 3TC + EFV at the start of the study treatment period. After 28 days each participant will have intensive PK evaluation of IC TFV-DP and pTFV on TAF + 3TC + EFV with rifampicin (RIF). After the second intensive PK assessment is completed, participants will be switched back to TDF/FTC/EFV, with a final intensive PK evaluation of IC TFV-DP and pTFV 8 days after completion of TB treatment, at the final study visit. Eighteen volunteers will be enrolled for a target of 13 participants completing the study.

The study includes screening and enrolment visits, 1 visit on day 28 and an end of study visit 28 days after the end of TB treatment.

Conditions: HIV-1-infection, Tuberculosis
Being tested: Phase 1: Tenofovir disoproxil fumarate/Emtricitabine/Efavirenz coadministered with Rifampicin/Isoniazid, Phase 2: Tenofovir alafenamide/Lamivudine/Efavirenz coadministered with Rifampicin/Isoniazid, Phase 3: Tenofovir disoproxil fumarate/Emtricitabine/Efavirenz
Keywords: Rifampicin, RIF/INH, Tenofovir alafenamide fumarate (TAF), Pharmacokinetics, Intracellular tenofovir-diphosphate
Medical subject headings: Tuberculosis

What participants receive

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

Phase 1: Tenofovir disoproxil fumarate/Emtricitabine/Efavirenz coadministered with Rifampicin/IsoniazidDrug
Also called Atripla, Rifinah
TDF/FTC/EFV 300/200/600 mg once daily plus RIF/INH 600*/300 mg daily from screening until enrolment (days -15 to 0)
Phase 2: Tenofovir alafenamide/Lamivudine/Efavirenz coadministered with Rifampicin/IsoniazidDrug
Also called HepBest, Stocrin
TAF 25 mg + 3TC 300 mg + EFV 600 mg once daily plus RIF/INH 600/*300 mg daily (days 1 to ≤ 56)
Phase 3: Tenofovir disoproxil fumarate/Emtricitabine/EfavirenzDrug
Also called Atripla, Rifinah
TDF/FTC/EFV 300/200/600 mg once daily. RIF/INH 600mg <70kg, 750mg >70kg

Study groups in NCT04424264
Study group	Role	What they receive
Tenofovir Alafenamide	Experimental	TAF 25 mg once-daily administered with RIF/INH 600*/300mg Receives: Drug: Phase 1: Tenofovir disoproxil fumarate/Emtricitabine/Efavirenz coadministered with Rifampicin/Isoniazid; Drug: Phase 2: Tenofovir alafenamide/Lamivudine/Efavirenz coadministered with Rifampicin/Isoniazid; Drug: Phase 3: Tenofovir disoproxil fumarate/Emtricitabine/Efavirenz

What is being measured

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

IC TFV-DP concentrations during coadministration of TAF or TDF with RIF/INH in TB/HIV-1 coinfected participants
Intracellular and plasma TFV-DP concentrations measured during coadministration of TAF or TDF with RIF/INH
Measured: 56 days

Secondary outcomes (3)

Maintenance of irological suppression (HIV-1 RNA < 50 copies/mL)
Assessment of maintenance of virological suppression (HIV-1 RNA < 50 copies/mL) while on TAF/RIF
Measured: At screening, day 28, completion of TB and EOS visits
Comparison plasma concentrations of TAF with TDF
Assessment to compare the plasma concentrations of tenofovir of TAF with TDF during coadministration of RIF/INH in TB/HIV-1 coinfected participants
Measured: 56 days
Comparison of IC TFV-DP concentrations of TDF
1. To compare the IC TFV-DP concentrations of TDF with and without coadministration with RIF/INH in TB/HIV-1 coinfected participants
Measured: 56 days

Timeline

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

5 Dec 201930 Oct 2020

First posted9 Jun 2020
Study start5 Dec 2019
Primary completion30 Oct 2020
Study completion30 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV-1-infectionStudies 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04424264
Sponsor's protocol ID: WRHI061
Acronym: EpiTAF
Status last verified: Jun 2022
First submitted: 5 Jun 2020
Last updated: 7 Jun 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Mpofu R, Chandiwana N, Sokhela S, Moorhouse M, Venter F, Anderson PL, Wiesner L, Boffito M, Maartens G, Sinxadi P. The Effect of Rifampicin on the Plasma and Intracellular Pharmacokinetics of Tenofovir Alafenamide Fumarate in HIV-associated Tuberculosis. J Acquir Immune Defic Syndr. 2026 Apr 1;101(4):424-431. doi: 10.1097/QAI.0000000000003810.
PubMed 41328799

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?

