HIV-1-infectionNCT04311944
Early Fast-Track Versus Standard Care for Persons With HIV Initiating TLD
A study testing Early fast-track care and Standard (deferred fast-track) care in people with HIV-1-infection, run by Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic.
Trial summary
This study will evaluate the clinical efficacy of using earlier fast-track services compared to the standard of care in a clinical setting to improve retention in care and virologic suppression for patients who are initiating a dolutegravir-based antiretroviral therapy regimen. 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?
- Early fast-track care and Standard (deferred fast-track) care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 29 May 2022
- Phase
- Interventional
- 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
- Documentation of positive HIV status (test conducted at GHESKIO)
- Age ≥18 years of age
- Eligible for TLD regimen, according to Haitian Ministry of Health guidelines
- Initiate ART within 3 days prior to enrollment
- Lives in Port-au-Prince metropolitan area
- Ability and willingness to give written informed consent
- Use of reliable contraception (for women of childbearing potential);
- Physician-confirmed WHO Stage 1 or 2 disease
Who cannot join
- Not ART-naïve (history of ART for any duration in the past)
- World Health Organization Stage 3 or 4 disease;
- Pregnancy or breastfeeding at the screening visit;
- Planning to become pregnant during the study period;
- Active drug, alcohol use, or mental condition that would interfere with the ability to adhere to study requirements, in the opinion of the study physician;
- Creatinine clearance (CrCl) <50 within 1 month prior to study entry;
- ALT and/or AST> 5X upper limit of normal (ULN) within 1 month prior to study entry;
- Planning to transfer care to another clinic during the study period
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Early Fast-Track Versus Standard Care for Persons With HIV Initiating Tenofovir Disoproxil Fumarate-Lamivudine-Dolutegravir (TLD) in Haiti: A Pilot Randomized Trial
This study will evaluate the clinical efficacy of using earlier fast-track services compared to the standard of care in a clinical setting to improve retention in care and virologic suppression for patients who are initiating a dolutegravir-based antiretroviral therapy regimen.
Read the detailed description
With current approaches to HIV care, patients generally do not qualify for expedited services until they have been in care for 6 to 12 months. Once they have achieved an undetectable viral load and/or high adherence, patients qualify for expedited services with fewer clinic visits. The problem with this approach is that it's time-intensive early in ART care, when attrition rates are highest. A potential solution to this problem is to provide earlier fast-track care for patients on dolutegravir-based regimens with viral suppression. This strategy is feasible due to the high potency and rapid declines in viral load with dolutegravir-based regimens.
We will compare a strategy of early fast-track care (8 to 12 weeks, for patients with viral suppression) versus standard initiation of fast-track care (after 6 months in care, with viral suppression). All participants will receive the same ART regimen, the combination regimen of Tenofovir Disoproxil Fumarate-Lamivudine-Dolutegravir.
- Conditions
- HIV-1-infection
- Being tested
- Early fast-track care, Standard (deferred fast-track) care
- Keywords
- HIV, Antiretroviral therapy, Differentiated care, Expedited services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early fast-track careOther
Participants will be eligible for fast-track care at 8 weeks if their HIV-1 RNA is <200 copies/mL and they meet other eligibility criteria. If HIV-1 RNA is 200 copies/mL or higher at 8 weeks, then it will be repeated at 12 weeks, and those with HIV-1 RNA <200 copies will then be eligible for fast-track care, if they meet other eligibility criteria.
Standard (deferred fast-track) careOther
Participants will be eligible for fast-track care at 24 weeks, if their HIV-1 RNA is <200 copies.mL, and they meet other eligibility criteria.
| Study group | Role | What they receive |
|---|---|---|
| Early Fast-Track Care | Experimental | Participants will be eligible for fast-track care after 8 to 12 weeks, if viral load is suppressed (<200 copies/mL) Receives: Other: Early fast-track care |
| Standard (Deferred Fast-track) Care | Active comparator | Participants will be eligible for fast-track care after 24 weeks, if viral load is suppressed (<200 weeks) Receives: Other: Standard (deferred fast-track) care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral suppression - 200 copies/mL cut-off
Proportion of participants with HIV-1 RNA <200 copies/mL
Measured: 48 weeks after study enrollment
Secondary outcomes (6)
Viral suppression - 50 copies/mL cut-off
Proportion of participants with HIV-1 RNA <50 copies/mL
Measured: 48 weeks after study enrollment
Viral suppression - 1000 copies/mL cut-off
Proportion of participants with HIV-1 RNA <1000 copies/mL
Measured: 48 weeks after study enrollment
Adherence of at least 90%
Adherence to antiretroviral therapy of at least 90% as measured by pharmacy refill records
Measured: 48 weeks after enrollment
Medication tolerability
Proportion of participants discontinuing tenofovir disoproxil/lamivudine/dolutegravir regimen
Measured: 48 weeks after enrollment
Cost
Total cost of early fast-track and standard (deferred fast-track) care from the health center perspective
Measured: 48 weeks after enrollment
Time in clinic
Median time in clinic
Measured: 48 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Sep 2020 (estimated)
- Primary completion28 Feb 2022 (estimated)
- Study completion29 May 2022 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized in a 1:1 ratio to early fast-track vs. standard care.
