Phase 3
Completed N=566
A Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA (0518-021 EXT)
Source: ClinicalTrials.gov NCT00369941 ↗Enrolled (actual)
566
Serious AEs
20.6%
Results posted
May 2010
Primary outcomePrimary: Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48 — 241; 230 Participants
Summary
This study will investigate the safety and efficacy of MK-0518 versus efavirenz, in combination with TRUVADA, as a therapy for Human Immunodeficiency Virus (HIV)-infected patients not previously treated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48 |
241; 230 | — |
| PRIMARY Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48 |
253; 272; 28; 10 | — |
| PRIMARY Number of Participants With Serious CAEs at Week 48 |
28; 27; 253; 255 | — |
| PRIMARY Number of Participants With Drug-related CAEs at Week 48 |
124; 217; 157; 65 | — |
| PRIMARY Number of Participants With Serious Drug-related CAEs at Week 48 |
4; 5; 277; 277 | — |
| PRIMARY Number of Participants That Died by Week 48 |
2; 0; 279; 282 | — |
| PRIMARY Number of Participants That Discontinued With CAEs at Week 48 |
9; 17; 272; 265 | — |
| PRIMARY Number of Participants That Discontinued With Serious CAEs at Week 48 |
7; 4; 274; 278 | — |
| PRIMARY Number of Participants That Discontinued With Drug-related CAEs at Week 48 |
3; 11; 278; 271 | — |
| PRIMARY Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48 |
1; 2; 280; 280 | — |
| PRIMARY Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48 |
27; 41; 254; 241 | — |
| PRIMARY Number of Participants With Serious LAEs at Week 48 |
0; 1; 281; 281 | — |
| PRIMARY Number of Participants With Drug-related LAEs at Week 48 |
14; 24; 267; 258 | — |
| PRIMARY Number of Participants With Serious Drug-related LAEs at Week 48 |
0; 0; 281; 282 | — |
| PRIMARY Number of Participants Discontinued With LAEs at Week 48 |
0; 1; 281; 281 | — |
| PRIMARY Number of Participants Discontinued With Drug-related LAEs at Week 48 |
0; 1; 281; 281 | — |
| SECONDARY Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48 |
252; 241 | — |
| SECONDARY Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48 |
189.1; 163.3 | — |
| SECONDARY Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96 |
228; 222 | — |
| SECONDARY Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96 |
240; 229 | — |
| SECONDARY Change From Baseline in CD4 Cell Count at Week 96 |
239.6; 224.8 | — |
| SECONDARY Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156 |
212; 192 | — |
| SECONDARY Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156 |
224; 203 | — |
| SECONDARY Change From Baseline in CD4 Cell Count at Week 156 |
331.7; 295.2 | — |
| SECONDARY Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240 |
198; 171 | — |
| SECONDARY Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240 |
206; 181 | — |
| SECONDARY Change From Baseline in CD4 Cell Count at Week 240 |
373.7; 311.6 | — |
| SECONDARY Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8 |
57; 147; 224; 135 | — |
| SECONDARY Number of Participants With CAEs at Week 96 |
265; 274; 16; 8 | — |
| SECONDARY Number of Participants With CAEs at Week 156 |
267; 276; 14; 6 | — |
| SECONDARY Number of Participants With CAEs at Week 240 |
271; 276; 10; 6 | — |
| SECONDARY Number of Participants With Serious CAEs at Week 96 |
37; 33; 244; 249 | — |
| SECONDARY Number of Participants With Serious CAEs at Week 156 |
46; 46; 235; 236 | — |
| SECONDARY Number of Participants With Serious CAEs at Week 240 |
57; 57; 224; 225 | — |
| SECONDARY Number of Participants With Drug-related CAEs at Week 96 |
132; 220; 149; 62 | — |
| SECONDARY Number of Participants With Drug-related CAEs at Week 156 |
139; 225; 142; 57 | — |
| SECONDARY Number of Participants With Drug-related CAEs at Week 240 |
146; 226; 135; 56 | — |
| SECONDARY Number of Participants With Serious Drug-related CAEs at Week 96 |
6; 5; 275; 277 | — |
| SECONDARY Number of Participants With Serious Drug-related CAEs at Week 156 |
6; 6; 275; 276 | — |
| SECONDARY Number of Participants With Serious Drug-related CAEs at Week 240 |
8; 7; 273; 275 | — |
| SECONDARY Number of Participants That Died by Week 96 |
