HIVPhase 4A-TRI-WEEKNCT01778413
Virological and Immunological Safety of a Dose Reduction Strategy Antiretroviral Regimen With Efavirenz / Tenofovir / Emtricitabine
A Phase 4 study testing ATRIPLA in people with HIV, run by Anna Cruceta at 1 site in Spain.
Trial summary
The main objective is to determine the feasibility of maintaining virologic suppression on standard plasma viral load by dose reduction of ATRIPLA ®. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- ATRIPLA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSpain
- Study dates
- 3 Jun 2013to 21 Jul 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adults (≥ 18 years)
- HIV-1 infection, clinical stability, and treatment with ATRIPLA ® for the past two years.
- Standard plasma viral load below the limit of detection for at least 2 years.
- CD4 count above 350/mm3 at the time of the consideration for the study.
- Negative pregnancy test in women of childbearing age, and commitment acceptable contraceptive use for at least 2 weeks before day 1 and until at least 6 months after the last dose of study drug.
- Patients should be given written informed consent
- In the opinion of the investigator, be able to follow the design of the protocol visits
Who cannot join
- Patients who have experienced virologic failure prior to any antiretroviral regimen
- Evidence of previous mutations versus efavirenz, tenofovir and emtricitabine
- Use of any other chronic treatment plus ATRIPLA has been introduced in the 6 months prior to entry of the patient in the study
- Any contraindication to study drug
- Any condition not ensure proper adherence to the study at the discretion of the attending physician of the patient
- Uncontrolled preexisting psychiatric illness
- Any current sign of alcoholism or other drug use.
Trial locations and contacts
1 site in 1 country.
About this study
The main objective is to determine the feasibility of maintaining virologic suppression on standard plasma viral load by dose reduction of ATRIPLA ®.
Read the detailed description
The main objective of this study is to determine the feasibility of maintaining virologic suppression on standard plasma viral load (limit of detection 37 copies / mL) of a dose reduction strategy of ATRIPLA ® once a day to three tablets per week in patients infected with HIV-1 with sustained suppression of plasma viral load standard for more than two years.
- Conditions
- HIV
- Being tested
- ATRIPLA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATRIPLADrug
Also called efavirenz/emtricitabine/tenofovir disoproxil fumarate 600 mg/200, mg/245 mg
| Study group | Role | What they receive |
|---|---|---|
| ATRIPLA three times a week. | Experimental | Atripla (600 mg/200 mg/245 mg) three times a week. Receives: Drug: ATRIPLA |
| ATRIPLA one time a day. | Active comparator | Atripla (600 mg/200 mg/245 mg) one time a day. Receives: Drug: ATRIPLA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Free of Treatment Failure (Noncompleter = Failure) at 24 Weeks.
Treatment failure defined as any of the following possibilities occurring within the 24-week study framework: virological failure (confirmed plasma viral load 37 copies/ml), discontinuation of the antiretroviral therapy schedule irrespective of the reason, consent withdrawal, lost to follow-up, pregnancy, inability to comply with the study or any other reason that could make the doctor in charge consider the cessation of the study.
Measured: 24 weeks
Secondary outcomes (9)
The Proportion of Patients With Ultrasensitive Viral Load (<1 Copy / mL) After 24 Weeks.
Measured: 24 weeks
The Change From Baseline to 24 Weeks in the Viral Reservoir in Peripheral Blood Mononuclear Cells
Measured: baseline and 6 months
Immunological
Changes from baseline to 24 weeks in the production of TRECs, the immunological profile of activation (CD38 and HLA-DR) and senescence (CD57 and CD28) in CD4 and CD8 lineages in the proportions of naive T cells effector and memory (CCR7 and CD45RA), and changes in the levels of apoptosis in vitro by staining with annexin V.
Measured: baseline and 6 months
Changes in Plasma Levels of Efavirenz.
Measured: baseline and 6 months
Changes in Sleep Quality (Pittsburgh Sleep Quality Index).
Measured: baseline and 6 months
General Safety (Report Adverse Events, Serious Adverse Events and Treatment Discontinuation Due to Adverse Events)
Measured: 24 weeks
Changes in Plasma Levels of Vitamin D.
