HIV/AIDSPhase 4B-HASTENCT04249037
Rapid Start vs. Standard Start Antiretroviral Therapy (ART) in HIV
A Phase 4 study testing bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) and Standard initiation of antiretroviral therapy (ART) in people with HIV/AIDS, run by University of Colorado, Denver at 3 sites in United States.
Trial summary
This study plans to learn about whether starting HIV treatment very soon after diagnosis is more beneficial than waiting until entering routine clinical care after diagnosis. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) and Standard initiation of antiretroviral therapy (ART)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Dec 2020to 1 Jul 2023
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Men and women 15 years and older in Colorado and 19 years and older in Nebraska. A waiver of parental consent is planned for individuals 15-17 in accordance with Colorado law which allows minors to consent for treatment for sexually transmitted infections, including HIV.
- Reactive HIV-1 on an approved fourth generation HIV-1 antibody/antigen test within 72 hours
- Any primary language with access to an interpreter by phone is included.
Who cannot join
- Pregnancy or intention to become pregnant in the next two years after enrollment
- Symptomatic acute HIV (with fever, rash, influenza-like symptoms)
- Creatinine clearance <30 mL/min by Cockcroft-Gault equation. (Therapy initiated will be terminated promptly in individuals who are found to have creatinine clearance <30 mL/min)
- Prior history of known HIV diagnosis
- Negative confirmatory HIV differentiation assays (therapy initiated will be terminated in individuals with negative tests and excluded from the primary analysis)
- Allergy to bictegravir, emtricitabine or tenofovir alafenamide
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- Signs or symptoms of opportunistic infection with cryptococcal meningitis, tuberculosis or other infection that requires delay of initiation of antiretroviral therapy (up to the discretion of the site PI)
- Vulnerable populations including prisoners and individuals without decision making capacity
- Concommitant use of medications that are contraindicated with bictegravir, emtricitabine and tenofovir alafenamide including adefovir, carbamazepine, cladribine, dofetilide, fosphenytoin-phenytoin, oxcarbazepine, phenobarbital, primidone, rifampin, rifabutin, rifapentine, St. John's Wort, tipranavir
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
University of Colorado Anschutz
Aurora, Colorado, 80045
University of Nebraska
Omaha, Nebraska, 68198
About this study
Official title: Prospective Pilot Study of the Efficacy, Safety and Tolerability of Bictegravir-Based HIV ART Same-Day Treatment Evaluations (B-HASTE)
This study plans to learn about whether starting HIV treatment very soon after diagnosis is more beneficial than waiting until entering routine clinical care after diagnosis.
Read the detailed description
Randomized two arm, multi-site (three sites), open label pilot study conducted with laboratory evaluation and visits at entry, 4 weeks, 12 weeks, 24 weeks, 48 weeks and 96 weeks with laboratory evaluations and assessment if participants remain engaged in care.
Participants will be randomly assigned with equal probability to one of two arms:
Arm A: Same day antiretroviral therapy (ART) with bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) + new diagnosis package with laboratory evaluations and social work referral.
Arm B: Standard initiation of ART at the discretion of provider + new diagnosis package with laboratory evaluations and social work referral.
- Conditions
- HIV/AIDS
- Being tested
- bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF), Standard initiation of antiretroviral therapy (ART)
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)Drug
Also called Biktarvy
A 30 day supply of Bictegravir 50mg/Emtricitabine 200mg/Tenofovir Alafenamide 25mg will be provided to the rapid start arm.
Standard initiation of antiretroviral therapy (ART)Drug
Also called Standard of Care ART
Standard initiation of ART at the discretion of provider + new diagnosis package with laboratory evaluations and social work referral.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Rapid Start Group | Active comparator | Same day antiretroviral therapy (ART) with bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) + new diagnosis package with laboratory evaluations and social work referral. Receives: Drug: bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) |
| Arm B: Standard Group | Placebo comparator | Standard initiation of ART at the discretion of provider + new diagnosis package with laboratory evaluations and social work referral. Receives: Drug: Standard initiation of antiretroviral therapy (ART) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Suppression
Proportion of participants with viral suppression to <50 copies/mL at 48 weeks by FDA snapshot in the rapid-start ART arm compared to the standard of care arm.
