Human Immunodeficiency Virus Infection (HIV)NCT07703748
Long-Term Real-World Evidence Study to Evaluate Effectiveness, Persistence, Adherence, Safety and Tolerability of Long-acting Cabotegravir Plus Rilpivirine.
An observational study of Human Immunodeficiency Virus Infection (HIV) and HIV-1 Infection in Adults, run by FUNDACIÓN HOSPITAL UNIVERSITARIO INFANTA LEONOR Y DEL HOSPITAL UNIVERSITARIO DEL SURESTE at 1 site in Spain.
Trial summary
The RELATIVITY study is a nationwide, multicenter, ambispective observational cohort evaluating the long-term effectiveness, safety, persistence, and tolerability of long-acting injectable cabotegravir plus rilpivirine (CAB+RPV LA) in people living with HIV in Spain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus Infection (HIV), HIV-1 Infection in Adults
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 3,346 participants
- Where
- 1 siteSpain
- Study dates
- 31 Dec 2024to 30 Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study population consists of adults (≥18 years) living with HIV-1 receiving routine care in Spain who achieved virological suppression on oral antiretroviral therapy and switched to long-acting intramuscular cabotegravir plus rilpivirine (CAB+RPV LA) according to routine clinical practice. Participants are enrolled from 58 hospitals across Spain in a nationwide ambispective observational cohort. The study includes a broad and representative real-world population, including older adults, women, migrants, people with obesity, individuals with multimorbidity, and other clinically relevant subgroups. Approximately 4,000 participants are expected to be included and followed for up to 5 years after treatment initiation.
Who may be able to join
- Adults aged ≥18 years.
- Documented HIV-1 infection.
- Receiving oral antiretroviral therapy with plasma HIV-1 RNA <50 copies/mL at the time of switching to long-acting cabotegravir plus rilpivirine (CAB+RPV LA).
- No current or previous evidence of resistance to non-nucleoside reverse transcriptase inhibitors (NNRTIs) or integrase strand transfer inhibitors (INSTIs), and no previous virological failure with these drug classes.
- Received at least one injection of CAB+RPV LA before January 1, 2025.
- Able to understand and provide written informed consent.
Who cannot join
- Any contraindication to CAB+RPV LA according to the approved product labeling.
- Previous exposure to long-acting CAB+RPV within an interventional clinical trial.
- Active hepatitis B infection (HBsAg positive).
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RETROSPECTIVE AND PROSPECTIVE MULTICENTER STUDY EVALUATING LONG TERM EFFECTIVENESS AND SAFETY OF CABOTEGRAVIR AND RILPIVIRINE IN REAL LIFE AS A LONG-ACTING TREATMENT IN PEOPLE LIVING WITH HIV AFTER ITS IMPLEMENTATION IN SPAIN. RELATIVITY COHORT
The RELATIVITY study is a nationwide, multicenter, ambispective observational cohort evaluating the long-term effectiveness, safety, persistence, and tolerability of long-acting injectable cabotegravir plus rilpivirine (CAB+RPV LA) in people living with HIV in Spain.
The study includes adults with HIV-1 infection who achieved virological suppression on oral antiretroviral therapy and switched to long-acting CAB+RPV as part of routine clinical care. No study-specific treatment or interventions are performed. Clinical information is collected retrospectively from treatment initiation and prospectively during routine follow-up.
The primary objectives are to evaluate long-term virological effectiveness, treatment persistence, and confirmed virological failure over five years. Secondary objectives include assessment of safety, treatment discontinuation, adherence to injection schedules, immunological outcomes, metabolic changes, patient-reported outcomes, and factors associated with treatment success or failure. The study also evaluates outcomes in clinically relevant subgroups, including older adults, women, migrants, people with obesity, individuals with multimorbidity, and those infected through vertical transmission.
Read the detailed description
The RELATIVITY cohort is a national, multicenter, ambispective, non-interventional observational study designed to evaluate the long-term real-world effectiveness, safety, persistence, adherence, and tolerability of long-acting injectable cabotegravir plus rilpivirine (CAB+RPV LA) following its implementation into routine HIV care in Spain.