See locations

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All HIV-1-infection trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Rifampicin on the Pharmacokinetics of Intracellular Tenofovir-diphosphate and Tenofovir When Coadministered With Tenofovir Alafenamide Fumarate During the Maintenance Phase of Tuberculosis Treatment in TB/HIV-1 Coinfected Participants
ClinicalTrials.gov ID: NCT04424264
Acronym / sponsor ID: EpiTAF / WRHI061
Conditions: HIV-1-infection, Tuberculosis
Keywords: Rifampicin, RIF/INH, Tenofovir alafenamide fumarate (TAF), Pharmacokinetics, Intracellular tenofovir-diphosphate
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Professor Francois VenterUniversity, hospital or other
Collaborators: University of Cape Town
Study start: 5 Dec 2019 (actual)
Primary completion: 30 Oct 2020 (actual)
Study completion: 30 Oct 2020 (actual)
First posted: 9 Jun 2020 (actual)
Results: Not posted in the source record

Clinical summary

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

Detailed description

The study includes screening and enrolment visits, 1 visit on day 28 and an end of study visit 28 days after the end of TB treatment.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Tenofovir Alafenamide	Experimental	Drug: Phase 1: Tenofovir disoproxil fumarate/Emtricitabine/Efavirenz coadministered with Rifampicin/Isoniazid, Drug: Phase 2: Tenofovir alafenamide/Lamivudine/Efavirenz coadministered with Rifampicin/Isoniazid, Drug: Phase 3: Tenofovir disoproxil fumarate/Emtricitabine/EfavirenzTAF 25 mg once-daily administered with RIF/INH 600*/300mg

Who may qualify

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

Key inclusion criteria (6 listed)

Adult (≥ 18 years old) male or female
HIV-1 infected on TDF/FTC/EFV with HIV RNA < 50 copies/mL in the last three months
On TB treatment in the maintenance phase (RIF/INH) with at least one month of TB treatment needed for completion
Women of childbearing potential must not be pregnant or breastfeeding, with a negative pregnancy test at screening
Women must be postmenopausal, surgically sterile or practicing an effective birth control method (established before and maintained throughout the trial). Women who are not sexually active must agree to use an effective birth control method if they become heterosexually active during the trial

Key exclusion criteria (8 listed)

Weight < 40 kg
Estimated creatinine clearance < 50 mL/min
Any active clinically significant or life-threatening disease (e.g. acute infections, pancreatitis, hepatitis, cardiac dysfunction), medical or psychiatric condition, or findings during screening, that in the investigator's opinion would compromise the safety of the participant or the study outcome, or their ability to comply with the study procedures
Chronic medical requirement for any drugs that are known to affect the PK of the study drugs
Active drug/alcohol abuser

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
Phase 1: Tenofovir disoproxil fumarate/Emtricitabine/Efavirenz coadministered with Rifampicin/IsoniazidAlso: Atripla, RifinahTDF/FTC/EFV 300/200/600 mg once daily plus RIF/INH 600*/300 mg daily from screening until enrolment (days -15 to 0)	Drug	Tenofovir Alafenamide
Phase 2: Tenofovir alafenamide/Lamivudine/Efavirenz coadministered with Rifampicin/IsoniazidAlso: HepBest, StocrinTAF 25 mg + 3TC 300 mg + EFV 600 mg once daily plus RIF/INH 600/*300 mg daily (days 1 to ≤ 56)	Drug	Tenofovir Alafenamide
Phase 3: Tenofovir disoproxil fumarate/Emtricitabine/EfavirenzAlso: Atripla, RifinahTDF/FTC/EFV 300/200/600 mg once daily. RIF/INH 600mg <70kg, 750mg >70kg	Drug	Tenofovir Alafenamide

Primary outcome

IC TFV-DP concentrations during coadministration of TAF or TDF with RIF/INH in TB/HIV-1 coinfected participants
Time frame: 56 days
Intracellular and plasma TFV-DP concentrations measured during coadministration of TAF or TDF with RIF/INH

3 secondary outcomes

Maintenance of irological suppression (HIV-1 RNA < 50 copies/mL)
Time frame: At screening, day 28, completion of TB and EOS visits
Comparison plasma concentrations of TAF with TDF
Time frame: 56 days
Comparison of IC TFV-DP concentrations of TDF
Time frame: 56 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
Derived from this study: PubMed 41328799Mpofu R, Chandiwana N, Sokhela S, Moorhouse M, Venter F, Anderson PL, Wiesner L, Boffito M, Maartens G, Sinxadi P. The Effect of Rifampicin on the Plasma and Intracellular Pharmacokinetics of Tenofovir Alafenamide Fumarate in HIV-associated Tuberculosis. J Acquir Immune Defic Syndr. 2026 Apr 1;101(4):424-431. doi: 10.1097/QAI.0000000000003810.

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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.

Simiso Sokhela, MBBCh principal investigator

Ezintsha, a subdivision of Wits Reproductive Health and HIV Institute (Wits RHI)

2 sites 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 6 inclusion and 8 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 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

IC TFV-DP concentrations during coadministration of TAF or TDF with RIF/INH in TB/HIV-1 coinfected participants (time frame: 56 days). 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 NCT04424264, which also lists 1 linked publication.

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 7 Jun 2022; AzTrials last refreshed its copy on 8 Nov 2026.