Phase 2
Completed N=368
A Study of TMC278 in Human Immunodeficiency Virus Type 1 Infected Patients, Who Are Not Treated With Antiretroviral Medicines
Human Immunodeficiency Virus Type 1
Source: ClinicalTrials.gov NCT00110305 ↗
Enrolled (actual)
368
Serious AEs
17.9%
Results posted
Oct 2013
Primary outcomePrimary: Number of Participants With Virologic Response at Week 48 (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm — 74; 76; 70; 220 Participants — p=0.92
Summary
The purpose of this study is to evaluate the dose-response relationship of antiviral activity after 48 weeks treatment with 3 different dose regimens of TMC278.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Virologic Response at Week 48 (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm |
74; 76; 70; 220; 72 | 0.92 |
| SECONDARY Number of Participants With Virologic Response at Week 96 (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm |
71; 68; 65; 204; 63 | 0.45 |
| SECONDARY Number of Participants With Virologic Response at Week 96 (Viral Load Less Than 50 Copies Per mL) - Snapshot Analysis |
71; 70; 66; 207; 64 | — |
| SECONDARY Number of Participants With Virologic Response at Week 240 (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm |
152; 51 | — |
| SECONDARY Number of Participants With Virologic Response at Week 240 (Viral Load Less Than 50 Copies Per mL) - Snapshot Analysis |
150; 51 | — |
| SECONDARY Number of Participants With Virologic Response at Week 240 (Viral Load Less Than 400 Copies/mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm |
166; 54 | — |
| SECONDARY Change From Baseline in CD4+ Cell Count (Absolute) at Week 96 |
145.9; 172.0; 158.9; 159.0; 159.8 | — |
| SECONDARY Change From Baseline in CD4+ Cell Count (Relative) at Week 96 |
8.6; 9.9; 9.3; 9.3; 9.6 | — |
| SECONDARY Change From Baseline in CD4+ Cell Count (Absolute) at Week 240 |
221.0; 217.9 | — |
| SECONDARY Change From Baseline in CD4+ Cell Count (Relative) at Week 240 |
8.7; 9.7 | — |
| SECONDARY Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure |
17; 4; 7; 0; 6; 0 | — |
| SECONDARY Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours (AUC24h) for TMC278 |
2767; 5906; 10281 | — |
| SECONDARY Trough Plasma Concentration (Ctrough) for TMC278 |
92.7; 196.0; 342.0 | — |
| SECONDARY Number of Participants With Virologic Response (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm, by Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours (AUC24h) Quartiles |
48; 50; 55; 51 | — |
Eligibility Criteria
Inclusion Criteria
- Documented human immunodeficiency virus type 1 (HIV-1) infection
- Never been treated with an antiretroviral (ARV) treatment or therapeutic HIV vaccine, or received less than or equal to 2 weeks treatment prior to screening with an nucleoside reverse transcriptase inhibitors
- HIV-1 plasma viral load above 5000 HIV-1 RNA copies per milliliter, at screening
- Cortisol of at least 550 nano moles per liter (19.9 microgram per deciliter) at screening
- Sensitivity to investigator selected nucleosides, at screening
Exclusion Criteria
- Currently having active Acquired Immunodeficiency Syndrome (AIDS) defining illness
- Known or suspected acute (primary) HIV-1 infection
- Any current or history of adrenal disorder, and an acute hepatitis A, B, or C infection
- Documented genotypic evidence of Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) resistance at screening
- Pregnant or breastfeeding females
- Not agree to protocol-defined effective use of contraception
Data sourced from ClinicalTrials.gov (NCT00110305). 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.