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 posted30 Jan 2020
- Study start15 Dec 2020
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Why it stopped: Insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Hillary Dunlevy, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249037
- Sponsor's protocol ID
- 19-0829
- Acronym
- B-HASTE
- Status last verified
- Nov 2023
- First submitted
- 28 Jan 2020
- Last updated
- 30 Nov 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 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Study of the Efficacy, Safety and Tolerability of Bictegravir-Based HIV ART Same-Day Treatment Evaluations (B-HASTE)
- ClinicalTrials.gov ID
- NCT04249037
- Acronym / sponsor ID
- B-HASTE / 19-0829
- Conditions
- HIV/AIDS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 30 Jan 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.
This study plans to learn about whether starting HIV treatment very soon after diagnosis is more beneficial than waiting until entering routine clinical care after diagnosis.
Detailed description
Randomized two arm, multi-site (three sites), open label pilot study conducted with laboratory evaluation and visits at entry, 4 weeks, 12 weeks, 24 weeks, 48 weeks and 96 weeks with laboratory evaluations and assessment if participants remain engaged in care.
Participants will be randomly assigned with equal probability to one of two arms:
Arm A: Same day antiretroviral therapy (ART) with bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) + new diagnosis package with laboratory evaluations and social work referral.
Arm B: Standard initiation of ART at the discretion of provider + new diagnosis package with laboratory evaluations and social work referral.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Rapid Start Group | Active comparator | Drug: bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)Same day antiretroviral therapy (ART) with bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) + new diagnosis package with laboratory evaluations and social work referral. |
| Arm B: Standard Group | Placebo comparator | Drug: Standard initiation of antiretroviral therapy (ART)Standard initiation of ART at the discretion of provider + new diagnosis package with laboratory evaluations and social work referral. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women 15 years and older in Colorado and 19 years and older in Nebraska. A waiver of parental consent is planned for individuals 15-17 in accordance with Colorado law which allows minors to consent for treatment for sexually transmitted infections, including HIV.
- Reactive HIV-1 on an approved fourth generation HIV-1 antibody/antigen test within 72 hours
- Any primary language with access to an interpreter by phone is included.
Key exclusion criteria (9 listed)
- Pregnancy or intention to become pregnant in the next two years after enrollment
- Symptomatic acute HIV (with fever, rash, influenza-like symptoms)
- Creatinine clearance <30 mL/min by Cockcroft-Gault equation. (Therapy initiated will be terminated promptly in individuals who are found to have creatinine clearance <30 mL/min)
- Prior history of known HIV diagnosis
- Negative confirmatory HIV differentiation assays (therapy initiated will be terminated in individuals with negative tests and excluded from the primary analysis)
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 |
|---|---|---|
| bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)Also: BiktarvyA 30 day supply of Bictegravir 50mg/Emtricitabine 200mg/Tenofovir Alafenamide 25mg will be provided to the rapid start arm. | Drug | Arm A: Rapid Start Group |
| Standard initiation of antiretroviral therapy (ART)Also: Standard of Care ARTStandard initiation of ART at the discretion of provider + new diagnosis package with laboratory evaluations and social work referral. | Drug | Arm B: Standard Group |
Primary outcome
Viral Suppression
Time frame: 48 weeks
Proportion of participants with viral suppression to <50 copies/mL at 48 weeks by FDA snapshot in the rapid-start ART arm compared to the standard of care arm.
Results and safety
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 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.
Hillary Dunlevy, MD principal investigator
University of Colorado, Denver
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) and Standard initiation of antiretroviral therapy (ART) in people with HIV/AIDS, run by University of Colorado, Denver at 3 sites 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 3 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: stopped early, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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: Insufficient enrollment). 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?
Viral Suppression (time frame: 48 weeks). 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 30 Nov 2023.