Phase 2
Completed N=35
A Study to Evaluate the Safety and Efficacy of an Investigational Drug in HIV Infected Patients (0518-004)(COMPLETED)
HIV Infections · Acquired Immunodeficiency Syndrome
Source: ClinicalTrials.gov NCT00100048 ↗
Enrolled (actual)
35
Serious AEs
14.6%
Results posted
Mar 2010
Primary outcomePrimary: Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I) — -1.93; -1.98; -1.66; -2.16 copies/mL
Summary
This is a study that will investigate the safety and efficacy of an investigational drug in Human immunodeficiency virus (HIV) infected patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I) |
-1.93; -1.98; -1.66; -2.16; -0.17 | — |
| PRIMARY Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) |
4; 2; 3; 5; 5; 3 | — |
| PRIMARY Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II) |
31; 27; 35; 32; 32 | — |
| PRIMARY Number of Patients With Clinical Adverse Experiences (CAEs) |
31; 35; 36; 35; 34; 8 | — |
| PRIMARY Number of Patients With Serious CAEs (Cohort I and II Combined) |
2; 5; 0; 2; 2; 37 | — |
| PRIMARY Number of Patients With Serious CAEs and Non-serious CAEs at Week 144 |
153; 35; 7; 3; 18; 4 | — |
| PRIMARY Number of Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs) |
154; 35; 25; 4 | — |
| PRIMARY Number of Participants With HIV RNA (Human Immunodeficiency Virus Ribonucleic Acid) Levels Below 50 Copies/mL at Week 240 |
110; 24 | — |
| SECONDARY Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II) |
28; 27; 33; 32; 31 | — |
| SECONDARY Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II) |
-2.39; -2.20; -2.33; -2.49; -2.44 | — |
| SECONDARY Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II) |
184; 122; 147; 134; 101 | — |
| SECONDARY Number of Patients With HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96 |
133; 32; 135; 32 | — |
| SECONDARY Change From Baseline in Plasma HIV RNA at Week 96 |
-2.30; -2.28 | — |
| SECONDARY Change From Baseline in CD4 Cell Count at Week 96 |
221.2; 232.4 | — |
| SECONDARY Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 240 |
115; 25 | — |
| SECONDARY Change From Baseline in Plasma HIV RNA at Week 240 |
-2.29; -2.07 | — |
| SECONDARY Change From Baseline in CD4 (T-helper) Cell Count at Week 240 |
301.7; 275.6 | — |
Eligibility Criteria
Inclusion Criteria
- Patient must be HIV positive who must have received less than 7 days total of any antiretroviral therapy (HIV related therapy)
Extension Studies:
- First extension: Patient completed the 48-week base study
- Second extension: Patient completed the first 144-week extension study
Exclusion Criteria
- Less than 18 years of age
- Individuals who currently do not test positive for HIV
Data sourced from ClinicalTrials.gov (NCT00100048). 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.