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The main objective is to determine the feasibility of maintaining virologic suppression on standard plasma viral load by dose reduction of ATRIPLA ®.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATRIPLA three times a week. | Experimental | Atripla (600 mg/200 mg/245 mg) three times a week. |
|
| ATRIPLA one time a day. | Active Comparator | Atripla (600 mg/200 mg/245 mg) one time a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATRIPLA | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Patients With Ultrasensitive Viral Load (<1 Copy / mL) After 24 Weeks. | 24 weeks | |
| The Change From Baseline to 24 Weeks in the Viral Reservoir in Peripheral Blood Mononuclear Cells | baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esteban Martinez, MD | Hospital ClÃnic i Provincial de Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic i Provincial Barcelona | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41676981 | Derived | 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. | |
| 30946150 |
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68 patients were assessed for eligibility, 61 underwent randomization and received at least one dose of study drugs. Seven patients were excluded because of refusal to participate (lack of time, n¼4; lack of interest, n¼1; fear of viral failure, n¼1) or evidence of illicit drug consumption (n¼1).
Participants were recruited between 3 June 2013 and 30 May 2014 at Hospital ClÃnic of Barcelona.
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| ID | Title | Description |
|---|---|---|
| FG000 | ATRIPLA Three Days a Week (3W) | Atripla (600 mg/200 mg/245 mg) three days a week (Mondays, Wednesdays and Fridays). |
| FG001 | ATRIPLA One Time a Day (OD) | Atripla (600 mg/200 mg/245 mg) one time a day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ATRIPLA Three Days a Week (3W) | Atripla (600 mg/200 mg/245 mg) three days a week (Mondays, Wednesdays and Fridays). |
| BG001 | ATRIPLA One Time a Day (OD) | Atripla (600 mg/200 mg/245 mg) one time a day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 24 weeks |
|
24 weeks
AE/SAE definitions were consistent with ClinicalTrials.gov, but also included clinically significant lab abnormalities and events related to overdose, abuse, or withdrawal.
AEs were collected systematically at baseline, weeks 12 and 24 in both arms, and at weeks 1, 2, 4, 6, and 8 in the 3-day/week arm. Grading used DAIDS Table v1.0 (Dec 2004; Clarified Aug 2009).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ATRIPLA Three Days a Week (3W) | Atripla (600 mg/200 mg/245 mg) three days a week (Mondays, Wednesdays and Fridays). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild, non-serious adverse events | General disorders | DAIDS v1.0, 2009 | Systematic Assessment | All reported events were grade 1-2, not related to study drug |
This was a single-center, open-label, pilot study with a small sample size (N=61) and short follow-up (24 weeks). The study was not powered to detect rare adverse events or long-term outcomes. No formal non-inferiority analysis was conducted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Esteban Martinez | Hospital ClÃnic de Barcelona | 932275400 | estebanm@clinic.cat |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 30, 2012 | Jun 13, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000068257 | Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| C098320 | efavirenz |
| D000068679 | Emtricitabine |
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D010078 | Oxazines |
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| 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. | baseline and 6 months |
| Changes in Plasma Levels of Efavirenz. | baseline and 6 months |
| Changes in Sleep Quality (Pittsburgh Sleep Quality Index). | baseline and 6 months |
| General Safety (Report Adverse Events, Serious Adverse Events and Treatment Discontinuation Due to Adverse Events) | 24 weeks |
| Changes in Plasma Levels of Vitamin D. | baseline and 6 months |
| Changes in Lipid Profile. | baseline and 6 months |
| Changes in Estimated Glomerular Filtration Rate. | baseline and 6 months |
| Derived |
| Guardo 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. |
| 29746294 | Derived | Rojas 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Atripla (600 mg/200 mg/245 mg) one time a day. |
|
|
| Secondary | The Proportion of Patients With Ultrasensitive Viral Load (<1 Copy / mL) After 24 Weeks. | Not Posted | 24 weeks | Participants |
| Secondary | The Change From Baseline to 24 Weeks in the Viral Reservoir in Peripheral Blood Mononuclear Cells | Not Posted | baseline and 6 months | Participants |
| Secondary | 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. | Not Posted | baseline and 6 months | Participants |
| Secondary | Changes in Plasma Levels of Efavirenz. | Not Posted | baseline and 6 months | Participants |
| Secondary | Changes in Sleep Quality (Pittsburgh Sleep Quality Index). | Not Posted | baseline and 6 months | Participants |
| Secondary | General Safety (Report Adverse Events, Serious Adverse Events and Treatment Discontinuation Due to Adverse Events) | Not Posted | 24 weeks | Participants |
| Secondary | Changes in Plasma Levels of Vitamin D. | Not Posted | baseline and 6 months | Participants |
| Secondary | Changes in Lipid Profile. | Not Posted | baseline and 6 months | Participants |
| Secondary | Changes in Estimated Glomerular Filtration Rate. | Not Posted | baseline and 6 months | Participants |
| 0 |
| 30 |
| 0 |
| 30 |
| 13 |
| 30 |
| EG001 | ATRIPLA One Time a Day (OD) | Atripla (600 mg/200 mg/245 mg) one time a day. | 0 | 31 | 0 | 31 | 11 | 31 |
|
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| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |