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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005143-24 | EudraCT Number |
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The primary objectives of this study are to assess the safety of ABT-450/r/ABT-267 with and without ABT-333 coadministered with and without ribavirin (RBV) for 12 and 24 weeks in HCV GT1- or 4-infected participants with HIV-1 coinfection and to evaluate the percentage of subjects achieving HCV ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks following treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM A | Experimental | ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily |
|
| ARM B | Experimental | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily |
|
| ARM C | Experimental | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily |
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| ARM D | Experimental | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily |
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| ARM E | Experimental | ABT-450/r/ABT-267 and ABT-333 for 12 weeks for noncirrhotic (at screening) GT1b-infected participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-450/r/ABT-267 | Drug | tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in GT1 Analysis Group 1 in Part 2 Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) | SVR12 is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% confidence interval (CI) is calculated using the Wilson score method for binomial distribution. The primary efficacy endpoint was the non-inferiority of the percentage of participants in the GT1 Analysis Group in Part 2 achieving SVR12 compared to the historical SVR12 rate for sofosbuvir plus ribavirin (a non-inferiority threshold of the lower bound of the 95% CI of 74%). | 12 weeks after the last actual dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Part 1a Achieving SVR12 | SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution. | 12 weeks after last dose of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rolando Viani, MD | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25706092 | Background | Sulkowski MS, Eron JJ, Wyles D, Trinh R, Lalezari J, Wang C, Slim J, Bhatti L, Gathe J, Ruane PJ, Elion R, Bredeek F, Brennan R, Blick G, Khatri A, Gibbons K, Hu YB, Fredrick L, Schnell G, Pilot-Matias T, Tripathi R, Da Silva-Tillmann B, McGovern B, Campbell AL, Podsadecki T. Ombitasvir, paritaprevir co-dosed with ritonavir, dasabuvir, and ribavirin for hepatitis C in patients co-infected with HIV-1: a randomized trial. JAMA. 2015 Mar 24-31;313(12):1223-31. doi: 10.1001/jama.2015.1328. | |
| 28412293 |
| Label | URL |
|---|---|
| This clinical study may be evaluating a usage that is not currently FDA-approved. Please see US Prescribing Information for approved uses. | View source |
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In Part 2, participants in Arms E, F, H, I, J all had GT1 infection and received 1 consistent treatment regimen based on label recommendations; they were therefore combined and named the "GT1 Analysis Group."
Part 2 was not designed to test different treatments on the same subject population. Rather, the arms in Part 2 represent subpopulations with different baseline characteristics (hepatitis C virus [HCV] genotype [GT], cirrhotic status, prior HCV therapy experience). Arms F and G were randomized to regimens without and with ribavirin, respectively.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1a: Arm A | ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily |
| FG001 | Part 1a: Arm B |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ARM F | Experimental | ABT-450/r/ABT-267 and ABT-333 for 12 weeks for cirrhotic (at screening) GT1b-infected sofosbuvir-naive participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily |
|
| ARM G | Experimental | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for cirrhotic (at screening) GT1b-infected sofosbuvir-naive participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily |
|
| ARM H | Experimental | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for cirrhotic (at screening) GT1b-infected sofosbuvir-experienced participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily |
|
| ARM I | Experimental | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for noncirrhotic (at screening) GT1a-infected participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily |
|
| ARM J | Experimental | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for cirrhotic (at screening) GT1a-infected participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily |
|
| ARM K | Experimental | ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily |
|
| ARM L | Experimental | ABT-450/r/ABT-267 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily |
|
|
| ABT-333 | Drug | tablet |
|
|
| ribavirin | Drug | tablet |
|
| Percentage of Participants in Part 1b Achieving SVR12 | SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution. | 12 weeks after last dose of study drug |
| Percentage of Participants in Arm F and Arm G of Part 2 Achieving SVR12 | SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution. | 12 weeks after last dose of study drug |
| Percentage of Participants With GT4 HCV in Part 2 Achieving SVR12, by Arm and Overall | SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution. | 12 weeks after last dose of study drug |
| Percentage of Participants in Part 1a With On-Treatment HCV Virologic Failure During the Treatment Period | Percentage of participants with on-treatment HCV virologic failure during the treatment period for each arm in Part 1a. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment. | up to 12 or 24 weeks, based on treatment duration |
| Percentage of Participants in Part 1b With On-Treatment HCV Virologic Failure During the Treatment Period | Percentage of participants with on-treatment HCV virologic failure during the treatment period for each arm and overall in Part 1b. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment. | up to 12 weeks |
