An observational study in Quality of Life, sponsored by University Paris 7 - Denis Diderot. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by University Paris 7 - Denis Diderot · Observational
Context The introduction of the long-acting injectable antiretroviral treatment cabotegravir and rilpivirine into the therapeutic armamentarium for people living with HIV represents a potentially significant evolution in patients' experience of their treatment and pathology. Its effects on the quality of life of PLHIV are explored in this research. In addition, the two-monthly intra-muscular injection regimen also raises questions about the city-to-hospital transition of care for PLHIV, as well as compliance with the therapeutic window.
Main objective To evaluate the effect of switching HIV treatment to CAB+RPV LA on health-related quality of life on the "Treatment Impact" dimension of the PROQOL-HIV questionnaire, 15 months after switching treatment.
Population People living with HIV-1 whose ARV treatment has been changed to an injectable CAB+RPV LA treatment
Study Design Observational study. Inclusion at HIV medical follow-up visit for change of ARV treatment to CAB/RPV.
Self-administered questionnaires at M3, M9 and M15 after change of treatment (first CAB/RPV injection).
University Paris 7 - Denis Diderot is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
People living with HIV-1 whose ARV treatment has been changed to an injectable CAB+RPV LA treatment
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
People living with HIV-1
Drug: Cabotegravir, Rilpivirine Drug Combination
Treatment switch to CAB+RPV LA
Treatment Impact - PROQOL-HIV
Evolution of the score of the "Treatment impact (TI)" dimension of the PROQOL-HIV questionnaire (10 items)
Time frame: between D0 (baseline) and 15 months after the first injection of CAB+RPV LA
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2024; primary completion for Apr 2026, 23 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University Paris 7 - Denis Diderot