The study includes adults with HIV-1 infection who were virologically suppressed on oral antiretroviral therapy and switched to CAB+RPV LA according to routine clinical practice and approved prescribing information. Treatment decisions are entirely independent of study participation. No investigational intervention, randomization, or protocol-mandated treatment procedures are performed.
Participants receiving at least one injection of CAB+RPV LA between January 2023 and December 2024 are included through retrospective data collection, followed by prospective observation for up to five years after treatment initiation. Clinical data are collected from electronic medical records and entered into a centralized electronic case report form (eCRF). Follow-up reflects routine clinical practice at each participating center.
The primary study objectives are to evaluate:
Long-term maintenance of virological suppression. Treatment persistence. Time to confirmed virological failure.
Secondary objectives include evaluation of:
Safety and tolerability, including adverse events and injection-site reactions. Reasons for treatment discontinuation. Adherence to scheduled injection visits and oral bridging strategies. Virological rebounds and emergence of resistance-associated mutations. Immunological evolution (CD4 count, CD8 count, CD4/CD8 ratio). Changes in metabolic, renal, and hepatic parameters. Health-related quality of life and treatment satisfaction in a subset of participants.
Exploratory analyses will evaluate outcomes in clinically important subgroups, including older adults, women, migrants, individuals with obesity, multimorbidity, vertical HIV transmission, baseline resistance testing availability, and patients with previous adherence challenges to oral antiretroviral therapy.
Approximately 4,000 participants from 58 hospitals across Spain are expected to be included, making RELATIVITY one of the largest real-world cohorts evaluating long-acting injectable antiretroviral therapy. The study aims to generate robust evidence on the long-term use of CAB+RPV LA in routine clinical practice and to complement findings from randomized clinical trials by evaluating broader and more representative patient populations
- Keywords
- Long-acting, cabotegravir, rilpivirine, CAB+RPV, Antiretroviral therapy, Real-world evidence, Observational cohort, Virological suppression, Treatment persistence, Adherence, RELATIVITY cohort, Quality of life, Injection site reactions
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Injection Site Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RELATIVITY | Adults living with HIV-1 who achieved virological suppression on oral antiretroviral therapy and switched to long-acting intramuscular cabotegravir plus rilpivirine (CAB+RPV LA), administered every two months according to routine clinical practice and approved prescribing information in Spain. Participants are enrolled in a nationwide multicenter ambispective observational cohort and followed longitudinally to evaluate long-term effectiveness, treatment persistence, safety, adherence, tolerability, and virological outcomes. No study-specific intervention or treatment allocation is performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with HIV-1 RNA ≥50 copies/mL
Proportion of participants with plasma HIV-1 RNA ≥50 copies/mL after initiation of long-acting cabotegravir plus rilpivirine, assessed according to the FDA Snapshot algorithm.
Measured: Month 12, Month 24, Month 36, Month 48, and Month 60
Secondary outcomes (1)
Treatment persistence with CAB+RPV LA
Proportion of participants who remain receiving long-acting cabotegravir plus rilpivirine during follow-up
Measured: From baseline to Month 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start31 Dec 2024
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency Virus Infection (HIV)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,346 participants (actual)
Sponsor and investigators
- Lead sponsor
- FUNDACIÓN HOSPITAL UNIVERSITARIO INFANTA LEONOR Y DEL HOSPITAL UNIVERSITARIO DEL SURESTE
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario de Burgos
- Responsible party
- Principal investigator, Jesus Troya, FUNDACIÓN HOSPITAL UNIVERSITARIO INFANTA LEONOR Y DEL HOSPITAL UNIVERSITARIO DEL SURESTE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703748
- Sponsor's protocol ID
- FBIS-RELATIVITY
- Other IDs
- ISS#306336
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in publications derived from this study will be made available upon reasonable request to the corresponding author. Data sharing will be considered for scientifically sound research proposals after approval by the study steering committee, the sponsor, and the relevant ethics committees, when applicable. Data will be shared only after execution of an appropriate data sharing agreement and in compliance with applicable data protection regulations (including GDPR) and institutional policies.