| Percentage of Participants in Part 2 With On-Treatment HCV Virologic Failure During the Treatment Period | Percentage of participants with on-treatment HCV virologic failure during the treatment period for arms in Part 2. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment. | up to 12 or 24 weeks, based on treatment duration |
| Percentage of Participants in Part 1a With Relapse12 | Percentage of participants who experienced Relapse12 among participants who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value. Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data. Completion of treatment is defined as study drug duration ≥ 77 days for Arm A and ≥ 154 days for Arm B. The 95% CI is calculated using Wilson score method for the binomial distribution. | up to 12 or 24 weeks, based on treatment duration, after the last actual dose of study drug |
| Percentage of Participants in Part 1b With Relapse12 for Each Arm and Overall | Percentage of participants who experienced Relapse12 among participants who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value. Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data. Completion of treatment is defined as study drug duration ≥ 77 days for Arm C and Arm D. The 95% CI is calculated using Wilson score method for the binomial distribution. | up to 12 weeks after the last actual dose of study drug |
| Percentage of Participants in Part 2 With Relapse12 | Percentage of participants who experienced Relapse12 among those who completed treatment with HCV RNA < LLOQ at final treatment visit and had ≥1 post-treatment HCV RNA value. Relapse12=confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 window) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data, excluding reinfection. Completion of treatment=study drug duration ≥ 77 days for participants who received 12 weeks of treatment and ≥154 days for participants who received 24 weeks of treatment. HCV reinfection=confirmed HCV RNA ≥ LLOQ after the end of treatment in a subject who had HCV RNA < LLOQ at final treatment visit, along with the post-treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis. The 95% CI is calculated using Wilson score method for the binomial distribution. | up to 12 or 24 weeks, based on treatment duration, after the last actual dose of study drug |
| Percentage of Participants in Part 1a With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment | HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL). | End of treatment: HIV Week 12 window for 12-weeks of treatment (Treatment Day 71 - 98) or HIV Week 24 window (Treatment Day 155 - 182) for 24-weeks of treatment. Post-Treatment Week 12 (PTW12): HIV PTW12 window (Post-Treatment Day 57 - 126) |
| Percentage of Participants in Part 1b With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment | HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL). | End of treatment: HIV Week 12 window (Treatment Day 78 - 98). PTW12: HIV PTW12 window (Post-Treatment Day 57 - 126) |
| Percentage of Participants in Part 2 With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment | HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL). | End of treatment: HIV Week 12 window for 12-weeks of treatment (Treatment Day 71 - 98) or HIV Week 24 window (Treatment Day 155 - 182) for 24-weeks of treatment. PTW12: HIV PTW12 window (Post-Treatment Day 57 - 126) |
| Derived |
| Kwo PY, Poordad F, Asatryan A, Wang S, Wyles DL, Hassanein T, Felizarta F, Sulkowski MS, Gane E, Maliakkal B, Overcash JS, Gordon SC, Muir AJ, Aguilar H, Agarwal K, Dore GJ, Lin CW, Liu R, Lovell SS, Ng TI, Kort J, Mensa FJ. Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1-6 without cirrhosis. J Hepatol. 2017 Aug;67(2):263-271. doi: 10.1016/j.jhep.2017.03.039. Epub 2017 Apr 13. |
| 27919899 | Derived | King JR, Khatri A, Trinh R, Viani RM, Ding B, Zha J, Menon R. Pharmacokinetic Evaluation of Darunavir Administered Once or Twice Daily in Combination with Ritonavir or the Three-Direct-Acting Antiviral Regimen of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults Coinfected with Hepatitis C and Human Immunodeficiency Viruses. Antimicrob Agents Chemother. 2017 Jan 24;61(2):e02135-16. doi: 10.1128/AAC.02135-16. Print 2017 Feb. |
| 26743093 | Derived | Saeed S, Strumpf EC, Walmsley SL, Rollet-Kurhajec K, Pick N, Martel-Laferriere V, Hull M, Gill MJ, Cox J, Cooper C, Klein MB; Canadian Co-Infection Cohort Study; Cohen J, Conway B, Cooper C, Cote P, Cox J, Gill J, Haider S, Harris M, Haase D, Hull M, Montaner J, Moodie E, Pick N, Rachlis A, Rouleau D, Sandre R, Tyndall JM, Vachon ML, Walmsley S, Wong D. How Generalizable Are the Results From Trials of Direct Antiviral Agents to People Coinfected With HIV/HCV in the Real World? Clin Infect Dis. 2016 Apr 1;62(7):919-926. doi: 10.1093/cid/civ1222. Epub 2016 Jan 6. |
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
| FG002 | Part 1b: Arm C | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily |
| FG003 | Part 1b: Arm D | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily |
| FG004 | Part 2: GT1 Analysis Group | Participants with HCV genotype (GT)1a or GT1b at screening in Arms E, F, H, I, J (no participants enrolled in Arm H) Arm E: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm F: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm I: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm J: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily |
| FG005 | Part 2: Arm G | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily |
| FG006 | GT4 Analysis Group | Participants with HCV GT4 at screening in Arms K and L (no participants enrolled in Arm L). Arm K: ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1a: Arm A | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily |
| BG001 | Part 1a: Arm B | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily |
