A Phase 2 interventional study of Dolutegravir + Darunavir/ritonavir + optimized NRTI in HIV/AIDS, sponsored by ANRS, Emerging Infectious Diseases. Status unknown at 1 site in Cambodia. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2021-08-26.
Sponsored by ANRS, Emerging Infectious Diseases · Phase 2, Interventional, and Treatment
The study aims to evaluate the virological effectiveness of a third-line regimen combining dolutegravir (DTG), ritonavir-boosted darunavir (DRV/r) and optimized NRTI in Cambodian HIV-infected adults, who failed a protease inhibitors (PI)-based second-line regimen despite 3 months of boosted adherence counseling (BAC).
Each patient will be informed of the objectives and the total duration of the study as well as the benefits and risks to participate. After signature of consent form, Genotyping Resistance Test (GRT) and pre-inclusion samples will be done for all patients with HIV RNA > 1000 copies/mL after 3 months of boosted adherence counselling (BAC). After receiving results of the GRT and the pre-inclusion sample, the technical working group (TWG) of HIV national program will decide to switch the patient to third-line regimen or to continue second-line regimen with new BAC.
PI-based second-line regimen will be continue if 1/ GRT shows sensitivity to ATV 2/ GRT shows sensitivity to at least one of the 3 NRTI recommended in Cambodia (AZT, ABC and TDF). In that case, adherence counselling will be boosted according to the new national guidance and the patient will not be enrolled in the study.
In case of intermediate or fully resistance to ATV/r OR sensitivity to ATV but both resistances to AZT, ABC and TDF and after confirmation of eligibility criteria, patient could be enrolled in the study. A third-line regimen will be started including DRV/r 600/100 twice daily + DTG 50 mg once daily + 3TC 300 mg once daily +/- one fully or intermediate sensitive NRTI among TDF, ABC and AZT. The choice of the last NRTI will be discussed and decided by the TWG according to the HBsAg status, to the result of the GRT and to the medical history of the patient.
At 6 months, plasma HIV-1 RNA will be measured:
For all patients, a new virological assessment will be done at 9 and 12 months.
DRV and DTG exposure and pharmacokinetic parameters (Cmax, Cmin and AUC) will be estimated for the 20 first enrolled patients, allowing an intra-patient comparison of the 2 dosing regimens of DRV/r for at least 15 patients.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's planned enrollment of 54 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →ANRS, Emerging Infectious Diseases is the lead sponsor of 212 studies on the registry; 40 are open to participants now.
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Exclusion Criteria:
All patients will receive ART regimen every day including: Dolutegravir 50mg once daily Darunavir/ritonavir 600/100 twice daily Optimized NRTI recycling with lamivudine and one other NRTI (zidovudine or tenofovir or abacavir)
Drug: Dolutegravir + Darunavir/ritonavir + optimized NRTI
Dolutegravir 50mg once daily Darunavir/ritonavir 600/100 twice daily Optimized NRTI recycling with lamivudine and one other NRTI (zidovudine or tenofovir or abacavir)
Virological effectiveness at 6 months
Proportion of patients with plasma HIV-1 RNA \< 40 copies/mL by FDA Snapshot analysis
Time frame: Month 6
Virological effectiveness at 12 months
Proportion of patients with plasma HIV-1 RNA \< 40 copies/mL by FDA Snapshot analysis at 12 months
Time frame: Month 12
Incidence of adverse events (safety)
Incidence of grade 3-4 adverse events (ANRS grading table)
Time frame: Month 12
Tolerance
Proportion of patients with permanent study treatment discontinuation during the first year
Time frame: Month 12
Adherence to treatment strategy
Proportion of patients with adherence \> 90%
Time frame: Month 12
Plasmatic drug concentrations
Plasmatic dolutegravir concentrations
Time frame: Month 1
Plasmatic drug concentrations
Plasmatic darunavir concentrations
Time frame: Month 1
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome→
ANRS, Emerging Infectious Diseases