Publications
Buzon-Martin L, Montes ML, Pedrero R, Galindo MJ, Santacreu-Guerrero M, Aleman MR, Torralba M, Diaz de Santiago A, Fanjul F, Rodriguez A, Cabello A, Crusells MJ, Navarro MDC, Aguilera M, Hidalgo-Tenorio C, Morano-Amado LE, Vinuesa D, De Andres C, Bernal-Morell E, Martinez-Alvarez RM, Cabello-Clotet N, Tiraboschi J, Montero MDC, Vivancos-Gallego MJ, Diez C, Calderon R, De Zarraga MA, Gisbert L, Romero-Palacios A, Cabo R, Soler JF, Sepulveda MA, Sanchez-Guirao AJ, Escrich C, Arnaiz De Las Revillas F, Ferreira E, Valentin B, Lerida A, Llenas-Garcia J, Gomez A, Losa JE, Alonso B, Sanz J, Masia M, Pernas H, Corte JJ, Garcinuno MA, Gainzarain JC, Estebanez M, Garcia-Navarro MDM, Barragan P, Ramos N, Clavero M, Millan M, Del Alamo M, Egido M, De La Calle B, Ferrero OL, Troya J. A prospective assessment of the efficacy and durability of long-acting cabotegravir and rilpivirine in individuals with HIV in Spain (RELATIVITY study). J Antimicrob Chemother. 2025 Dec 2;80(12):3438-3451. doi: 10.1093/jac/dkaf389.
PubMed 41128149Orkin C, Bernal Morell E, Tan DHS, Katner H, Stellbrink HJ, Belonosova E, DeMoor R, Griffith S, Thiagarajah S, Van Solingen-Ristea R, Ford SL, Crauwels H, Patel P, Cutrell A, Smith KY, Vandermeulen K, Birmingham E, St Clair M, Spreen WR, D'Amico R. Initiation of long-acting cabotegravir plus rilpivirine as direct-to-injection or with an oral lead-in in adults with HIV-1 infection: week 124 results of the open-label phase 3 FLAIR study. Lancet HIV. 2021 Nov;8(11):e668-e678. doi: 10.1016/S2352-3018(21)00184-3. Epub 2021 Oct 14.
PubMed 34656207Cutrell AG, Schapiro JM, Perno CF, Kuritzkes DR, Quercia R, Patel P, Polli JW, Dorey D, Wang Y, Wu S, Van Eygen V, Crauwels H, Ford SL, Baker M, Talarico CL, Clair MS, Jeffrey J, White CT, Vanveggel S, Vandermeulen K, Margolis DA, Aboud M, Spreen WR, van Lunzen J. Exploring predictors of HIV-1 virologic failure to long-acting cabotegravir and rilpivirine: a multivariable analysis. AIDS. 2021 Jul 15;35(9):1333-1342. doi: 10.1097/QAD.0000000000002883.
PubMed 33730748Mughini-Gras L, Pijnacker R, Coipan C, Mulder AC, Fernandes Veludo A, de Rijk S, van Hoek AHAM, Buij R, Muskens G, Koene M, Veldman K, Duim B, van der Graaf-van Bloois L, van der Weijden C, Kuiling S, Verbruggen A, van der Giessen J, Opsteegh M, van der Voort M, Castelijn GAA, Schets FM, Blaak H, Wagenaar JA, Zomer AL, Franz E. Sources and transmission routes of campylobacteriosis: A combined analysis of genome and exposure data. J Infect. 2021 Feb;82(2):216-226. doi: 10.1016/j.jinf.2020.09.039. Epub 2020 Dec 1.
PubMed 33275955Tikkanen RS, Schneider EC. Social Spending to Improve Population Health - Does the United States Spend as Wisely as Other Countries? N Engl J Med. 2020 Mar 5;382(10):885-887. doi: 10.1056/NEJMp1916585. No abstract available.
