HIV InfectionsPhase 3VIRECURENCT02588820
Impact of Extremely Early Antiretroviral Therapy to Reduce VIral REservoir and Induce Functional CURE of HIV-1 Infection
A Phase 3 study testing Antiretroviral Therapy (Experimental) in people with HIV Infections, run by David Garcia Cinca at 1 site in Spain.
Trial summary
Pilot study to evaluate the impact of extremely early ART in the dynamics of viral reservoir, immune activation and inflammation in patients with HIV-1 infection of less than 20 days (Fiebig stages I-II) compared to patients with infection of 20-100 days (Fiebig stages III-V), to induce HIV functional cure. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- HIV Infections
- What is being tested?
- Antiretroviral Therapy (Experimental)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2016to Nov 2018
- 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 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men who have sex with men
- Male's between18 and 65 years old
- Less than 100 days of infection
- Patient stage Fiebig I to V
- Negative or Incomplete western blot with negative p31 band
Who cannot join
- P31 positive band in western blot
- Positive Delta32 CCR5 mutation, HLA-B5701 or HLA-B27 (´late' exclusion criteria)
- Active oncological disease
- Active hepatitis C virus infection
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic i Provincial de Barcelona
Barcelona, Barcelona, 08036
Josep Maria Miró, MD, +34 337 54 00
About this study
Official title: Impact of Extremely Early Antiretroviral Therapy to Reduce VIral REservoir and Induce Functional CURE of HIV-1 Infection: A Pilot Comparative Study
Pilot study to evaluate the impact of extremely early ART in the dynamics of viral reservoir, immune activation and inflammation in patients with HIV-1 infection of less than 20 days (Fiebig stages I-II) compared to patients with infection of 20-100 days (Fiebig stages III-V), to induce HIV functional cure.
- Conditions
- HIV Infections
- Being tested
- Antiretroviral Therapy (Experimental)
- Keywords
- HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiretroviral Therapy (Experimental)Drug
- Initial ART until HLA-B5701 results became available (48 hours):
- Tenofovir 245 mg once a day
- Emtricitabine 200 mg once a day
- Dolutegravir 50 mg once a day
- Darunavir 800 mg once a day
- Ritonavir 100 mg once a day
- Maraviroc 150 mg twice a day
- Three months continuation treatment (after HLA-B5701 confirmed as negative):
- Dolutegravir 50 mg once a day.
- Abacavir 600 mg once a day
- Lamivudine 300 mg once a day
- Darunavir 800 mg once a day
- Ritonavir 100 mg once a day
- Maraviroc 150 mg twice a day The whole treatment schedule comprises 7 pills per day (in a single dose), except for maraviroc, which will be given twice daily.
- Nine months continuation treatment (till complete 12 months treatment):
- Abacavir, 600mg once a day
- Lamivudine, 300 mg once a day
- Dolutegravir, 50 mg once a day
| Study group | Role | What they receive |
|---|---|---|
| Antiretroviral treatment | Experimental | Not described Receives: Drug: Antiretroviral Therapy (Experimental) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional cure (Proportion of patients with undetectable viral reservoir)
Proportion of patients in both groups with undetectable viral reservoir in peripheral and rectal tissue CD4+ T cells. A viral load will be performed at 1, 3 and 12 months after ART initiation and in rectal tissue at one year post-ART initiation.
Measured: 12 months of treatment
Secondary outcomes (5)
Proportion of patients with undetectable plasmatic HIV viral load
In those patients with undetectable viral reservoir stopping antiretroviral treatment at 12 months
Measured: 1, 3 and 12 months post-stop antiretroviral treatment will be evaluated.
