Phase 2
Completed N=179
Safety and Efficacy of an Investigational Drug in Human Immunodeficiency Virus (HIV)-Infected Patients Failing Current Antiretroviral Therapies (0518-005)(COMPLETED)
HIV Infections · Acquired Immunodeficiency Syndrome
Source: ClinicalTrials.gov NCT00105157 ↗
Enrolled (actual)
179
Serious AEs
17.4%
Results posted
Apr 2010
Primary outcomePrimary: Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24 — -1.80; -1.87; -1.84; -0.35 HIV RNA (log10 copies/mL)
Summary
This study will investigate the safety and efficacy of different doses of an investigational drug (MK0518) as a therapy for HIV-infected patients failing current antiretroviral therapies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24 |
-1.80; -1.87; -1.84; -0.35 | — |
| SECONDARY Number of Patients With Virologic Responses at Week 24 |
30; 32; 32; 7; 28; 25 | — |
| SECONDARY Change From Baseline in CD4 Cell Count at Week 24 |
62.9; 112.8; 94.1; 5.4 | — |
| SECONDARY Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks |
37; 37; 41; 37; 6; 8 | — |
| SECONDARY Number of Patients With Serious CAEs at 48 Weeks |
3; 7; 4; 3; 40; 38 | — |
| SECONDARY Number of Patients With Drug-related CAEs at 48 Weeks |
18; 19; 24; 24; 25; 26 | — |
| SECONDARY Number of Patients With Serious Drug-related CAEs at 48 Weeks |
1; 0; 1; 2; 42; 45 | — |
| SECONDARY Number of Patients That Died by 48 Weeks |
1; 0; 1; 0; 42; 45 | — |
| SECONDARY Number of Patients That Discontinued With CAEs at 48 Weeks |
1; 0; 1; 1; 42; 45 | — |
| SECONDARY Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks |
0; 0; 0; 1; 43; 45 | — |
| SECONDARY Number of Patients That Discontinued With Serious CAEs at 48 Weeks |
1; 0; 1; 1; 42; 45 | — |
| SECONDARY Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks |
0; 0; 0; 1; 43; 45 | — |
| SECONDARY Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks |
10; 12; 14; 11; 33; 33 | — |
| SECONDARY Number of Patients With Drug-related LAEs at 48 Weeks |
7; 8; 7; 8; 36; 37 | — |
| SECONDARY Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks |
1; 0; 0; 0; 42; 45 | — |
| SECONDARY Number of Patients Discontinued With Drug-related LAEs at 48 Weeks |
1; 0; 0; 0; 42; 45 | — |
| SECONDARY Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks |
43; 42; 45; 38; 0; 3 | — |
| SECONDARY Number of Patients With Serious CAEs at 96 Weeks |
4; 9; 5; 3; 39; 36 | — |
| SECONDARY Number of Patients With Drug-related CAEs at 96 Weeks |
24; 25; 28; 26; 19; 20 | — |
| SECONDARY Number of Patients With Serious Drug-related CAEs at 96 Weeks |
1; 0; 1; 2; 42; 45 | — |
| SECONDARY Number of Patients That Died by 96 Weeks |
2; 1; 1; 0; 41; 44 | — |
| SECONDARY Number of Patients That Discontinued With CAEs at 96 Weeks |
2; 1; 1; 1; 41; 44 | — |
| SECONDARY Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks |
0; 0; 0; 1; 43; 45 | — |
| SECONDARY Number of Patients That Discontinued With Serious CAEs at 96 Weeks |
2; 1; 1; 1; 41; 44 | — |
| SECONDARY Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks |
0; 0; 0; 1; 43; 45 | — |
| SECONDARY Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks |
12; 15; 17; 12; 31; 30 | — |
| SECONDARY Number of Patients With Drug-related LAEs at 96 Weeks |
9; 9; 11; 8; 34; 36 | — |
| SECONDARY Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks |
1; 1; 0; 0; 42; 44 | — |
| SECONDARY Number of Patients Discontinued With Drug-related LAEs at 96 Weeks |
1; 1; 0; 0; 42; 44 | — |
| SECONDARY Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks |
43; 43; 45; 38; 0; 2 | — |
| SECONDARY Number of Patients With Serious CAEs at 168 Weeks |
6; 13; 7; 3; 37; 32 | — |
| SECONDARY Number of Patients With Drug-related CAEs at 168 Weeks |
27; 27; 30; 26; 16; 18 | — |
| SECONDARY Number of Patients With Serious Drug-related CAEs at 168 Weeks |
2; 0; 2; 2; 41; 45 | — |
| SECONDARY Number of Patients That Died by 168 Weeks |
3; 1; 1; 0; 40; 44 | — |
| SECONDARY Number of Patients That Discontinued With CAEs at 168 Weeks |
3; 1; 1; 1; 40; 44 | — |
| SECONDARY Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks |
0; 0; 0; 1; 43; 45 | — |
| SECONDARY Number of Patients That Discontinued With Serious CAEs at 168 Weeks |
3; 1; 1; 1; 40; 44 | — |
| SECONDARY Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks |
0; 0; 0; 1; 43; 45 | — |
| SECONDARY Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks |
17; 16; 18; 12; 26; 29 | — |
| SECONDARY Number of Patients With Serious LAEs at 168 Weeks |
1; 0; 1; 0; 42; 45 | — |
| SECONDARY Number of Patients Discontinued With Drug-related LAEs at 168 Weeks |
2; 0; 0; 0; 41; 45 | — |
| SECONDARY Number of Patients With Drug-related LAEs at 168 Weeks |
13; 10; 11; 9; 30; 35 | — |
| SECONDARY Number of Patients With Serious Drug-related LAEs at 168 Weeks |
1; 0; 1; 0; 42; 45 | — |
| SECONDARY Number of Patients Discontinued With LAEs at 168 Weeks |
2; 0; 0; 0; 41; 45 | — |
Eligibility Criteria
Inclusion Criteria
- Patient must be HIV positive with Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) values that are within ranges required by the study
- Patient must be currently on antiretroviral therapy (ART)
Exclusion Criteria
- Patient less than 18 years of age
- Additional exclusion criteria will be discussed and identified by the study doctor
Data sourced from ClinicalTrials.gov (NCT00105157). 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.