Phase 2
Completed N=195
A Study Of Different Doses Of UK-453, 061 Plus Truvada Compared To Efavirenz Plus Truvada In Patients Who Have Not Been Previously Treated For HIV-1
Source: ClinicalTrials.gov NCT00824421 ↗Enrolled (actual)
195
Serious AEs
9.8%
Results posted
Jan 2014
Primary outcomePrimary: Percentage of Participants With Less Than 50 Copies Per Milliliter (Copies/mL) of Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) at Week 48 — 78.5; 78.5; 85.7 percentage of participants
Summary
This is a 96 week study to determine if UK- 453,061 in combination with Truvada is as efficacious, safe and tolerable as efavirenz in combination with Truvada in HIV-1 infected patients who have not been previously treated with antiretroviral drugs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Less Than 50 Copies Per Milliliter (Copies/mL) of Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) at Week 48 |
78.5; 78.5; 85.7 | — |
| SECONDARY Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA at Week 24 and 96 |
83.1; 83.1; 87.3; 70.8; 67.7; 77.8 | — |
| SECONDARY Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA at Week 24, 48 and 96 |
84.6; 87.7; 90.5; 81.5; 80.0; 85.7 | — |
| SECONDARY Change From Baseline in Log 10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96 |
4.62; 4.69; 4.66; -2.44; -2.63; -2.68 | — |
| SECONDARY Time-Averaged Difference (TAD) in Log 10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96 |
-2.17; -2.30; -2.40; -2.23; -2.24; -2.39 | — |
| SECONDARY Percentage of Participants With Response as Determined Using the Time-to Loss of Virologic Response (TLOVR50) Algorithm at Week 24, 48 and 96 |
83.1; 83.1; 87.3; 78.5; 78.5; 85.7 | — |
| SECONDARY Change From Baseline in Cluster of Differentiation (CD4+) Absolute Cell Count at Week 24, 48 and 96 |
349; 352; 319; 146; 167; 139 | — |
| SECONDARY Change From Baseline in Cluster of Differentiation (CD4+) Percentage Cell Count at Week 24, 48 and 96 |
19.9; 20.0; 19.5; 6.0; 7.5; 7.3 | — |
| SECONDARY Number of Participants With NRTI and NNRTI Resistance-Associated Mutations (RAMs) at Time of Treatment Failure Through Week 24, 48 and 96 |
3; 0; 1; 3; 1; 1 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities |
59; 58; 57 | — |
| SECONDARY Population Pharmacokinetic (PK) of Lersivirine |
— | — |
| SECONDARY Lersivirine Success Percentage With Reference to Median Minimum Observed Plasma Concentration (Cmin) |
— | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Lersivirine |
6002; 8677 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Lersivirine |
1056; 1354 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of Lersivirine |
1.00; 2.00 | — |
| SECONDARY Plasma Concentration of Lersivirine at 24 Hour |
49.56; 57.70 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female at least 18 years of age available for a follow-up period of at least 96 weeks.
- HIV 1 RNA viral load of greater then 1,000 copies/mL
- Negative urine pregnancy test.
Exclusion Criteria
- Suspected or documented active, untreated HIV-1 related opportunist infection or other condition requiring acute therapy at the time of randomization.
- Subjects with acute Hepatitis B and/or C within 30 days of randomization.
- Absolute CD4 count <200 cells/mm3.
Data sourced from ClinicalTrials.gov (NCT00824421). 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.