Level of reduction of viral reservoir among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V
Measured: 1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop
Level of reduction of bacterial translocation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V
Measured: 1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop
Level of reduction of immune activation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V
Measured: 1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop
Level of reduction of inflammation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V
Measured: 1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startApr 2016
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Garcia Cinca
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion Clinic per a la Recerca Biomédica
- Responsible party
- Sponsor-investigator, David Garcia Cinca, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588820
- Sponsor's protocol ID
- 2015-000251-24
- Other IDs
- 2015
- Acronym
- VIRECURE
- Status last verified
- Aug 2016
- First submitted
- 20 Oct 2015
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Extremely Early Antiretroviral Therapy to Reduce VIral REservoir and Induce Functional CURE of HIV-1 Infection: A Pilot Comparative Study
- ClinicalTrials.gov ID
- NCT02588820
- Acronym / sponsor ID
- VIRECURE / 2015-000251-24
- Conditions
- HIV Infections
- Keywords
- HIV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- David Garcia CincaUniversity, hospital or other
- Collaborators
- Fundacion Clinic per a la Recerca Biomédica
- Study start
- Apr 2016
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 28 Oct 2015 (estimated)
- 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.
Pilot study to evaluate the impact of extremely early ART in the dynamics of viral reservoir, immune activation and inflammation in patients with HIV-1 infection of less than 20 days (Fiebig stages I-II) compared to patients with infection of 20-100 days (Fiebig stages III-V), to induce HIV functional cure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antiretroviral treatment | Experimental | Drug: Antiretroviral Therapy (Experimental) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men who have sex with men
- Male's between18 and 65 years old
- Less than 100 days of infection
- Patient stage Fiebig I to V
- Negative or Incomplete western blot with negative p31 band
Key exclusion criteria (4 listed)
- P31 positive band in western blot
- Positive Delta32 CCR5 mutation, HLA-B5701 or HLA-B27 (´late' exclusion criteria)
- Active oncological disease
- Active hepatitis C virus infection
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 |
|---|---|---|
| Antiretroviral Therapy (Experimental)1. Initial ART until HLA-B5701 results became available (48 hours): 1. Tenofovir 245 mg once a day 2. Emtricitabine 200 mg once a day 3. Dolutegravir 50 mg once a day 4. Darunavir 800 mg once a day 5. Ritonavir 100 mg once a day 6. Maraviroc 150 mg twice a day 2. Three months continuation treatment (after HLA-B5701 confirmed as negative): 1. Dolutegravir 50 mg once a day. 2. Abacavir 600 mg once a day 3. Lamivudine 300 mg once a day 4. Darunavir 800 mg once a day 5. Ritonavir 100 mg once a day 6. Maraviroc 150 mg twice a day The whole treatment schedule comprises 7 pills per day (in a single dose), except for maraviroc, which will be given twice daily. 3. Nine months continuation treatment (till complete 12 months treatment): 1. Abacavir, 600mg once a day 2. Lamivudine, 300 mg once a day 3. Dolutegravir, 50 mg once a day | Drug | Antiretroviral treatment |
Primary outcome
Functional cure (Proportion of patients with undetectable viral reservoir)
Time frame: 12 months of treatment
Proportion of patients in both groups with undetectable viral reservoir in peripheral and rectal tissue CD4+ T cells. A viral load will be performed at 1, 3 and 12 months after ART initiation and in rectal tissue at one year post-ART initiation.
5 secondary outcomes
Proportion of patients with undetectable plasmatic HIV viral load
Time frame: 1, 3 and 12 months post-stop antiretroviral treatment will be evaluated.
Level of reduction of viral reservoir among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V
Time frame: 1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop
Level of reduction of bacterial translocation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V
Time frame: 1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop
Level of reduction of immune activation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V
Time frame: 1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop
Level of reduction of inflammation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V
Time frame: 1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antiretroviral Therapy (Experimental) in people with HIV Infections, run by David Garcia Cinca at 1 site in Spain.
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 5 inclusion and 4 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 17 Aug 2016. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional cure (Proportion of patients with undetectable viral reservoir) (time frame: 12 months of treatment). 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 17 Aug 2016.