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| Name | Class |
|---|---|
| Tibotec Pharmaceutical Limited | INDUSTRY |
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The purpose of this study is to determine whether the combination of telaprevir, peginterferon alfa-2a, and ribavirin is safe and effective in treating hepatitis C virus (HCV) infection in subjects who are infected with both HCV and human immunodeficiency virus (HIV).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | The dose of ribavirin used (fixed versus weight-based) is region dependent |
|
| Part B | Experimental | The dose of ribavirin used (fixed versus weight-based) is region dependent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telaprevir or matching placebo | Drug | Tablet, Oral, 750 mg, q8h, 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Achieving Undetectable HCV RNA at Week 12 | 12 weeks after first dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Achieving Undetectable HCV RNA at Week 4 and Week 12 | number of subjects with undetectable HCV RNA | 4 and 12 weeks after the first dose of study drug |
| Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks (SVR12) and 24 Weeks (SVR24) After Last Planned Dose of Study Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Vertex Pharmaceuticals Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beverly Hills | California | 90211 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23685940 | Derived | Sulkowski MS, Sherman KE, Dieterich DT, Bsharat M, Mahnke L, Rockstroh JK, Gharakhanian S, McCallister S, Henshaw J, Girard PM, Adiwijaya B, Garg V, Rubin RA, Adda N, Soriano V. Combination therapy with telaprevir for chronic hepatitis C virus genotype 1 infection in patients with HIV: a randomized trial. Ann Intern Med. 2013 Jul 16;159(2):86-96. doi: 10.7326/0003-4819-159-2-201307160-00654. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: T/PR | Drug: telaprevir tablet, oral, 750 mg, q8h, 12 weeks Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks The dose of ribavirin used (fixed versus weight-based) was region dependent. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| telaprevir or matching placebo |
| Drug |
Tablet, Oral, 750 mg or 1125 mg, q8h, 12 weeks |
|
| peginterferon alfa-2a | Biological | Subcutaneous injection, 180 μg, once weekly, 48 weeks |
|
| ribavirin (fixed dose) | Drug | Tablet, Oral, 800 mg, b.i.d., 48 weeks |
|
| ribavirin (weight-based dose) | Drug | Tablet, Oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks |
|
| 12 weeks after last dose of study drug |
| Effect of Efavirenz-based (EFV) and Atazanavir-based (ATV/r) Highly Active Antiretroviral Therapy(HAART) on Telaprevir Exposure | through 12 weeks after first dose of study drug |
| Median Trough Plasma Concentration (Ctrough) Ratios of Efavirenz and Tenofovir (Part B Only, Subjects on EFV-based HAART) | Ctrough ratio of HAART medication with telaprevir (test) and without telaprevir (reference) | through 12 weeks after first dose of study drug |
| Median Trough Plasma Concentration (Ctrough) Ratios of Atazanavir (ATZ), Ritonavir, and Tenofovir (Part B Only, Subjects on ATV-based HAART) | Ctrough of HAART medication with telaprevir (test) and without telaprevir (reference) | through 12 weeks after first dose of study drug |
| San Diego |
| California |
| 92093 |
| United States |
| San Francisco | California | 94110 | United States |
| Miami | Florida | 33125 | United States |
| Orlando | Florida | 32803 | United States |
| Chicago | Illinois | 60612 | United States |
| Baltimore | Maryland | 21287 | United States |
| Boston | Massachusetts | 02114 | United States |
| New York | New York | 10029 | United States |
| Cincinnati | Ohio | 45267 | United States |
| Dallas | Texas | 75204 | United States |
| Paris | France |
| Bonn-Venusberg | Germany |
| Hamburg | Germany |
| Barcelona | Spain |
| Madrid | Spain |
| FG001 | Part A: Pbo/PR | Drug: placebo tablet, oral, 750 mg, q8h, 12 weeks Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks The dose of ribavirin used (fixed versus weight-based) was region dependent. |
| FG002 | Part B: EFV-based HAART + T/PR | Drug: efavirenz, tenofovir disoproxil fumarate, and emtricitabine Drug: telaprevir tablet, oral, 750 mg, q8h, 12 weeks Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks The dose of ribavirin used (fixed versus weight-based) was region dependent. |
| FG003 | Part B: EFV-based HAART + Pbo/PR | Drug: efavirenz, tenofovir disoproxil fumarate, and emtricitabine Drug: placebo tablet, oral, 750 mg, q8h, 12 weeks Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks The dose of ribavirin used (fixed versus weight-based) was region dependent. |
