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HIVPhase 3NCT03727152

Switching From Protease Inhibitor/Ritonavir to Generic Single Tablet Regimen of Tenofovir Alafenamide/Emtricitibine/Dolutegravir

A Phase 3 study testing generic single tablet TAF/FTC/DTG in people with HIV, run by The HIV Netherlands Australia Thailand Research Collaboration at 2 sites in Thailand.

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 phase III, multicenter, open-label, single-arm study of 190 virologically suppressed HIV-infected adults Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV
What is being tested?
generic single tablet TAF/FTC/DTG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
2 sitesThailand
Study dates
1 May 2019to 4 Apr 2023
Phase
Phase 3
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

  • Documented HIV-1 infection
  • Aged ≥18 years old
  • Female participant may be eligible to participate if she:
  • is of non-childbearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea or >=54 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy, or bilateral oophorectomy or, is of child-bearing potential, with a negative pregnancy test at both Screening and week 0 and agrees to use one of the protocol-defined methods of contraception to avoid pregnancy.
  • On current ART for at least 6 months prior to study entry
  • Current ART includes boosted protease inhibitors
Show all 10Show fewer
  • No more than one HIV-1 plasma RNA >50 copies/mL and <200 copies/L (only one 'blip') in the past 6 months with a subsequent HIV-1 plasma RNA <50 copies/mL
  • HIV-1 plasma RNA <50 copies/mL at screening visit
  • No prior or current exposure to integrase strand transfer inhibitor (INSTI)
  • Have signed the informed consent form

Who cannot join

  • Breastfeeding female
  • Pregnancy or positive UPT at screening
  • Calculated creatinine clearance as estimated by Cockcroft-Gault equation (CrCl) <60 mL/min,
  • Alanine aminotransferase (ALT) >2.5 x ULN,
  • Concomitant use of any of the following medications:
  • aluminum and magnesium-containing antacids, proton-pump inhibitors (2) anticonvulsants: carbamazepine, oxcarbamazepine, phenobarbital, phenytoin (3) antimycobacterials: rifabutin, rifampin, rifapentine (4) St. John's wort
  • 6. Alcohol or drug abuse that, in the opinion of the investigator, would interfere with completion of study procedures
  • 7. Any serious illness that, in the opinion of the investigator, would interfere with completion of study procedures

Trial locations and contacts

2 sites in 1 country.

Thailand2 sites

  • HIV-NAT, Thai Red Cross AIDS Research Centre

    Bangkok, 10330

  • Police General Hospital

    Bangkok, 10330

Other trials in Thailand

About this study

Official title: Maintenance of Switching From Protease Inhibitor/Ritonavir to Generic Single Tablet Regimen of Tenofovir Alafenamide/Emtricitibine/Dolutegravir in Virologically Suppressed HIV-infected Adults

This is a phase III, multicenter, open-label, single-arm study of 190 virologically suppressed HIV-infected adults

Read the detailed description

The fundamental principle of regimen switching is to maintain viral suppression without jeopardizing future treatment options. The reasons to consider regimen switching in the viral suppressed population are to simplify the regimen by reducing the pill burden and dosing frequency, to increase the tolerability, reduce the adverse effects as well as long-term toxicities, to prevent drug-to-drug interactions and to avoid the dietary requirements.

Generic TAF/E/D (tenofovir alafenamide 25mg/emtricitabine 200mg/dolutegravir 50 mg), a single-tablet once daily regimen, will be an affordable regimen with the potential characteristics such as reduced pill burden, less drug to drug interaction and toxicities. The generic form (Mylan) is recently received the tentative approval from the U.S. Food and Drug Administration (FDA) under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR). Whether DTG-containing regimen is a better option than protease inhibitors among resource-limited settings during the decisions for second-line treatment options, is needed to be evaluated.

All participants will be switched from their pre-study ART regimen to a single tablet regimen (STR) of TAF/FTC/DTG 25/200/50mg once daily.