PubMed 32130810Swindells S, Andrade-Villanueva JF, Richmond GJ, Rizzardini G, Baumgarten A, Masia M, Latiff G, Pokrovsky V, Bredeek F, Smith G, Cahn P, Kim YS, Ford SL, Talarico CL, Patel P, Chounta V, Crauwels H, Parys W, Vanveggel S, Mrus J, Huang J, Harrington CM, Hudson KJ, Margolis DA, Smith KY, Williams PE, Spreen WR. Long-Acting Cabotegravir and Rilpivirine for Maintenance of HIV-1 Suppression. N Engl J Med. 2020 Mar 19;382(12):1112-1123. doi: 10.1056/NEJMoa1904398. Epub 2020 Mar 4.
PubMed 32130809
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RETROSPECTIVE AND PROSPECTIVE MULTICENTER STUDY EVALUATING LONG TERM EFFECTIVENESS AND SAFETY OF CABOTEGRAVIR AND RILPIVIRINE IN REAL LIFE AS A LONG-ACTING TREATMENT IN PEOPLE LIVING WITH HIV AFTER ITS IMPLEMENTATION IN SPAIN. RELATIVITY COHORT
- ClinicalTrials.gov ID
- NCT07703748
- Acronym / sponsor ID
- FBIS-RELATIVITY
- Keywords
- Long-acting, cabotegravir, rilpivirine, CAB+RPV, Antiretroviral therapy, Real-world evidence, Observational cohort, Virological suppression
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,346 participants (actual)
- Lead sponsor
- FUNDACIÓN HOSPITAL UNIVERSITARIO INFANTA LEONOR Y DEL HOSPITAL UNIVERSITARIO DEL SURESTEUniversity, hospital or other
- Collaborators
- Hospital Universitario de Burgos
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 14 Jul 2026 (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.
The RELATIVITY study is a nationwide, multicenter, ambispective observational cohort evaluating the long-term effectiveness, safety, persistence, and tolerability of long-acting injectable cabotegravir plus rilpivirine (CAB+RPV LA) in people living with HIV in Spain.
The study includes adults with HIV-1 infection who achieved virological suppression on oral antiretroviral therapy and switched to long-acting CAB+RPV as part of routine clinical care. No study-specific treatment or interventions are performed. Clinical information is collected retrospectively from treatment initiation and prospectively during routine follow-up.
The primary objectives are to evaluate long-term virological effectiveness, treatment persistence, and confirmed virological failure over five years. Secondary objectives include assessment of safety, treatment discontinuation, adherence to injection schedules, immunological outcomes, metabolic changes, patient-reported outcomes, and factors associated with treatment success or failure. The study also evaluates outcomes in clinically relevant subgroups, including older adults, women, migrants, people with obesity, individuals with multimorbidity, and those infected through vertical transmission.
Detailed description
The RELATIVITY cohort is a national, multicenter, ambispective, non-interventional observational study designed to evaluate the long-term real-world effectiveness, safety, persistence, adherence, and tolerability of long-acting injectable cabotegravir plus rilpivirine (CAB+RPV LA) following its implementation into routine HIV care in Spain.
The study includes adults with HIV-1 infection who were virologically suppressed on oral antiretroviral therapy and switched to CAB+RPV LA according to routine clinical practice and approved prescribing information. Treatment decisions are entirely independent of study participation. No investigational intervention, randomization, or protocol-mandated treatment procedures are performed.
Participants receiving at least one injection of CAB+RPV LA between January 2023 and December 2024 are included through retrospective data collection, followed by prospective observation for up to five years after treatment initiation. Clinical data are collected from electronic medical records and entered into a centralized electronic case report form (eCRF). Follow-up reflects routine clinical practice at each participating center.
The primary study objectives are to evaluate:
Long-term maintenance of virological suppression. Treatment persistence. Time to confirmed virological failure.
Secondary objectives include evaluation of:
Safety and tolerability, including adverse events and injection-site reactions. Reasons for treatment discontinuation. Adherence to scheduled injection visits and oral bridging strategies. Virological rebounds and emergence of resistance-associated mutations. Immunological evolution (CD4 count, CD8 count, CD4/CD8 ratio). Changes in metabolic, renal, and hepatic parameters. Health-related quality of life and treatment satisfaction in a subset of participants.
Exploratory analyses will evaluate outcomes in clinically important subgroups, including older adults, women, migrants, individuals with obesity, multimorbidity, vertical HIV transmission, baseline resistance testing availability, and patients with previous adherence challenges to oral antiretroviral therapy.
