A Phase 4 interventional study of Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY] in HIV Infections, sponsored by Fundacion SEIMC-GESIDA. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Fundacion SEIMC-GESIDA · Phase 4, Interventional, and Health services research
Implementation of a model for access and retention of HIV care for vulnerable and excluded population using a mobile screening unit and a strategy of diagnosis and initiation of treatment with Bictegravir (BIC) 50 mg/ Emtricitabine (FTC) 200 mg / Tenofovir Alafenamide (TAF) 25 mg.
The use of a mobile unit to reach vulnerable HIV-infected people with poor access to the health care system and starting/restarting on the same day ("simplified same day test and treat strategy") is feasible, effective and safe and will allow these people to have a rapid access to ART and long-term follow-up and health care for HIV.
At the screening visit the patient will sign the informed consent form, revise the clinical history and ensure compliance with criteria. A history of drug abuse, complete physical examination, pregnancy test, rapid hepatitis C test, questionnaires and social situation will be collected from the patient.
At the basal visit the patients enrolled in the study will collect lab test (blood count, biochemistry, coagulation, serology, inmunology and virology), vital signs and directed physical examination, concomitant medication and adverse events.
After the basal visit the patient will be followed up on visits week 4, 12, 24, 48 and last visit 50 as follow up safety visit.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 101 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Fundacion SEIMC-GESIDA is the lead sponsor of 30 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patient enrolled in the study and access HIV consulting will start treatment with BIKTARVY the same day of the inclusion. The medication will provided by the sponsor and it will be dispensed by pharmacy service. The delivery of medication to the patient can be delegated by a member of investigator staff who pick up the mediaction from pharmacy service to be delivered to the patient. The patient can pick up the medication directly from the pharmacy service. It will be recorded the face to face on delegated dispensing. The deliver of medication will be bi-monthly and 2 bottles of tablets will be dispensed. The patients will receive a BIC/FTC/TAF single oral dose per day for 12 months.
Drug: Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY]
Patients enrolled in the study and accessing the HIV consultation will start treatment with BIKTARVY on the day of enrollment. Medication will be provided by the sponsor and dispensed through the pharmacy service. The drug will be delivered to the patient with a delegated person outside the hospital environment or it will be the patient himself who picks up the medication.
To Find Out Whether the Implementation of a Model of Access and Retention in Care for HIV Among Vulnerable People Using a Mobile Screening Unit and a Same-day Diagnosis and Treatment Initiation Strategy is Effective and Safety.
Proportion of subjects making visits at weeks 24 and 48.
Time frame: 24-48 weeks
To Assess the Implementation and Feasibility of the Intervention
Proportion of participants with HIV viral load \<50 copies/ml throughout the study
Time frame: Baseline, week 4, week 12, week 24 and week 48
| Milestone | Patients Received BIKTARVY (BIC/FTC/TAF) |
|---|---|
| Started | 101 |
| Completed | 89 |
| Not completed | 12 |
| Withdrew: Lost to follow-up | 4 |
| Withdrew: Change of patient's residence | 4 |
| Withdrew: Non-compliance with treatment or study visits | 2 |
| Withdrew: Imprisonment | 2 |
| Milestone | Patients Received BIKTARVY (BIC/FTC/TAF) |
|---|---|
| Started | 89 |
| Completed | 80 |
| Not completed | 9 |
| Withdrew: Lost to follow-up | 6 |
| Withdrew: Non-compliance with treatment or study visits | 1 |
| Withdrew: Change of patient's residence | 1 |
| Withdrew: Death | 1 |
| Milestone | Patients Received BIKTARVY (BIC/FTC/TAF) |
|---|---|
| Started | 80 |
| Completed | 79 |
| Not completed | 1 |
| Withdrew: Imprisonment | 1 |
| Milestone | Patients Received BIKTARVY (BIC/FTC/TAF) |
|---|---|
| Started | 79 |
| Completed | 65 |
| Not completed | 14 |
| Withdrew: Lost to follow-up | 10 |
| Withdrew: Non-compliance with treatment or study visits | 1 |
| Withdrew: Imprisonment | 2 |
| Withdrew: Change of patient's residence | 1 |
Proportion of subjects making visits at weeks 24 and 48.
