ClinicalTrials.gg
CompletedNCT03348449BIRDiUpdated Jul 2, 2018

Bitherapy With the Combination of Raltegravir and Darunavir (BIRDi)

An observational study in Comorbidities and HIV/AIDS, sponsored by Asociacion para el Estudio de las Enfermedades Infecciosas. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-02.

Sponsored by Asociacion para el Estudio de las Enfermedades Infecciosas · Observational

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
360
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 96 studies in Acquired Immunodeficiency Syndrome with a site in Spain — 6 open to participants now, 13 under way, 3 of them phase 3. Acquired Immunodeficiency Syndrome · Spain.

Enrollment
8th of 17
360 · median 355
Started
2017
the only one that year
Observational
17 of 96
1 open now
Registered
67th of 96
by date

Among the 96 studies in Acquired Immunodeficiency Syndrome with a site in Spain, this one is the 8th largest by enrollment of the 17 observational ones that give a count, is the only one that started in 2017, is one of 17 observational ones, and was the 67th registered.

Acquired Immunodeficiency Syndrome

3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.

Browse Acquired Immunodeficiency Syndrome studies →

Open to participants now

6 of the 96 studies in Acquired Immunodeficiency Syndrome with a site in Spain are open now. Recruiting first, the newest first:

1 more — sign in →

All 6 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 96 studies in Acquired Immunodeficiency Syndrome with a site in Spain, or all of them as a file.
02

Study summary

Retrospective cohort of virologically suppressed HIV-infected patients who received the combination of Raltegravir plus Darunavir boosted with cobicistat or ritonavir, as dual therapy, because or toxicity or intolerance to nucleoside analogues

Read the detailed description

This is a retrospective cohort study including those HIV-infected patients who received the combination of raltegravir plus darunavir boosted with cobicistat or ritonavir as dual therapy, due to the existence of toxicity or intolerance to nucleoside analogues, to evaluate:

  • efficacy, measured as percentage of patients free of virological failure after 48 and 96 weeks (ITT-e, snapchot analysis) and improvement in CD4+ count
  • tolerance (rate of discontinuation and cause, and frequency of adverse events)
  • evolution of different comorbidities (renal, bone, cardiovascular events)

Patients will included if they have received at least 1 dose of the dual therapy

03

Conditions studied

  • Comorbidities
  • HIV/AIDS

Keywords

  • HIV
  • Dual therapy
  • Comorbidities
  • Nucleoside analogues sparing-regimens
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

HIV infected patients with virological suppression but toxicity or intolerance to analogues who switched to the combination of Raltegravir plus boosted Darunavir

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.

Inclusion criteria

  • infection
  • Older than 18 years
  • To have received the combination of raltegravir plus boosted darunavir in patients with virological suppression (more than 6 months) after toxicity or intolerance to nucleoside analogues

Exclusion criteria

Exclusion Criteria:

  • Virological failure in the last 6 months previous to dual therapy
  • Presence or suspicion of resistance to Darunavir (major mutations according to Meyer et al) or to Raltegravir (major mutations according to IAS list)
  • Active
Terms in these criteria, in plain language(2)

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.

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.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
360 participants (actual)
Patient registry
No

Interventions

  • OtherCollection of data

    Outcome of patients will be collected from charts to evaluate primary and secondary objectives

06

What researchers measure

Primary outcomes

  1. Percentage of patients who maintained virological suppression on treatment at 48 weeks after using this dual therapy

    The number of patients who remained with virological suppression during the study at 48 weeks (ITT-exposed, snapchot analysis)

    Time frame: 48 weeks

Secondary outcomes

  1. Change in renal parameters at 48 weeks,for patients using dual therapy

    Evaluation of renal parameters in patients changing to this dual therapy, considering the previous use of TDF or not.

    Time frame: 48 weeks

  2. Change in bone parameters (bone mineral density by Dual X-ray absorptiometry) during the study

    Quantitative changes in bone mineral density (BMD) according to previous use of TDF and renal parameters

    Time frame: 48 weeks

  3. Change in cardiovascular risk (by using AHA score) for patients using dual therapy

    Changes in lipid parameters will be assessed

    Time frame: 48 weeks

  4. Changes in inflammatory markers during the study, measured by the CD4/CD8 ratio

    Those patients who received this dual therapy will be evaluated to determine changes in inflammatory biomarkers such as CD4/CD8 ratio

    Time frame: 48 weeks

07

Study locations

1 site
  • Ramon y Cajal Hospital
    Madrid, 28034, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2017 to primary completion in Jun 2018, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 13, 2017
First posted
Nov 20, 2017
StartActual
Dec 15, 2017
Primary completionActual
Jun 15, 2018
CompletionActual
Jun 29, 2018
Last update
Jul 2, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03348449
Lead sponsor
Asociacion para el Estudio de las Enfermedades Infecciosas
Responsible party
Jose L. Casado (Physician, Asociacion para el Estudio de las Enfermedades Infecciosas) — Principal investigator
First posted
Nov 20, 2017
Start date
Dec 15, 2017
Primary completion
Jun 15, 2018
Completion
Jun 29, 2018
Last update
Jul 2, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion