HIV-1-infectionPhase 4NCT04040075
Testing the Safety and Efficacy of Commercial Drug Biktarvy in Subjects Known to Have the 184 Resistance Mutation to a Component in Biktarvy
A Phase 4 study testing Biktarvy Tab in people with HIV-1-infection, run by Southampton Healthcare, Inc. at 1 site in United States.
Trial summary
An Open-Label Study to Evaluate Switching from a Regimen of Elvitegravir/Tenofovir alafenamide/Emtricitabine/Cobicistat and Darunavir, to a Fixed-Dose Combination of Bictegravir/Tenofovir alafenamide/Emtricitabine in Virologically Suppressed HIV-1 Subjects who are known to have a I84 V/I Mutation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Biktarvy Tab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 8 Jul 2022
- Phase
- Phase 4
- 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
- The ability to understand and sign a written informed consent which must be obtained prior to initiation of study procedures.
- Age equal to or greater than 18 years.
- Currently receiving an ARV regimen of EVG/F/TAF +DRV greater than six month.
- Documented plasma HIV - 1 RNA less than 50 copies/ml during the treatment with Elvitegravir/F/TAF for a minimum of 12 months prior to screening, on two separate determinations, with one determination within 3 months prior to screening.
- Have a documented 184 V/I resistant mutation.
- HIV-1 RNA levels < 50 copies per ml at screening.
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- Estimated GFR >than or equal to 30 mls/min.
- AST and ALT equal to or less than 5 times upper limit of normal.
- Total bilirubin less than or equal to 1.5 mg/dl or normal direct bilirubin.
- Adequate hematologic function (absolute neutrophil count equal to or greater than 750/mm to the third, platelets equal to or greater than 50,000/mm to the third, Hemoglobin equal to or greater than 8.5 g/dl).
- Persons of child bearing potential must have negative serum pregnancy test at screening.
- Male participants and persons of child bearing potential who engage in heterosexual intercourse must agree to use our protocol specified methods of contraception.
- Female participants must agree to refrain from egg donation from first dose of FDC of B/F/TAF and throughout the study.
- Male participants must agree to refrain from sperm donation from first dose until at least 30 days after last dose of drug.
- Life expectancy equal to or greater than one year.
Who cannot join
- No desire to switch from current antiretroviral treatment.
- Any previous use of B/F/TAF.
- Any opportunistic illness indicative of stage 3 HIV diagnosed within 30 days prior to screening.
- Malignancy within 5 years of screening other than cutaneous Kaposi's sarcoma, completed resected non melanoma skin cancer, basal cell carcinoma, or noninvasive cutaneous squamous carcinoma, or completed resected carcinoma in situ of the cervix or anus. A prior malignancy treated with curative therapy and for which there has been no evidence of disease for at least 5 years prior to screening.
- Known hypersensitivity to FDC of B/F/TAF tablets their metabolites or formulation.
- No active treatment of Hepatitis C during the 48 weeks of the study.
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- Females who are pregnant confirmed by serum pregnancy test.
- Females who are breast feeding.
- Suspected Biktarvy resistance mutations, except 184 V/I.
- Patients who need to take Dofetilide, Rifampin, Rifapentine, Rifabutin, phenobarbital, phenytoin, carbamazepine, oxcarbazepine, and antiretrovirals not part of the study and St. John's Wart during.
- Acute Hepatitis in the 30 days prior to screening.
- Active tuberculosis infection.
- Current alcohol or substance use judged by the investigator to potentially interfere with subject study compliance.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southampton Healthcare, Inc.
St Louis, Missouri, 63139
About this study
Official title: Open-label Switch Study From a Regimen of Elvitegravir/Tenofovir Alafenamide/Emtricitabine/Cobicistat and Darunavir, to a FDC of Bictegravir/Tenofovir Alafenamide/Emtricitabine in Virologically Suppressed HIV-l Subjects Known to Have an 184 V/I Mutation
An Open-Label Study to Evaluate Switching from a Regimen of Elvitegravir/Tenofovir alafenamide/Emtricitabine/Cobicistat and Darunavir, to a Fixed-Dose Combination of Bictegravir/Tenofovir alafenamide/Emtricitabine in Virologically Suppressed HIV-1 Subjects who are known to have a I84 V/I Mutation
Read the detailed description
An Open-Label Study to Evaluate Switching from a Regimen of Elvitegravir/Tenofovir alafenamide/Emtricitabine/Cobicistat and Darunavir, to a Fixed-Dose Combination of Bictegravir/Tenofovir alafenamide/Emtricitabine in Virologically Suppressed HIV-1 Subjects who are known to have a I84 V/I Mutation
- Conditions
- HIV-1-infection
- Being tested
- Biktarvy Tab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biktarvy TabDrug
Antiretroviral drug
| Study group | Role | What they receive |
|---|---|---|
| Open label | Other | Open label Biktarvy to establish suppression of HIV 1 with 184 V/I Resistance Mutation Receives: Drug: Biktarvy Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test the safety and effectiveness of the drug Biktarvy in subjects known to have the 184 V/I resistance mutation.
Pure Virologic Response (PVR) with HIV-1 RNA < 50 copies/mL at week 12.