| Participants | Patients Received BIKTARVY (BIC/FTC/TAF) |
|---|---|
| Complete the follow-up at week 48 | 65 (6.6 to 50.2) |
| Don´t complete the follow-up at week 48 | 36 |
| Complete the follow-up at week 24 | 79 |
| Don´t complete the follow-up at week 24 | 22 |
Proportion of participants with HIV viral load \<50 copies/ml throughout the study
| Participants | Patients Received BIKTARVY (BIC/FTC/TAF) |
|---|---|
| Baseline visit — VL < 50 copies/mL | 13 |
| Baseline visit — VL >= 50 copies/mL | 88 |
| Baseline visit — Not available | 0 |
| Baseline visit — Withdrawal | 0 |
| Week 4 — VL < 50 copies/mL | 62 |
| Week 4 — VL >= 50 copies/mL | 22 |
| Week 4 — Not available | 5 |
| Week 4 — Withdrawal | 12 |
| Week 12 — VL < 50 copies/mL | 73 |
| Week 12 — VL >= 50 copies/mL | 3 |
| Week 12 — Not available | 4 |
| Week 12 — Withdrawal | 21 |
| Week 24 — VL < 50 copies/mL | 71 |
| Week 24 — VL >= 50 copies/mL | 7 |
| Week 24 — Not available | 1 |
| Week 24 — Withdrawal | 22 |
| Week 48 — VL < 50 copies/mL | 62 |
| Week 48 — VL >= 50 copies/mL | 2 |
| Week 48 — Not available | 1 |
| Week 48 — Withdrawal | 36 |
Collected over Each patient was evaluated from the signing of the informed consent form until the last visit, an average of 48 weeks. The evaluation of all patients was carried out over a period of approximately 2 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients Received BIKTARVY (BIC/FTC/TAF) | 1/101 (1%) | 4/101 (4%) | 0/101 (0%) |
| Event | Patients Received BIKTARVY (BIC/FTC/TAF) |
|---|---|
| PneumoniaInfections and infestations | 1/101 |
| Autolytic attempPsychiatric disorders | 1/101 |
| Metastasis of pancreatic tumorNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/101 |
| Submental massMusculoskeletal and connective tissue disorders | 1/101 |
| Age, Continuous(years) | Patients Received BIKTARVY (BIC/FTC/TAF) |
|---|---|
| Mean | 36.4 ± 10.7 |
| Sex: Female, Male(Participants) | Patients Received BIKTARVY (BIC/FTC/TAF) |
|---|---|
| Female | 14 |
| Male | 87 |
| Race/Ethnicity, Customized(Participants) | Patients Received BIKTARVY (BIC/FTC/TAF) |
|---|---|
| Race categories — Caucasian | 26 |
| Race categories — Hispanic | 74 |
| Race categories — Other | 1 |
| Region of Enrollment(Participants) | Patients Received BIKTARVY (BIC/FTC/TAF) |
|---|---|
| Spain | 101 |
| Born in Spain(Participants) | Patients Received BIKTARVY (BIC/FTC/TAF) |
|---|---|
| Yes | 22 |
| No | 79 |
| Educational level(Participants) | Patients Received BIKTARVY (BIC/FTC/TAF) |
|---|---|
| Incomplete primary education | 5 |
| Complete primary education | 12 |
| Complete secondary education | 64 |
| Completed university studies | 14 |
| Unknown | 6 |
| Orientation of desire(Participants) | Patients Received BIKTARVY (BIC/FTC/TAF) |
|---|---|
| Homosexual | 57 |
| Heterosexual | 36 |
| Bisexual | 5 |
| Others | 1 |
| Unknown | 2 |
| Social support network(Participants) | Patients Received BIKTARVY (BIC/FTC/TAF) |
|---|---|
| Family | 16 |
| Friends | 17 |
| None | 68 |
19 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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