| FG004 | Part B: ATV/R-based HAART + T/PR | Drug: ritonavir-boosted atazanavir, tenofovir disoproxil fumarate, and emtricitabine or lamivudine Drug: telaprevir tablet, oral, 750 mg, q8h, 12 weeks Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks The dose of ribavirin used (fixed versus weight-based) was region dependent. |
| FG005 | Part B: ATV/R-based HAART + Pbo/PR | Drug: ritonavir-boosted atazanavir, tenofovir disoproxil fumarate, and emtricitabine or lamivudine Drug: placebo tablet, oral, 750 mg, q8h, 12 weeks Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks The dose of ribavirin used (fixed versus weight-based) was region dependent. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized subjects who received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A: T/PR | Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART. |
| BG001 | Part A: Pbo/PR | Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART. |
| BG002 | Part B: EFV-based HAART + T/PR | Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz(EFV)-based highly active antiretroviral therapy(HAART) for the entire 48 week study. |
| BG003 | Part B: EFV-based HAART + Pbo/PR | Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz(EFV)-based highly active antiretroviral therapy(HAART) for the entire 48 week study. |
| BG004 | Part B: ATV/R-based HAART + T/PR | Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir(ATV/r)-based highly active antiretroviral therapy(HAART) for the entire 48 week study. |
| BG005 | Part B: ATV/R-based HAART + Pbo/PR | Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir(ATV/r)-based highly active antiretroviral therapy(HAART) for the entire 48 week study. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Proportion of Subjects Achieving Undetectable HCV RNA at Week 12 | Subjects who were randomized and received at least 1 dose of study drug | Posted | Number | participants | 12 weeks after first dose of study drug |
|
|
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects Achieving Undetectable HCV RNA at Week 4 and Week 12 | number of subjects with undetectable HCV RNA | Subjects who were randomized and received at least 1 dose of study drug | Posted | Number | participants | 4 and 12 weeks after the first dose of study drug |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks (SVR12) and 24 Weeks (SVR24) After Last Planned Dose of Study Treatment | subjects who received at least 1 dose of study drug. | Posted | Number | participants | 12 weeks after last dose of study drug |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Effect of Efavirenz-based (EFV) and Atazanavir-based (ATV/r) Highly Active Antiretroviral Therapy(HAART) on Telaprevir Exposure | subjects with available plasma concentration data | Posted | Least Squares Mean | 90% Confidence Interval | ratio (test/reference) | through 12 weeks after first dose of study drug |
|
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Trough Plasma Concentration (Ctrough) Ratios of Efavirenz and Tenofovir (Part B Only, Subjects on EFV-based HAART) | Ctrough ratio of HAART medication with telaprevir (test) and without telaprevir (reference) | subjects with available concentration data | Posted | Median | Full Range | ratio (test/reference) | through 12 weeks after first dose of study drug |
|
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Trough Plasma Concentration (Ctrough) Ratios of Atazanavir (ATZ), Ritonavir, and Tenofovir (Part B Only, Subjects on ATV-based HAART) | Ctrough of HAART medication with telaprevir (test) and without telaprevir (reference) | subjects with available concentration data | Posted | Median | Full Range | ratio (test/reference) | through 12 weeks after first dose of study drug |
|
|
first dose of study drug until 4 weeks after the last dose of study drug
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | T/PR | Pooled T/PR from Part A and Part B | 7 | 38 | 38 | 38 | ||
| EG001 | Total PR | Pooled PR from Part A and Part B | 2 | 22 | 22 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Groin Infection | Infections and infestations | MedDRA (11.0) |
| ||
| Appendicitis | Infections and infestations | MedDRA (11.0) |
| ||
| Pyelonephritis Acute | Infections and infestations | MedDRA (11.0) |
| ||
| Cellulitis Staphylococcal | Infections and infestations | MedDRA (11.0) |
| ||
| Staphylococcal Abscess | Infections and infestations | MedDRA (11.0) |
| ||
| Staphylococcal Infection | Infections and infestations | MedDRA (11.0) |
| ||
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.0) |
| ||
