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Study identifier: NCT04513626 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

HIV-1 Infected Patients, Phase II Trial, Dual Combination Doravirine/Raltegravir Open Label

Condition: HIV Infections  ·  Sponsor: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida

PhasePhase 2
Planned participants150
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

The objective of antiretroviral therapy (ART) is the maintenance of HIV viral suppression, the optimal condition to prevent disease progression, to optimize immune restoration, to prevent the development of viral resistance and to reduce viral transmission. Antiretroviral therapy has to be maintained long life over decades in the absence of strategies for HIV cure. This is why the long-term cumulative toxicity of ARV drugs is a major issue. Indeed as a consequence of potent ART strategies, in 2011 over 88% of patients on ART in the French Hospital database (ANRS CO4 FHDH) achieved viral suppression with HIV-RNA plasma viral load \< 50 copies/mL and nearly 60% had CD4 \> 500/mm3. As a consequence of massive reduction of mortality and morbidity related to HIV, infected patients are aging with 40% of patients over 50 years of age in the ANRS CO4 FHDH. The current standard-of-care for antiretroviral therapy consists in a triple drug combination with two nucleoside reverse transcriptase inhibitors (NRTIs) plus either a non-nucleoside reverse transcriptase inhibitor (NNRTI), a protease inhibitor (PI), or an integrase inhibitor (INSTI). NRTIs and PIs have been associated to cumulative long-term toxicity such as bone and renal disorders related to tenofovir and increased cardio-vascular risk with PIs. In general population, aging is associated with well-known comorbidities such as bone demineralization, increased incidence of cardio or cerebrovascular disease, diabetes, renal dysfun…

This description comes directly from the study's public registry record.

Talk to the study team

Yasmine Dudoit  ·  33142164181  ·  yasmine.dudoit@aphp.fr

Christine Katlama, MD  ·  33142160142  ·  christine.katlama@aphp.fr

Always discuss trial participation with your own doctor first.

Locations (1)

Christine KATLAMAParis, Île-de-France Region, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT04513626