Approximately 4,000 participants from 58 hospitals across Spain are expected to be included, making RELATIVITY one of the largest real-world cohorts evaluating long-acting injectable antiretroviral therapy. The study aims to generate robust evidence on the long-term use of CAB+RPV LA in routine clinical practice and to complement findings from randomized clinical trials by evaluating broader and more representative patient populations
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RELATIVITY | – | –Adults living with HIV-1 who achieved virological suppression on oral antiretroviral therapy and switched to long-acting intramuscular cabotegravir plus rilpivirine (CAB+RPV LA), administered every two months according to routine clinical practice and approved prescribing information in Spain. Participants are enrolled in a nationwide multicenter ambispective observational cohort and followed longitudinally to evaluate long-term effectiveness, treatment persistence, safety, adherence, tolerability, and virological outcomes. No study-specific intervention or treatment allocation is performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adults (≥18 years) living with HIV-1 receiving routine care in Spain who achieved virological suppression on oral antiretroviral therapy and switched to long-acting intramuscular cabotegravir plus rilpivirine (CAB+RPV LA) according to routine clinical practice. Participants are enrolled from 58 hospitals across Spain in a nationwide ambispective observational cohort. The study includes a broad and representative real-world population, including older adults, women, migrants, people with obesity, individuals with multimorbidity, and other clinically relevant subgroups. Approximately 4,000 participants are expected to be included and followed for up to 5 years after treatment initiation.
Key inclusion criteria (6 listed)
- Adults aged ≥18 years.
- Documented HIV-1 infection.
- Receiving oral antiretroviral therapy with plasma HIV-1 RNA <50 copies/mL at the time of switching to long-acting cabotegravir plus rilpivirine (CAB+RPV LA).
- No current or previous evidence of resistance to non-nucleoside reverse transcriptase inhibitors (NNRTIs) or integrase strand transfer inhibitors (INSTIs), and no previous virological failure with these drug classes.
- Received at least one injection of CAB+RPV LA before January 1, 2025.
Key exclusion criteria (4 listed)
- Any contraindication to CAB+RPV LA according to the approved product labeling.
- Previous exposure to long-acting CAB+RPV within an interventional clinical trial.
- Active hepatitis B infection (HBsAg positive).
- Pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of participants with HIV-1 RNA ≥50 copies/mL
Time frame: Month 12, Month 24, Month 36, Month 48, and Month 60
Proportion of participants with plasma HIV-1 RNA ≥50 copies/mL after initiation of long-acting cabotegravir plus rilpivirine, assessed according to the FDA Snapshot algorithm.
1 secondary outcome
Treatment persistence with CAB+RPV LA
Time frame: From baseline to Month 60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Background: PubMed 41128149Buzon-Martin L, Montes ML, Pedrero R, Galindo MJ, Santacreu-Guerrero M, Aleman MR, Torralba M, Diaz de Santiago A, Fanjul F, Rodriguez A, Cabello A, Crusells MJ, Navarro MDC, Aguilera M, Hidalgo-Tenorio C, Morano-Amado LE, Vinuesa D, De Andres C, Bernal-Morell E, Martinez-Alvarez RM, Cabello-Clotet N, Tiraboschi J, Montero MDC, Vivancos-Gallego MJ, Diez C, Calderon R, De Zarraga MA, Gisbert L, Romero-Palacios A, Cabo R, Soler JF, Sepulveda MA, Sanchez-Guirao AJ, Escrich C, Arnaiz De Las Revillas F, Ferreira E, Valentin B, Lerida A, Llenas-Garcia J, Gomez A, Losa JE, Alonso B, Sanz J, Masia M, Pernas H, Corte JJ, Garcinuno MA, Gainzarain JC, Estebanez M, Garcia-Navarro MDM, Barragan P, Ramos N, Clavero M, Millan M, Del Alamo M, Egido M, De La Calle B, Ferrero OL, Troya J. A prospective assessment of the efficacy and durability of long-acting cabotegravir and rilpivirine in individuals with HIV in Spain (RELATIVITY study). J Antimicrob Chemother. 2025 Dec 2;80(12):3438-3451. doi: 10.1093/jac/dkaf389.