| BG002 | Part 1b: Arm C | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily |
| BG003 | Part 1b: Arm D | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily |
| BG004 | Part 2: GT1 Analysis Group | Participants with HCV GT1a or GT1b at screening in Arms E, F, H, I, J (no participants enrolled in Arm H) Arm E: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm F: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm I: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm J: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily |
| BG005 | Part 2: Arm G | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily |
| BG006 | Part 2: GT4 Analysis Group | Arm K: ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily Arm L: no participants enrolled |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Percentage of Participants in GT1 Analysis Group 1 in Part 2 Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) | SVR12 is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% confidence interval (CI) is calculated using the Wilson score method for binomial distribution. The primary efficacy endpoint was the non-inferiority of the percentage of participants in the GT1 Analysis Group in Part 2 achieving SVR12 compared to the historical SVR12 rate for sofosbuvir plus ribavirin (a non-inferiority threshold of the lower bound of the 95% CI of 74%). | Intent-to-treat population: Part 2 randomized or enrolled participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures. The primary efficacy endpoint analysis was based on subjects in the GT 1 Analysis Group in Part 2 containing Arms E, F, H, I, and J. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last actual dose of study drug |
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| Secondary | Percentage of Participants in Part 1a Achieving SVR12 | SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution. | Intent-to-treat population: Part 1a randomized participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after last dose of study drug |
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| Secondary | Percentage of Participants in Part 1b Achieving SVR12 | SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution. | Intent-to-treat population: Part 1b randomized participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after last dose of study drug |
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| Secondary | Percentage of Participants in Arm F and Arm G of Part 2 Achieving SVR12 | SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution. | Intent-to-treat population: Part 2 randomized or enrolled participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after last dose of study drug |
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| Secondary | Percentage of Participants With GT4 HCV in Part 2 Achieving SVR12, by Arm and Overall | SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution. | Intent-to-treat population: Part 2 randomized or enrolled participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after last dose of study drug |
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| Secondary | Percentage of Participants in Part 1a With On-Treatment HCV Virologic Failure During the Treatment Period | Percentage of participants with on-treatment HCV virologic failure during the treatment period for each arm in Part 1a. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment. | Intent-to-treat population: Part 1a randomized participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 12 or 24 weeks, based on treatment duration |
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| Secondary | Percentage of Participants in Part 1b With On-Treatment HCV Virologic Failure During the Treatment Period | Percentage of participants with on-treatment HCV virologic failure during the treatment period for each arm and overall in Part 1b. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment. | Intent-to-treat population: Part 1b randomized participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 12 weeks |
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| Secondary | Percentage of Participants in Part 2 With On-Treatment HCV Virologic Failure During the Treatment Period | Percentage of participants with on-treatment HCV virologic failure during the treatment period for arms in Part 2. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment. | Intent-to-treat population: Part 2 randomized or enrolled participants in the GT1 analysis group (and its composing arms) and GT4 analysis group who received at least 1 dose of study drug. Due to a label change after study start that no longer recommended the Arm G treatment regimen to GT1b cirrhotic subjects, Arm G data was not analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 12 or 24 weeks, based on treatment duration |
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| Secondary | Percentage of Participants in Part 1a With Relapse12 | Percentage of participants who experienced Relapse12 among participants who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value. Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data. Completion of treatment is defined as study drug duration ≥ 77 days for Arm A and ≥ 154 days for Arm B. The 95% CI is calculated using Wilson score method for the binomial distribution. | Intent-to-treat population: Part 1a randomized participants who received at least 1 dose of study drug and who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 12 or 24 weeks, based on treatment duration, after the last actual dose of study drug |
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| Secondary | Percentage of Participants in Part 1b With Relapse12 for Each Arm and Overall | Percentage of participants who experienced Relapse12 among participants who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value. Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data. Completion of treatment is defined as study drug duration ≥ 77 days for Arm C and Arm D. The 95% CI is calculated using Wilson score method for the binomial distribution. | Intent-to-treat population: all Part 1b randomized participants who received at least 1 dose of study drug and who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 12 weeks after the last actual dose of study drug |