Conditions
HIV
Being tested
generic single tablet TAF/FTC/DTG
Keywords
generic TAF/E/D, virologically suppressed HIV-infected adults, pharmacokinetics (PK) parameters of DTG, psychiatric symptoms, metabolic syndrome, ASCVD risk, liver fibrosis
Medical subject headings
Metabolic Syndrome, Liver Cirrhosis

What participants receive

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

  • generic single tablet TAF/FTC/DTGDrug

    HIV-infected adults who are virologically suppressed and on protease inhibitor/ritonavir are switched to generic single tablet regimen of tenofovir alafenamide/emtricitibine/dolutegravir

Study groups in NCT03727152
Study groupRoleWhat they receive
generic single tablet regimen of tenofovir alafenamide/eOtherHIV infected adults currently on protease inhibitor/ritonavir will switch to use generic single tablet regimen of tenofovir alafenamide/emtricitibine/dolutegravir to see if the single tablet can continue to suppress viral replication and be used as a maintenance regimen
Receives: Drug: generic single tablet TAF/FTC/DTG

What is being measured

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

  1. number of subjects with undetectable viral load

    Proportion of participants with plasma HIV-1 RNA <50 copies/mL using Snapshot algorithm at week 48

    Measured: 48 weeks

Secondary outcomes (14)

  1. Proportion of participants without tolerability failure

    Proportion of participants without tolerability failure

    Measured: weeks 24 and weeks 48

  2. Cmax of DTG

    maximum plasma concentration (Cmax) of DTG 50 mg

    Measured: weeks 24 and weeks 48

  3. Tmax of DTG

    time to reach maximal concentration (Tmax) of DTG 50 mg

    Measured: weeks 24 and weeks 48

  4. AUC of DTG

    area under the curve of a plasma concentration versus time profile (AUC) of DTG 50 mg

    Measured: weeks 24 and weeks 48

  5. T1/2 of DTG

    elimination half life (T1/2) of DTG 50 mg

    Measured: weeks 24 and weeks 48

  6. Ke of DTG

    elimination rate constant (Ke) of DTG 50 mg

    Measured: weeks 24 and weeks 48

  7. CL of DTG

    total plasma clearance (CL) of DTG 50 mg

    Measured: weeks 24 and weeks 48

  8. Anxiety at baseline will be compared to level of anxiety at weeks 24 and weeks 48.

    Anxiety at baseline will be compared to anxiety level at weeks 24 and weeks 48. Anxiety will be assessed using Hospital Anxiety and Depression Scale (HADS). There are 7 different items that assess the level of anxiety of the participants based on a four-point grading scale specific for each item assessed (i.e., I feel tense or 'wound up'; 0 = not at all; 1 = from time to time, occasionally; 2 = a lot of the time; 3 = most of the time). If the total score is between 0-7, then this is considered to be normal. If the total score is between 8-10, then this is considered borderline abnormal (borderline case). If the total score is between 11-21, then this is considered abnormal (case).

    Measured: weeks 24 and weeks 48

  9. Depression at baseline will be compared to depression level at weeks 24 and weeks 48.

    Depression at baseline will be compared to depression level at weeks 24 and weeks 48. Depression will be assessed using Hospital Anxiety and Depression Scale (HADS). There are 7 different items that assess the level of depression of the participants based on a four-point grading scale specific for each item assessed (i.e., I still enjoy the things I used to enjoy; 0 = definitely as much; 1 = not quite so much; 2 = only a little; 3 = hardly at all). If the total score is between 0-7, then this is considered to be normal. If the total score is between 8-10, then this is considered borderline abnormal (borderline case). If the total score is between 11-21, then this is considered abnormal (case).

    Measured: weeks 24 and weeks 48

  10. Changes from baseline in fasting lipid profiles

    Changes from baseline in fasting lipid profiles (HDL, LDL, cholesterol, TG)

    Measured: weeks 24 and weeks 48

  11. Changes from baseline in insulin

    Changes from baseline in insulin

    Measured: weeks 24 and weeks 48

  12. Changes from baseline in fasting blood glucose levels

    Changes from baseline in fasting blood glucose levels

    Measured: weeks 24 and weeks 48

  13. Changes from baseline in renal parameters (creatinine, eGFR)

    Changes from baseline in renal parameters (creatinine, eGFR)

    Measured: weeks 24 and weeks 48

  14. Changes from baseline in transient elastography results

    Changes from baseline in transient elastography results

    Measured: weeks 24 and weeks 48

Timeline

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

  1. First posted1 Nov 2018
  2. Study start1 May 2019
  3. Primary completion4 Apr 2023
  4. Study completion4 Apr 2023

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03727152
Sponsor's protocol ID
HIV-NAT 256
Status last verified
Feb 2024
First submitted
26 Oct 2018
Last updated
28 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing generic single tablet TAF/FTC/DTG in people with HIV, run by The HIV Netherlands Australia Thailand Research Collaboration at 2 sites in Thailand.

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 10 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 28 Feb 2024. 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 Thailand. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

number of subjects with undetectable viral load (time frame: 48 weeks). 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 NCT03727152.

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 28 Feb 2024.

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