Measured: In 48 week study
Secondary outcomes (2)
Test the safety and effectiveness of the drug Biktarvy in subjects known to have the 184 V/I resistance mutation.
Pure Virologic Response (PVR) with HIV-1 RNA < 50 copies/mL at week 24.
Measured: In 48 Week study
Test the safety and effectiveness of the drug Biktarvy in subjects known to have the 184
Pure Virologic Response (PVR) with HIV-1 RNA < 50 copies/mL at week 48
Measured: 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start1 Jul 2019
- Primary completion14 Jun 2022
- Study completion8 Jul 2022
Why it stopped: Unable to complete enrollment goals due to unanticipated factors of screen failures, covid pandemic, and continued staffing and enrollment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- subjects under current treatment for HIV with the I84 I/V Mutation Resistance
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southampton Healthcare, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040075
- Sponsor's protocol ID
- 184 Resistance Study
- Status last verified
- Jan 2023
- First submitted
- 11 Jul 2019
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Switch Study From a Regimen of Elvitegravir/Tenofovir Alafenamide/Emtricitabine/Cobicistat and Darunavir, to a FDC of Bictegravir/Tenofovir Alafenamide/Emtricitabine in Virologically Suppressed HIV-l Subjects Known to Have an 184 V/I Mutation
- ClinicalTrials.gov ID
- NCT04040075
- Acronym / sponsor ID
- 184 Resistance Study
- Conditions
- HIV-1-infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to complete enrollment goals due to unanticipated factors of screen failures, covid pandemic, and continued staffing and enrollment difficulties
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Southampton Healthcare, Inc.University, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 14 Jun 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 31 Jul 2019 (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.
An Open-Label Study to Evaluate Switching from a Regimen of Elvitegravir/Tenofovir alafenamide/Emtricitabine/Cobicistat and Darunavir, to a Fixed-Dose Combination of Bictegravir/Tenofovir alafenamide/Emtricitabine in Virologically Suppressed HIV-1 Subjects who are known to have a I84 V/I Mutation
Detailed description
An Open-Label Study to Evaluate Switching from a Regimen of Elvitegravir/Tenofovir alafenamide/Emtricitabine/Cobicistat and Darunavir, to a Fixed-Dose Combination of Bictegravir/Tenofovir alafenamide/Emtricitabine in Virologically Suppressed HIV-1 Subjects who are known to have a I84 V/I Mutation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- subjects under current treatment for HIV with the I84 I/V Mutation Resistance
| Arm | Type | Receives |
|---|---|---|
| Open label | Other | Drug: Biktarvy TabOpen label Biktarvy to establish suppression of HIV 1 with 184 V/I Resistance Mutation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- The ability to understand and sign a written informed consent which must be obtained prior to initiation of study procedures.
- Age equal to or greater than 18 years.
- Currently receiving an ARV regimen of EVG/F/TAF +DRV greater than six month.
- Documented plasma HIV - 1 RNA less than 50 copies/ml during the treatment with Elvitegravir/F/TAF for a minimum of 12 months prior to screening, on two separate determinations, with one determination within 3 months prior to screening.
- Have a documented 184 V/I resistant mutation.
Key exclusion criteria (13 listed)
- No desire to switch from current antiretroviral treatment.
- Any previous use of B/F/TAF.
- Any opportunistic illness indicative of stage 3 HIV diagnosed within 30 days prior to screening.
- Malignancy within 5 years of screening other than cutaneous Kaposi's sarcoma, completed resected non melanoma skin cancer, basal cell carcinoma, or noninvasive cutaneous squamous carcinoma, or completed resected carcinoma in situ of the cervix or anus. A prior malignancy treated with curative therapy and for which there has been no evidence of disease for at least 5 years prior to screening.
- Known hypersensitivity to FDC of B/F/TAF tablets their metabolites or formulation.
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 TabAntiretroviral drug | Drug | Open label |
Primary outcome
Test the safety and effectiveness of the drug Biktarvy in subjects known to have the 184 V/I resistance mutation.
Time frame: In 48 week study
Pure Virologic Response (PVR) with HIV-1 RNA < 50 copies/mL at week 12.
2 secondary outcomes
Test the safety and effectiveness of the drug Biktarvy in subjects known to have the 184 V/I resistance mutation.
Time frame: In 48 Week study
Test the safety and effectiveness of the drug Biktarvy in subjects known to have the 184
Time frame: 48 Weeks
Results and safety
The study was stopped early (reason given: Unable to complete enrollment goals due to unanticipated factors of screen failures, covid pandemic, and continued staffing and enrollment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Biktarvy Tab in people with HIV-1-infection, run by Southampton Healthcare, Inc. at 1 site in United States.
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 15 inclusion and 13 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: stopped early, as of the sponsor's last update on 5 Jan 2023. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Unable to complete enrollment goals due to unanticipated factors of screen failures, covid pandemic, and continued staffing and enrollment difficulties). Results are not available in the source record.
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?
Test the safety and effectiveness of the drug Biktarvy in subjects known to have the 184 V/I resistance mutation. (time frame: In 48 week study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2023.