- Background: PubMed 34656207Orkin C, Bernal Morell E, Tan DHS, Katner H, Stellbrink HJ, Belonosova E, DeMoor R, Griffith S, Thiagarajah S, Van Solingen-Ristea R, Ford SL, Crauwels H, Patel P, Cutrell A, Smith KY, Vandermeulen K, Birmingham E, St Clair M, Spreen WR, D'Amico R. Initiation of long-acting cabotegravir plus rilpivirine as direct-to-injection or with an oral lead-in in adults with HIV-1 infection: week 124 results of the open-label phase 3 FLAIR study. Lancet HIV. 2021 Nov;8(11):e668-e678. doi: 10.1016/S2352-3018(21)00184-3. Epub 2021 Oct 14.
- Background: PubMed 33730748Cutrell AG, Schapiro JM, Perno CF, Kuritzkes DR, Quercia R, Patel P, Polli JW, Dorey D, Wang Y, Wu S, Van Eygen V, Crauwels H, Ford SL, Baker M, Talarico CL, Clair MS, Jeffrey J, White CT, Vanveggel S, Vandermeulen K, Margolis DA, Aboud M, Spreen WR, van Lunzen J. Exploring predictors of HIV-1 virologic failure to long-acting cabotegravir and rilpivirine: a multivariable analysis. AIDS. 2021 Jul 15;35(9):1333-1342. doi: 10.1097/QAD.0000000000002883.
- Background: PubMed 33275955Mughini-Gras L, Pijnacker R, Coipan C, Mulder AC, Fernandes Veludo A, de Rijk S, van Hoek AHAM, Buij R, Muskens G, Koene M, Veldman K, Duim B, van der Graaf-van Bloois L, van der Weijden C, Kuiling S, Verbruggen A, van der Giessen J, Opsteegh M, van der Voort M, Castelijn GAA, Schets FM, Blaak H, Wagenaar JA, Zomer AL, Franz E. Sources and transmission routes of campylobacteriosis: A combined analysis of genome and exposure data. J Infect. 2021 Feb;82(2):216-226. doi: 10.1016/j.jinf.2020.09.039. Epub 2020 Dec 1.
- Background: PubMed 32130810Tikkanen RS, Schneider EC. Social Spending to Improve Population Health - Does the United States Spend as Wisely as Other Countries? N Engl J Med. 2020 Mar 5;382(10):885-887. doi: 10.1056/NEJMp1916585. No abstract available.
- Background: PubMed 32130809Swindells S, Andrade-Villanueva JF, Richmond GJ, Rizzardini G, Baumgarten A, Masia M, Latiff G, Pokrovsky V, Bredeek F, Smith G, Cahn P, Kim YS, Ford SL, Talarico CL, Patel P, Chounta V, Crauwels H, Parys W, Vanveggel S, Mrus J, Huang J, Harrington CM, Hudson KJ, Margolis DA, Smith KY, Williams PE, Spreen WR. Long-Acting Cabotegravir and Rilpivirine for Maintenance of HIV-1 Suppression. N Engl J Med. 2020 Mar 19;382(12):1112-1123. doi: 10.1056/NEJMoa1904398. Epub 2020 Mar 4.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results reported in publications derived from this study will be made available upon reasonable request to the corresponding author. Data sharing will be considered for scientifically sound research proposals after approval by the study steering committee, the sponsor, and the relevant ethics committees, when applicable. Data will be shared only after execution of an appropriate data sharing agreement and in compliance with applicable data protection regulations (including GDPR) and institutional policies.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus Infection (HIV) and HIV-1 Infection in Adults, run by FUNDACIÓN HOSPITAL UNIVERSITARIO INFANTA LEONOR Y DEL HOSPITAL UNIVERSITARIO DEL SURESTE 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 6 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: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 participants with HIV-1 RNA ≥50 copies/mL (time frame: Month 12, Month 24, Month 36, Month 48, and Month 60). 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 NCT07703748, which also lists 6 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 14 Jul 2026.