Phase 2
Completed N=23
A Study to Evaluate the Pharmacokinetic Profile (How the Body Absorbs, Distributes, Metabolizes and Eliminates a Drug) of TMC125 Plus Tenofovir/Emtricitabine Once Daily With or Without Darunavir/r Once Daily in Antiretroviral (ARV) Naive HIV-1 Patients (Patients Have Never Received ARV Treatment).
Source: ClinicalTrials.gov NCT00534352 ↗Enrolled (actual)
23
Serious AEs
1.2%
Results posted
Apr 2010
Primary outcomePrimary: Number of Participants Contributing to the Pharmacokinetic (PK) Evaluations: Cmin, Cmax, AUC24 & Css,av — 23; 21 participants
Summary
The purpose of this study is to determine the pharmacokinetic profile of TMC125 400mg with tenofovir DF/emtricitabine FDC (fixed dose combination) 300/200mg all dosed once daily with and without darunavir/ritonavir 800/100 mg once daily in HIV-1 infected, antiretroviral (ARV) naÃ-ve patients (patients who have never received ARV treatment).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Contributing to the Pharmacokinetic (PK) Evaluations: Cmin, Cmax, AUC24 & Css,av |
23; 21 | — |
| SECONDARY Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose-Hyperglycemia |
1; 2; 0; 2; 1; 0 | — |
| SECONDARY Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose- Hypoglycemia |
0; 2; 0; 1; 0; 1 | — |
| SECONDARY Number of Participants With Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Glucose- Insulin |
1; 2; 1; 1; 1; 3 | — |
| SECONDARY Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Lipids- Total Cholesteral |
0; 0; 2; 1; 0; 0 | — |
| SECONDARY Number of Participants With Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Lipids- High-density Lipoprotein (HDL) |
4; 8; 6; 2; 0; 0 | — |
| SECONDARY Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Low-density Lipoprotein (LDL) Direct |
0; 0; 1; 1; 0; 0 | — |
| SECONDARY Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Triglycerides |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Virologic Response < 50 HIV-1 RNA Copies/mL (ITT-Observed Case) |
0; 3; 4; 6; 7; 10 | — |
| SECONDARY Log10 Viral Load (HIV-1 RNA Copies/mL): Mean Changes From Baseline(ITT-Observed Case) |
4.19; -1.41; -1.71; -1.77; -1.86; -2.04 | — |
| SECONDARY CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline (ITT-Observed Case) |
403.0; 45.5; 94.0; 59.0; 62.0; 56.0 | — |
| SECONDARY CD4+ Cell Count (Percent): Baseline and Median Changes From Baseline (ITT-Observed Case) |
26.2; 0.1; 4.2; 1.8; 3.0; 4.2 | — |
Eligibility Criteria
Inclusion Criteria
- Documented HIV-1 infection
- Naive to antiretroviral therapy (never received antiretroviral therapy prior to study)
- In the opinion of the investigator, have an indication for antiretroviral therapy
- Able to comply with the protocol requirements
Exclusion Criteria
- No previous or current use of antiretroviral medications (ARVs) for the treatment of HIV infection or hepatitis B/C infection with anti-HIV activity
- No evidence of antiretroviral resistance on current or past resistance assays
- No chronic hepatitis B and/or C co-infection
- No grade 3 or 4 laboratory abnormality as defined by National Institute of Allergy and Infectious Diseases Division of Acquired Immunodeficiency Syndrome (DAIDS) grading tables, or a calculated creatinine clearance (CLCr) < 50 mL/min.
- No known diabetes mellitus or hyperlipidemia requiring lipid-lowering therapy
- No acute viral hepatitis including, but not limited to A, B, or C.
Data sourced from ClinicalTrials.gov (NCT00534352). 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.