Phase 2
Completed N=86
Effects of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppressed Participants (MK-1439A-028)
HIV · Central Nervous System
Source: ClinicalTrials.gov NCT02652260 ↗
Enrolled (actual)
86
Serious AEs
4.7%
Results posted
Aug 2019
Primary outcomePrimary: Percentage of Participants With at Least One Central Nervous System (CNS) Toxicity of at Least Grade 2 Intensity at Week 12 — 41.9; 37.2 Percentage of participants — p=0.331
Summary
This study aims to evaluate a switch from fixed dose combination (FDC) treatment with ATRIPLA^TM for 12 weeks prior to screening to FDC treatment with Doravirine, Tenofovir, Lamivudine (MK-1439A) in virologically-suppressed, human immunodeficiency virus type 1 (HIV-1)-infected participants. The primary hypothesis is that switching from ATRIPLA^TM to Doravirine, Tenofovir, Lamivudine results in a lower proportion of participants with at least one CNS toxicity of at least Grade 2 intensity at Week 12 than continuation of ATRIPLA^TM treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least One Central Nervous System (CNS) Toxicity of at Least Grade 2 Intensity at Week 12 |
41.9; 37.2 | 0.331 |
| SECONDARY Percentage of Participants With at Least One CNS Toxicity of at Least Grade 2 Intensity at Week 4 |
46.5; 65.1 | — |
| SECONDARY Change From Baseline in CNS Toxicity Score at Week 4 |
-17.6; -15.6 | — |
| SECONDARY Change From Baseline in CNS Toxicity Score at Week 12 |
-18.1; -21.7 | — |
| SECONDARY Percentage of Participants With at Least One CNS Toxicity of at Least Grade 2 Intensity at Time of Switch, and at 24 Weeks Post-switch for the Combined Treatment Groups |
68.6; 30.2 | — |
| SECONDARY CNS Toxicity Scores at Time of Switch, and at 24 Weeks Post-switch for the Combined Treatment Groups |
24.2; 10.7 | — |
| SECONDARY Change From Baseline in Fasting Lipids at Week 12 |
-10.78; -1.88; -14.08; -0.37; -22.14; 0.00 | — |
| SECONDARY Change in Fasting Lipids Between Time of Switch and Week 24 Post-switch for the Combined Treatment Groups |
-10.97; -13.18; -20.91; -7.72; -12.99 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA <50 and <40 Copies/ml at Week 24 Post-switch for the Combined Treatment Groups |
95.3; 95.3 | — |
| SECONDARY Change From Time of Switch to Week 24 Post Switch in CD4 T-cell Count for the Combined Treatment Groups |
70.4 | — |
| SECONDARY Number of Participants With One or More Adverse Events (AEs) Through Study Week 12 |
34; 34 | — |
| SECONDARY Number of Participants With One or More Drug-related AEs Through Study Week 12 |
14; 9 | — |
| SECONDARY Number of Participants With One or More Serious Adverse Events (SAEs) Through Study Week 12 |
0; 0 | — |
| SECONDARY Number of Participants With One or More Drug-related SAEs Through Study Week 12 |
0; 0 | — |
| SECONDARY Number of Participants Who Discontinued Treatment Due to an AE Through Study Week 12 |
0; 0 | — |
| SECONDARY Number of Participants With One or More AEs for the Combined Treatment Groups 24 Weeks After the Switch |
71 | — |
| SECONDARY Number of Participants With One or More Drug-related AEs for the Combined Treatment Groups 24 Weeks After the Switch |
18 | — |
| SECONDARY Number of Participants With One or More SAEs for the Combined Treatment Groups 24 Weeks After the Switch |
1 | — |
| SECONDARY Number of Participants With One or More Drug-related SAEs for the Combined Treatment Groups 24 Weeks After the Switch |
— | — |
| SECONDARY Number of Participants Who Discontinued Treatment Due to an AE for the Combined Treatment Groups 24 Weeks After the Switch |
— | — |
Eligibility Criteria
Inclusion Criteria
- is taking ATRIPLA™, generic versions of ATRIPLA™, or the components of ATRIPLA™ (EFV,TDF plus emtricitabine),
- has documentation of HIV-1 ribonucleic acid (RNA) 9.
- is pregnant, breastfeeding, or expecting to conceive.
- female is expecting to donate eggs (at any time during the study) or male is expecting to donate sperm (at any time during the study).
Data sourced from ClinicalTrials.gov (NCT02652260). 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.