| Hemolytic Anemia | Blood and lymphatic system disorders | MedDRA (11.0) |
| ||
| Acute Myocardial Infarction | Cardiac disorders | MedDRA (11.0) |
| ||
| Peritonitis | Gastrointestinal disorders | MedDRA (11.0) |
| ||
| Non-cardiac Chest Pain | General disorders | MedDRA (11.0) |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (11.0) |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (11.0) |
| ||
| Epididymitis | Reproductive system and breast disorders | MedDRA (11.0) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | General disorders | MedDRA (11.0) |
| ||
| Pyrexia | General disorders | MedDRA (11.0) |
| ||
| Influenza-like Illness | General disorders | MedDRA (11.0) |
| ||
| Irritability | General disorders | MedDRA (11.0) |
| ||
| Fatigue | General disorders | MedDRA (11.0) |
| ||
| Injection Site Erythema | General disorders | MedDRA (11.0) |
| ||
| Pain | General disorders | MedDRA (11.0) |
| ||
| Malaise | General disorders | MedDRA (11.0) |
| ||
| Nausea | Gastrointestinal disorders | MedDRA (11.0) |
| ||
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) |
| ||
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (11.0) |
| ||
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (11.0) |
| ||
| Anogenital Dysplasia | Gastrointestinal disorders | MedDRA (11.0) |
| ||
| Cheilitis | Eye disorders | MedDRA (11.0) |
| ||
| Dry Mouth | Gastrointestinal disorders | MedDRA (11.0) |
| ||
| Haemorrhoids | Gastrointestinal disorders | MedDRA (11.0) |
| ||
| Headache | Nervous system disorders | MedDRA (11.0) |
| ||
| Dizziness | Nervous system disorders | MedDRA (11.0) |
| ||
| Paraesthesia | Nervous system disorders | MedDRA (11.0) |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.0) |
| ||
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.0) |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (11.0) |
| ||
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA (11.0) |
| ||
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA (11.0) |
| ||
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (11.0) |
| ||
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (11.0) |
| ||
| Depression | Psychiatric disorders | MedDRA (11.0) |
| ||
| Insomnia | Psychiatric disorders | MedDRA (11.0) |
| ||
| Anxiety | Psychiatric disorders | MedDRA (11.0) |
| ||
| Depressed Mood | Psychiatric disorders | MedDRA (11.0) |
| ||
| Affect Lability | Psychiatric disorders | MedDRA (11.0) |
| ||
| Libido Decreased | Psychiatric disorders | MedDRA (11.0) |
| ||
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) |
| ||
| Fungal Skin Infection | Infections and infestations | MedDRA (11.0) |
| ||
| Sinusitis | Infections and infestations | MedDRA (11.0) |
| ||
| Neutropenia | Blood and lymphatic system disorders | MedDRA (11.0) |
| ||
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.0) |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) |
| ||
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA (11.0) |
| ||
| Weight Decreased | Investigations | MedDRA (11.0) |
| ||
| Blood Bilirubin Increased | Investigations | MedDRA (11.0) |
| ||
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (11.0) |
| ||
| Anorexia | Metabolism and nutrition disorders | MedDRA (11.0) |
| ||
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (11.0) |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (11.0) |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) |
| ||
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) |
| ||
| Pharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) |
| ||
| Cholelithiasis | Hepatobiliary disorders | MedDRA (11.0) |
| ||
| Jaundice | Hepatobiliary disorders | MedDRA (11.0) |
| ||
| Hypothyroidism | Endocrine disorders | MedDRA (11.0) |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | Vertex Pharmaceuticals Incorporated | 1-617-444-6777 | medicalinfo@vrtx.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C486464 | telaprevir |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black/African American |
|
| American Indian/Alaska Native |
|
| Other |
|
| United States |
|
| Europe |
|
| Germany |
|
| Spain |
|
| France |
|
Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
| OG004 | Part B: ATV/R-based HAART + T/PR | Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study. |
| OG005 | Part B: ATV/R-based HAART + Pbo/PR | Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study. |
|
|
| OG004 | Part B: ATV/R-based HAART + T/PR | Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study. |
| OG005 | Part B: ATV/R-based HAART + Pbo/PR | Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study. |
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