3; 0; 278; 282 | — |
| SECONDARY Number of Participants That Died by Week 156 |
4; 1; 277; 281 | — |
| SECONDARY Number of Participants That Died by Week 240 |
5; 5; 276; 277 | — |
| SECONDARY Number of Participants That Discontinued With CAEs at Week 96 |
10; 17; 271; 265 | — |
| SECONDARY Number of Participants That Discontinued With CAEs at Week 156 |
13; 21; 268; 261 | — |
| SECONDARY Number of Participants That Discontinued With CAEs at Week 240 |
14; 25; 267; 257 | — |
| SECONDARY Number of Participants That Discontinued With Drug-related CAEs at Week 96 |
3; 12; 278; 270 | — |
| SECONDARY Number of Participants That Discontinued With Drug-related CAEs at Week 156 |
3; 14; 278; 268 | — |
| SECONDARY Number of Participants That Discontinued With Drug-related CAEs at Week 240 |
3; 14; 278; 268 | — |
| SECONDARY Number of Participants That Discontinued With Serious CAEs at Week 96 |
8; 5; 273; 277 | — |
| SECONDARY Number of Participants That Discontinued With Serious CAEs at Week 156 |
10; 6; 271; 276 | — |
| SECONDARY Number of Participants That Discontinued With Serious CAEs at Week 240 |
11; 10; 270; 272 | — |
| SECONDARY Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96 |
1; 2; 280; 280 | — |
| SECONDARY Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156 |
1; 2; 280; 280 | — |
| SECONDARY Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240 |
1; 2; 280; 280 | — |
| SECONDARY Number of Participants With LAEs at Week 96 |
33; 53; 248; 229 | — |
| SECONDARY Number of Participants With LAEs at Week 156 |
41; 63; 240; 219 | — |
| SECONDARY Number of Participants With LAEs at Week 240 |
56; 77; 225; 205 | — |
| SECONDARY Number of Participants With Drug-related LAEs at Week 96 |
18; 29; 263; 253 | — |
| SECONDARY Number of Participants With Drug-related LAEs at Week 156 |
22; 33; 259; 249 | — |
| SECONDARY Number of Participants With Drug-related LAEs at Week 240 |
26; 43; 255; 239 | — |
| SECONDARY Number of Participants With Serious LAEs at Week 96 |
0; 1; 281; 281 | — |
| SECONDARY Number of Participants With Serious LAEs at Week 156 |
0; 2; 281; 280 | — |
| SECONDARY Number of Participants With Serious LAEs at Week 240 |
0; 2; 281; 280 | — |
| SECONDARY Number of Participants With Serious Drug-related LAEs at Week 96 |
0; 0; 281; 282 | — |
| SECONDARY Number of Participants With Serious Drug-related LAEs at Week 156 |
0; 1; 281; 281 | — |
| SECONDARY Number of Participants With Serious Drug-related LAEs at Week 240 |
0; 1; 281; 281 | — |
| SECONDARY Number of Participants Discontinued With LAEs at Week 96 |
0; 2; 281; 280 | — |
| SECONDARY Number of Participants Discontinued With LAEs at Week 156 |
0; 3; 281; 279 | — |
| SECONDARY Number of Participants Discontinued With LAEs at Week 240 |
0; 3; 281; 279 | — |
| SECONDARY Number of Participants Discontinued With Drug-related LAEs at Week 96 |
0; 1; 281; 281 | — |
| SECONDARY Number of Participants Discontinued With Drug-related LAEs at Week 156 |
0; 2; 281; 280 | — |
| SECONDARY Number of Participants Discontinued With Drug-related LAEs at Week 240 |
0; 2; 281; 280 | — |
Eligibility Criteria
Inclusion Criteria
- Participant is a male or female at least 18 years of age
- Participant is HIV positive
- Participant is naïve to antiretroviral therapy (ART) and has not received any ART
Exclusion Criteria
- Participant has received approved or experimental antiretroviral agents in the past
- Participant has been treated for a viral infection other than HIV such as hepatitis B virus infection with an agent that is active against HIV including but not limited to adefovir or lamivudine (= 7 days total)
- Participant has documented resistance to tenofovir, emtricitabine, and/or efavirenz
- Participant has used another experimental HIV-integrase inhibitor
- Participant has a current (active) diagnosis of acute hepatitis due to any cause
- Participants with chronic hepatitis including chronic hepatitis B and/or C may enter the study as long as they have stable liver function tests
Data sourced from ClinicalTrials.gov (NCT00369941). 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.