Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| TMC125HIV2032 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA | INDUSTRY |
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).
This is a multi-center, open-label (doctors and patients know which drug is being given), Phase IIa clinical trial to evaluate the pharmacokinetic (PK) profile, safety and tolerability of TMC125 dosed once daily with tenofovir/emtricitabine with and without darunavir/ritonavir in antiretroviral naive HIV-1 infected patients. There will be an optional open-label extension phase to evaluate effectiveness, safety and tolerability of continued tenofovir/emtricitabine with darunavir/ritonavir all dosed once daily for 48 weeks. This study will be conducted in the United States at up to 5 sites where 20 patients will initially receive TMC125 400mg with tenofovir DF/emtricitabine FDC 300/200 mg all dosed once daily for 14 days. On Day 15, a blood sample will be obtained and intensive TMC125 pharmacokinetic (PK) values and fasting lipids (check of total cholesterol, direct LDL, HDL, triglycerides) following a 10 hour fast (no eating) will be assessed. Patients will then add darunavir / ritonavir 800/100 mg once a day to the regimen for Days 15 - 29. On Day 29 intensive PK sampling for TMC125, darunavir and ritonavir will be performed and fasting lipids will be evaluated. On Day 29, patients will discontinue TMC125 and continue darunavir/ritonavir 800/100 mg and tenofovir DF/emtricitabine FDC 300/200 mg all dosed once daily. On Day 43, fasting lipids will be assessed. At this point, patients may enter the optional open-label extension phase of the study and continue treatment with darunavir/ritonavir 800mg/100 mg and tenofovir DF/emtricitabine FDC 300/200mg all dosed once daily through 48 total weeks of treatment. The study will consist of a total of 8 visits including 2 intensive PK visits. Within 4 weeks after the Screening Visit, the study site should have received all data to determine a patient's eligibility for the study. The Baseline Visit (Day 1) will be followed by a study visit on Day 8. An intensive PK visit will occur on Day 15. After modification of therapy on Day 15, a study visit will occur on Day 22. A second intensive PK visit will occur on Day 29. On Day 43 a study visit will occur at which point study therapy will be discontinued unless the patient elects to continue in the optional open label extension phase of the study. Patients electing to continue in the open-label extension will have 4 additional study visits at Week 12, 24, 36 and 48. All patients will be asked to return for a 4-week follow-up visit after the completion of study treatment.
During the treatment period, the patient will be seen at regular visits during which the investigator will assess the patient's medical condition, any Adverse Events and study drug compliance. Laboratory evaluations for effectiveness and safety will be done at regular visits as well as blood pressure monitoring. All patients will receive TMC125 400 mg orally (by mouth) once daily. Tenofovir DF 300mg/emtricitabine 200mg will be dosed once daily orally as the fixed dose combination. Darunavir/ritonavir will be dosed 800/100 mg orally once daily. All doses should be administered following a meal.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | TMC125; darunavir; ritonavirTMC125 400mg once daily for 4 weeks; Darunavir-800mg once daily for 48 weeks; Ritonavir-100mg once daily for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMC125; darunavir; ritonavir | Drug | TMC125 400mg once daily for 4 weeks; Darunavir-800mg once daily for 48 weeks; Ritonavir-100mg once daily for 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Contributing to the Pharmacokinetic (PK) Evaluations: Cmin, Cmax, AUC24 & Css,av | At visit Days 14 & 28, samples were collected pre-dose and at 1, 2, 3, 4, 6, 9, and 12 hours post-dose. An additional sample was taken at 24 hours (Day 15 or 29 as applicable) post-dose. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose-Hyperglycemia | Number of Participants with Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose-Hyperglycemia. Worst Grade is based on the National Institute of Allergy and Infectious Diseases Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity grading scale, 0,1,2,3,4 and 5 : None, Mild, Moderate, Severe, Life-threatening and Death. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tibotec, Inc. Clinical Trial | Tibotec, Inc | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20710052 | Derived | DeJesus E, Lalezari JP, Osiyemi OO, Ruane PJ, Ryan R, Kakuda TN, Witek J. Pharmacokinetics of once-daily etravirine without and with once-daily darunavir/ritonavir in antiretroviral-naive HIV type-1-infected adults. Antivir Ther. 2010;15(5):711-20. doi: 10.3851/IMP1562. |
Not provided
Not provided
Not provided
The 42-day open-label main treatment phase of this trial was conducted from 10 December 2007 to 27 May 2008. Four investigators from the US participated in this multicenter trial. A total of 35 subjects were screened and of these, 23 subjects entered the trial and started the first treatment phase
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | TDF/FTC +/- TMC125 +/- DRV/Rtv | In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed. In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed. In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed. Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment A: TMC125 + TDF/FTC |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Day 1 through 42 and Week 48 |
| Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose- Hypoglycemia | Number of participants with Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose- Hypoglycemia. Worst Grade is based on the DAIDS toxicity grading scale 0-5: No Toxicity-Death. | Day 1 through 42 and Week 48 |
| Number of Participants With Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Glucose- Insulin | Number of participants with Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Glucose- Insulin. Normal Range: 3.0 - 27.0 ulU/mL | Day 1 through 42 and Week 48 |
| Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Lipids- Total Cholesteral | Number of participants with Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Lipids- Total Cholesteral. Worst Grade is based on the DAIDS toxicity grading scale, 0-5 : No Toxicity-Death. | Day 1 through 42 and Week 48 |
| Number of Participants With Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Lipids- High-density Lipoprotein (HDL) | Number of participants with Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Lipids- High-density lipoprotein (HDL). Normal Range: 40 - 59 mG/dL 1.03 - 1.53 mmol/L | Day 1 through 42 and Week 48 |
| Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Low-density Lipoprotein (LDL) Direct | Number of participants with Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Low-density lipoprotein (LDL) Direct. Worst Grade is based on the DAIDS toxicity grading scale, 0-5 : No Toxicity-Death. | Day 1 through 42 and Week 48 |
| Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Triglycerides | Number of participants with Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Triglycerides. Worst Grade is based on the DAIDS toxicity grading scale, 0-5 : No Toxicity-Death. | Day 1 through 48 and Week 48 |
| Virologic Response < 50 HIV-1 RNA Copies/mL (ITT-Observed Case) | Virologic Response < 50 HIV-1 RNA Copies/mL (ITT-Observed Case). | Day 8, 14, 22, 28, 42 and Week 48 |
| Log10 Viral Load (HIV-1 RNA Copies/mL): Mean Changes From Baseline(ITT-Observed Case) | Log10 Viral Load (HIV-1 RNA copies/mL): Mean Changes From Baseline(ITT-Observed Case). | Baseline, Day 8, 14, 22, 28 & 42 and Week 48 |
| CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline (ITT-Observed Case) | CD4+ Cell Count (x 10^6 cell/L): Baseline and Median Changes From Baseline (ITT-Observed Case). | Baseline, Day 8, 14, 22, 28 & 42 ans Week 48 |
| CD4+ Cell Count (Percent): Baseline and Median Changes From Baseline (ITT-Observed Case) | Baseline, Day 8, 14, 22, 28 & 42 and Week 48 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Treatment B: TMC125 + TDF/FTC + DRV/Rtv |
|
| Treatment C: DRV/Rtv + TDF/FTC |
|
|
| Optional Extension: DRV/Rtv + TDF/FTC |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TDF/FTC +/- TMC125 +/- DRV/Rtv | In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed. In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed. In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed. Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| CYP2C19 Genotyping | There are 21 participants with genotyping data. | Number | participants |
| ||||||||||||||||||||||
| CYP2C9 Genotyping | There are 21 participants with genotyping data. | Number | participants |
| ||||||||||||||||||||||
| Family History Related to Skin Disease | Number | participants |
| |||||||||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
| ||||||||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| ||||||||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Contributing to the Pharmacokinetic (PK) Evaluations: Cmin, Cmax, AUC24 & Css,av | At visit Days 14 & 28, samples were collected pre-dose and at 1, 2, 3, 4, 6, 9, and 12 hours post-dose. An additional sample was taken at 24 hours (Day 15 or 29 as applicable) post-dose. | Intention To Treat (ITT) population | Posted | Number | participants | 6 weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose-Hyperglycemia | Number of Participants with Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose-Hyperglycemia. Worst Grade is based on the National Institute of Allergy and Infectious Diseases Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity grading scale, 0,1,2,3,4 and 5 : None, Mild, Moderate, Severe, Life-threatening and Death. | ITT | Posted | Number | participants | Day 1 through 42 and Week 48 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose- Hypoglycemia | Number of participants with Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose- Hypoglycemia. Worst Grade is based on the DAIDS toxicity grading scale 0-5: No Toxicity-Death. | ITT | Posted | Number | participants | Day 1 through 42 and Week 48 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Glucose- Insulin | Number of participants with Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Glucose- Insulin. Normal Range: 3.0 - 27.0 ulU/mL | Posted | Number | participant | Day 1 through 42 and Week 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Lipids- Total Cholesteral | Number of participants with Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Lipids- Total Cholesteral. Worst Grade is based on the DAIDS toxicity grading scale, 0-5 : No Toxicity-Death. | ITT | Posted | Number | participants | Day 1 through 42 and Week 48 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Lipids- High-density Lipoprotein (HDL) | Number of participants with Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Lipids- High-density lipoprotein (HDL). Normal Range: 40 - 59 mG/dL 1.03 - 1.53 mmol/L | ITT | Posted | Number | participants | Day 1 through 42 and Week 48 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Low-density Lipoprotein (LDL) Direct | Number of participants with Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Low-density lipoprotein (LDL) Direct. Worst Grade is based on the DAIDS toxicity grading scale, 0-5 : No Toxicity-Death. | ITT | Posted | Number | participants | Day 1 through 42 and Week 48 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Triglycerides | Number of participants with Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Triglycerides. Worst Grade is based on the DAIDS toxicity grading scale, 0-5 : No Toxicity-Death. | ITT | Posted | Number | participants | Day 1 through 48 and Week 48 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Response < 50 HIV-1 RNA Copies/mL (ITT-Observed Case) | Virologic Response < 50 HIV-1 RNA Copies/mL (ITT-Observed Case). | ITT | Posted | Number | participants | Day 8, 14, 22, 28, 42 and Week 48 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Log10 Viral Load (HIV-1 RNA Copies/mL): Mean Changes From Baseline(ITT-Observed Case) | Log10 Viral Load (HIV-1 RNA copies/mL): Mean Changes From Baseline(ITT-Observed Case). | ITT (Observed) | Posted | Mean | Standard Error | copies/mL | Baseline, Day 8, 14, 22, 28 & 42 and Week 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline (ITT-Observed Case) | CD4+ Cell Count (x 10^6 cell/L): Baseline and Median Changes From Baseline (ITT-Observed Case). | Posted | Median | Full Range | x 10^6 cell/L | Baseline, Day 8, 14, 22, 28 & 42 ans Week 48 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | CD4+ Cell Count (Percent): Baseline and Median Changes From Baseline (ITT-Observed Case) | ITT (Observed) | Posted | Median | Full Range | Percent Change from Baseline | Baseline, Day 8, 14, 22, 28 & 42 and Week 48 |
|
|
Baseline, Day 8, 14, 22, 28, 42 and Week 48
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A | TMC125 + TDF/FTC | 0 | 23 | 10 | 23 | ||
| EG001 | Treatment B | TMC125 + TDF/FTC + DRV/rtv | 0 | 21 | 9 | 21 | ||
| EG002 | Treatment C | DRV/rtv + TDF/FTC | 0 | 21 | 4 | 21 | ||
| EG003 | Optional Extension | DRV/rtv + TDF/FTC | 1 | 18 | 13 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burkitt's Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acne Cystic | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Anogenital Dysplasia | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Areflexia | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Blood Urine Present | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Bronchitis Chronic | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Conjunctival Haemorrhage | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Dermatitus | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Drug Exposure During Pregnancy | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Intracranial Hypotension | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Oral Pain | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Syphilis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
If TTCA does not publish within 12 months after study conclusion or after TTCA confirms there will be no multicenter publication, Institution may publish their results from their site individually, provided TTCA has 60 day review for confidentiality and additional 60 day delay for patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Tibotec Therapeutics Clinical Affairs | Tibotec Therapeutics Clinical Affairs, Division of Centocor Ortho Biotech Services, LLC | 877-732-2488 |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C451734 | etravirine |
| D000069454 | Darunavir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D001393 | Azoles |
Not provided
Not provided
| Hispanic |
|
| CYP2C19*1/CYP2C19*2 : Intermediate Phenotype |
|
| CYP2C19*17/CYP2C19*17 : Ultrarapid Phenotype |
|
| CYP2C19*17/CYP2C19*2 : Normal Phenotype |
|
| CYP2C19*2/CYP2C19*2 : Poor Phenotype |
|
| No data |
|
| No data |
|
| Non-Inferiority or Equivalence |
Equivalence was shown for Cmin as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits. |
| Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means. | Mixed Models Analysis (Cmax) | The linear mixed effects model was controlled for treatment as fixed effects, and subject as a random effect. | No p-values. | Least Square (LS) mean ratio | 102.6 | 90 | 92.91 | 113.3 | The results are for the mean ratio of Cmax. Numerator: Treatment B Denominator: Treatment A | Yes | Non-Inferiority or Equivalence | Equivalence was shown for Cmax as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits. |
| Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means. | Mixed Models Analysis (AUC24) | The linear mixed effects model was controlled for treatment as fixed effects, and subject as a random effect. | No p-values. | LS means of ratios | 98.97 | 90 | 89.23 | 109.8 | The results are for the mean ratio of AUC24. Numerator: Treatment B Denominator: Treatment A | Yes | Non-Inferiority or Equivalence | Equivalence was shown for AUC24 as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits. |
| Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means. | Mixed Models Analysis (Css,av) | The linear mixed effects model was controlled for treatment as fixed effects, and subject as a random effect. | No p-values. | Least Square (LS) mean ratio | 99.30 | 90 | 89.39 | 110.3 | The results are for the mean ratio of Css,av. Numerator: Treatment B Denominator: Treatment A | Yes | Non-Inferiority or Equivalence | Equivalence was shown for Css,av as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits. |
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
|
| Participants |
|
|
| Participants |
|
|
|
|
|
|
|
|
|