- Masking
- None (open label)
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Weill Medical College of Cornell University, Florida International University
- Responsible party
- Sponsor
- Investigators
- Colette Guiteau, MD, Principal investigator, Haitian Group for the Study of Kaposi's Sarcoma and OpportunisticSerena Koenig, MD, Principal investigator, Brigham and Women's Hospital/Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311944
- Sponsor's protocol ID
- 212336
- Status last verified
- Jul 2020
- First submitted
- 15 Mar 2020
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared at the end of the study.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Fast-Track Versus Standard Care for Persons With HIV Initiating Tenofovir Disoproxil Fumarate-Lamivudine-Dolutegravir (TLD) in Haiti: A Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT04311944
- Acronym / sponsor ID
- 212336
- Conditions
- HIV-1-infection
- Keywords
- HIV, Antiretroviral therapy, Differentiated care, Expedited services
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Haitian Group for the Study of Kaposi's Sarcoma and OpportunisticUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Weill Medical College of Cornell University, Florida International University
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 29 May 2022 (estimated)
- First posted
- 17 Mar 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 will evaluate the clinical efficacy of using earlier fast-track services compared to the standard of care in a clinical setting to improve retention in care and virologic suppression for patients who are initiating a dolutegravir-based antiretroviral therapy regimen.
Detailed description
With current approaches to HIV care, patients generally do not qualify for expedited services until they have been in care for 6 to 12 months. Once they have achieved an undetectable viral load and/or high adherence, patients qualify for expedited services with fewer clinic visits. The problem with this approach is that it's time-intensive early in ART care, when attrition rates are highest. A potential solution to this problem is to provide earlier fast-track care for patients on dolutegravir-based regimens with viral suppression. This strategy is feasible due to the high potency and rapid declines in viral load with dolutegravir-based regimens.
We will compare a strategy of early fast-track care (8 to 12 weeks, for patients with viral suppression) versus standard initiation of fast-track care (after 6 months in care, with viral suppression). All participants will receive the same ART regimen, the combination regimen of Tenofovir Disoproxil Fumarate-Lamivudine-Dolutegravir.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized in a 1:1 ratio to early fast-track vs. standard care.
| Arm | Type | Receives |
|---|---|---|
| Early Fast-Track Care | Experimental | Other: Early fast-track careParticipants will be eligible for fast-track care after 8 to 12 weeks, if viral load is suppressed (<200 copies/mL) |
| Standard (Deferred Fast-track) Care | Active comparator | Other: Standard (deferred fast-track) careParticipants will be eligible for fast-track care after 24 weeks, if viral load is suppressed (<200 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Documentation of positive HIV status (test conducted at GHESKIO)
- Age ≥18 years of age
- Eligible for TLD regimen, according to Haitian Ministry of Health guidelines
- Initiate ART within 3 days prior to enrollment
- Lives in Port-au-Prince metropolitan area
Key exclusion criteria (8 listed)
- Not ART-naïve (history of ART for any duration in the past)
- World Health Organization Stage 3 or 4 disease;
- Pregnancy or breastfeeding at the screening visit;
- Planning to become pregnant during the study period;
- Active drug, alcohol use, or mental condition that would interfere with the ability to adhere to study requirements, in the opinion of the study physician;
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 |
|---|---|---|
| Early fast-track careParticipants will be eligible for fast-track care at 8 weeks if their HIV-1 RNA is <200 copies/mL and they meet other eligibility criteria. If HIV-1 RNA is 200 copies/mL or higher at 8 weeks, then it will be repeated at 12 weeks, and those with HIV-1 RNA <200 copies will then be eligible for fast-track care, if they meet other eligibility criteria. | Other | Early Fast-Track Care |
| Standard (deferred fast-track) careParticipants will be eligible for fast-track care at 24 weeks, if their HIV-1 RNA is <200 copies.mL, and they meet other eligibility criteria. | Other | Standard (Deferred Fast-track) Care |
Primary outcome
Viral suppression - 200 copies/mL cut-off
Time frame: 48 weeks after study enrollment
Proportion of participants with HIV-1 RNA <200 copies/mL
6 secondary outcomes
Viral suppression - 50 copies/mL cut-off
Time frame: 48 weeks after study enrollment
Viral suppression - 1000 copies/mL cut-off
Time frame: 48 weeks after study enrollment
Adherence of at least 90%
Time frame: 48 weeks after enrollment
Medication tolerability
Time frame: 48 weeks after enrollment
Cost
Time frame: 48 weeks after enrollment
Time in clinic
Time frame: 48 weeks after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Individual participant dataSharing planned: Yes. De-identified data will be shared at the end of the study.
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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.
Colette Guiteau, MD principal investigator
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
Serena Koenig, MD principal investigator
Brigham and Women's Hospital/Harvard Medical School
Questions about this trial
What is this clinical trial studying?
A study testing Early fast-track care and Standard (deferred fast-track) care in people with HIV-1-infection, run by Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic.
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 8 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: status not confirmed, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Colette Guiteau, MD (3449-3596, colette0786@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral suppression - 200 copies/mL cut-off (time frame: 48 weeks after study enrollment). 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 31 Jul 2020.