Measured: baseline and 6 months
Changes in Lipid Profile.
Measured: baseline and 6 months
Changes in Estimated Glomerular Filtration Rate.
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study start3 Jun 2013
- Primary completion14 Nov 2014
- Study completion21 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anna Cruceta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Esteban Martinez, MD, Principal investigator, Hospital Clínic i Provincial de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778413
- Sponsor's protocol ID
- A-TRI-WEEK
- Acronym
- A-TRI-WEEK
- Status last verified
- Jul 2025
- First submitted
- 18 Jan 2013
- Last updated
- 18 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Borjabad B, Rojas J, Inciarte A, Sempere A, Chivite I, Gonzalez-Cordon A, Mosquera MM, Torres B, Calvo J, de la Mora L, Martinez-Rebollar M, Laguno M, Foncillas A, Ambrosioni J, Alcami J, Miro JM, Blanco JL, Sanchez-Palomino S, Blanch J, de Lazzari E, Martinez E. Short-cycle three-day-per-week efavirenz/emtricitabine/tenofovir disoproxil fumarate therapy: a seven-year extension study. J Antimicrob Chemother. 2026 Feb 2;81(3):dkag040. doi: 10.1093/jac/dkag040.
PubMed 41676981Guardo AC, Zarama A, Gonzalez T, Bargallo ME, Rojas J, Martinez E, Plana M, Sanchez-Palomino S. Effects on immune system and viral reservoir of a short-cycle antiretroviral therapy in virologically suppressed HIV-positive patients. AIDS. 2019 May 1;33(6):965-972. doi: 10.1097/QAD.0000000000002169.
PubMed 30946150Rojas J, Blanco JL, Sanchez-Palomino S, Marcos MA, Guardo AC, Gonzalez-Cordon A, Lonca M, Tricas A, Rodriguez A, Romero A, Miro JM, Mallolas J, Gatell JM, Plana M, Martinez E. A maintenance 3-day-per-week schedule with the single tablet regimen efavirenz/emtricitabine/tenofovir disoproxil fumarate is effective and decreases sub-clinical toxicity. AIDS. 2018 Jul 31;32(12):1633-1641. doi: 10.1097/QAD.0000000000001843.
PubMed 29746294
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virological and Immunological Safety of a Dose Reduction Strategy Antiretroviral Regimen With Efavirenz / Tenofovir / Emtricitabine
- ClinicalTrials.gov ID
- NCT01778413
- Acronym / sponsor ID
- A-TRI-WEEK / A-TRI-WEEK
- Conditions
- HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Anna CrucetaUniversity, hospital or other
- Study start
- 3 Jun 2013 (actual)
- Primary completion
- 14 Nov 2014 (actual)
- Study completion
- 21 Jul 2015 (actual)
- First posted
- 29 Jan 2013 (estimated)
- Results
- Posted 18 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective is to determine the feasibility of maintaining virologic suppression on standard plasma viral load by dose reduction of ATRIPLA ®.
Detailed description
The main objective of this study is to determine the feasibility of maintaining virologic suppression on standard plasma viral load (limit of detection 37 copies / mL) of a dose reduction strategy of ATRIPLA ® once a day to three tablets per week in patients infected with HIV-1 with sustained suppression of plasma viral load standard for more than two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATRIPLA three times a week. | Experimental | Drug: ATRIPLAAtripla (600 mg/200 mg/245 mg) three times a week. |
| ATRIPLA one time a day. | Active comparator | Drug: ATRIPLAAtripla (600 mg/200 mg/245 mg) one time a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults (≥ 18 years)
- HIV-1 infection, clinical stability, and treatment with ATRIPLA ® for the past two years.
- Standard plasma viral load below the limit of detection for at least 2 years.
- CD4 count above 350/mm3 at the time of the consideration for the study.
- Negative pregnancy test in women of childbearing age, and commitment acceptable contraceptive use for at least 2 weeks before day 1 and until at least 6 months after the last dose of study drug.
