N/A
Completed N=20
A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir
Source: ClinicalTrials.gov NCT03198884 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: Number of Participants With RNA <50 Copies/mL at 48 Weeks — 19 Participants — p=<0.05
Summary
A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With RNA <50 Copies/mL at 48 Weeks |
19 | <0.05 sig |
| PRIMARY The Change in Serum Creatinine From Baseline to 48 Weeks. |
73.4 | <0.05 sig |
| SECONDARY Change in Mean CD4+ Cell Count From Baseline. |
454; 428; 456 | — |
| SECONDARY Incidence of Adverse Events. |
6; 4; 3 | — |
| SECONDARY Number of Grade 1 Adverse Events Reported |
6; 4; 3 | — |
| SECONDARY Number of Participants With RNA <50 Copies/mL at 24, 36, and 48 Weeks |
19; 14; 19 | — |
| SECONDARY Analysis of Creatinine Clearance at Time Points 24, 36 and 48 Weeks. |
75.8; 69.1; 77.7 | — |
Eligibility Criteria
Inclusion Criteria
- ≥18 years old
- Received a regimen of darunavir 800 mg/ritonavir 100 mg in combination with dolutegravir 50 mg QD for ≥24 weeks as documented in EMR
- Laboratory reports (CD4, viral load, SrCr) available at time points +/- 4 6 weeks from 12, 24, 36, 48 weeks from start of regimen
- Resistance data (if applicable)
Exclusion Criteria
- Received a regimen of darunavir/ritonavir in combination with dolutegravir for <24 weeks duration
- Patients receiving darunavir/ritonavir + DTG+NRTI's
- Missing laboratory data in ≥2 study time points
- Patients missing more than five doses over two weeks prior study visit
Data sourced from ClinicalTrials.gov (NCT03198884). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.