Key exclusion criteria (7 listed)
- Patients who have experienced virologic failure prior to any antiretroviral regimen
- Evidence of previous mutations versus efavirenz, tenofovir and emtricitabine
- Use of any other chronic treatment plus ATRIPLA has been introduced in the 6 months prior to entry of the patient in the study
- Any contraindication to study drug
- Any condition not ensure proper adherence to the study at the discretion of the attending physician of the patient
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 |
|---|---|---|
| ATRIPLAAlso: efavirenz/emtricitabine/tenofovir disoproxil fumarate 600 mg/200, mg/245 mg | Drug | ATRIPLA one time a day., ATRIPLA three times a week. |
Primary outcome
Proportion of Patients Free of Treatment Failure (Noncompleter = Failure) at 24 Weeks.
Time frame: 24 weeks
Treatment failure defined as any of the following possibilities occurring within the 24-week study framework: virological failure (confirmed plasma viral load 37 copies/ml), discontinuation of the antiretroviral therapy schedule irrespective of the reason, consent withdrawal, lost to follow-up, pregnancy, inability to comply with the study or any other reason that could make the doctor in charge consider the cessation of the study.
9 secondary outcomes
The Proportion of Patients With Ultrasensitive Viral Load (<1 Copy / mL) After 24 Weeks.
Time frame: 24 weeks
The Change From Baseline to 24 Weeks in the Viral Reservoir in Peripheral Blood Mononuclear Cells
Time frame: baseline and 6 months
Immunological
Time frame: baseline and 6 months
Changes in Plasma Levels of Efavirenz.
Time frame: baseline and 6 months
Changes in Sleep Quality (Pittsburgh Sleep Quality Index).
Time frame: baseline and 6 months
General Safety (Report Adverse Events, Serious Adverse Events and Treatment Discontinuation Due to Adverse Events)
Time frame: 24 weeks
Changes in Plasma Levels of Vitamin D.
Time frame: baseline and 6 months
Changes in Lipid Profile.
Time frame: baseline and 6 months
Changes in Estimated Glomerular Filtration Rate.
Time frame: baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41676981Borjabad B, Rojas J, Inciarte A, Sempere A, Chivite I, Gonzalez-Cordon A, Mosquera MM, Torres B, Calvo J, de la Mora L, Martinez-Rebollar M, Laguno M, Foncillas A, Ambrosioni J, Alcami J, Miro JM, Blanco JL, Sanchez-Palomino S, Blanch J, de Lazzari E, Martinez E. Short-cycle three-day-per-week efavirenz/emtricitabine/tenofovir disoproxil fumarate therapy: a seven-year extension study. J Antimicrob Chemother. 2026 Feb 2;81(3):dkag040. doi: 10.1093/jac/dkag040.
- Derived from this study: PubMed 30946150Guardo AC, Zarama A, Gonzalez T, Bargallo ME, Rojas J, Martinez E, Plana M, Sanchez-Palomino S. Effects on immune system and viral reservoir of a short-cycle antiretroviral therapy in virologically suppressed HIV-positive patients. AIDS. 2019 May 1;33(6):965-972. doi: 10.1097/QAD.0000000000002169.
- Derived from this study: PubMed 29746294Rojas J, Blanco JL, Sanchez-Palomino S, Marcos MA, Guardo AC, Gonzalez-Cordon A, Lonca M, Tricas A, Rodriguez A, Romero A, Miro JM, Mallolas J, Gatell JM, Plana M, Martinez E. A maintenance 3-day-per-week schedule with the single tablet regimen efavirenz/emtricitabine/tenofovir disoproxil fumarate is effective and decreases sub-clinical toxicity. AIDS. 2018 Jul 31;32(12):1633-1641. doi: 10.1097/QAD.0000000000001843.
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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.
Esteban Martinez, MD principal investigator
Hospital Clínic i Provincial de Barcelona
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 ATRIPLA in people with HIV, run by Anna Cruceta 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 7 inclusion and 7 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 18 Jul 2025. 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 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?
Yes. Results are posted in the registry (first posted 18 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Patients Free of Treatment Failure (Noncompleter = Failure) at 24 Weeks. (time frame: 24 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 NCT01778413, which also lists 3 linked publications.
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 18 Jul 2025.