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| Secondary | Percentage of Participants in Part 2 With Relapse12 | Percentage of participants who experienced Relapse12 among those who completed treatment with HCV RNA < LLOQ at final treatment visit and had ≥1 post-treatment HCV RNA value. Relapse12=confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 window) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data, excluding reinfection. Completion of treatment=study drug duration ≥ 77 days for participants who received 12 weeks of treatment and ≥154 days for participants who received 24 weeks of treatment. HCV reinfection=confirmed HCV RNA ≥ LLOQ after the end of treatment in a subject who had HCV RNA < LLOQ at final treatment visit, along with the post-treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis. The 95% CI is calculated using Wilson score method for the binomial distribution. | Intent-to-treat population: Part 2 randomized or enrolled participants in the GT1 analysis group (and its composing arms) and GT4 analysis group who received ≥1 dose of study drug, who completed treatment with HCV RNA < LLOQ at final treatment visit, and had ≥1 post-treatment HCV RNA value. Arm G data was not analyzed (see Outcome Measure 8). | Posted | Number | 95% Confidence Interval | percentage of participants | up to 12 or 24 weeks, based on treatment duration, after the last actual dose of study drug |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants in Part 1a With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment | HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL). | Intent-to-treat population: Part 1a randomized participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | End of treatment: HIV Week 12 window for 12-weeks of treatment (Treatment Day 71 - 98) or HIV Week 24 window (Treatment Day 155 - 182) for 24-weeks of treatment. Post-Treatment Week 12 (PTW12): HIV PTW12 window (Post-Treatment Day 57 - 126) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants in Part 1b With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment | HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL). | Intent-to-treat population: Part 1b randomized participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | End of treatment: HIV Week 12 window (Treatment Day 78 - 98). PTW12: HIV PTW12 window (Post-Treatment Day 57 - 126) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants in Part 2 With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment | HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL). | Intent-to-treat population: Part 2 randomized or enrolled participants in the GT1 analysis group (and its composing arms) and GT4 analysis group who received at least 1 dose of study drug. Due to a label change after study start that no longer recommended the Arm G treatment regimen to GT1b cirrhotic subjects, Arm G data was not analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | End of treatment: HIV Week 12 window for 12-weeks of treatment (Treatment Day 71 - 98) or HIV Week 24 window (Treatment Day 155 - 182) for 24-weeks of treatment. PTW12: HIV PTW12 window (Post-Treatment Day 57 - 126) |
|
Protocol-related treatment-emergent adverse events were collected from the first dose of study drug through end of treatment Week 12 and Week 24; treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
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 | Part 1a: Arm A | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily | 0 | 31 | 28 | 31 | ||
| EG001 | Part 1a: Arm B | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily | 0 | 32 | 27 | 32 | ||
| EG002 | Part 1b: Arm C | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily | 0 | 10 | 10 | 10 | ||
| EG003 | Part 1b: Arm D | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily | 1 | 12 | 10 | 12 | ||
| EG004 | Part 2: Arm E | ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily | 1 | 42 | 23 | 42 | ||
| EG005 | Part 2: Arm F | ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily | 0 | 4 | 3 | 4 | ||
| EG006 | Part 2: Arm G | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily | 0 | 5 | 4 | 5 | ||
| EG007 | Part 2: Arm I | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily | 6 | 135 | 109 | 135 | ||
| EG008 | Part 2: Arm J | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily | 2 | 19 | 18 | 19 | ||
| EG009 | Part 2: Arm K | ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily | 1 | 28 | 23 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| PERICARDITIS | Cardiac disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| RECTAL PERFORATION | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA version 19.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| DRUG DEPENDENCE | Psychiatric disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| URETEROLITHIASIS | Renal and urinary disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA version 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| VENTRICULAR EXTRASYSTOLES | Cardiac disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| BLEPHAROSPASM | Eye disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| DRY EYE | Eye disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| EYE DISCHARGE | Eye disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| EYE PRURITUS | Eye disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| EYELID HAEMATOMA | Eye disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| EYELID PTOSIS | Eye disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| OCULAR DISCOMFORT | Eye disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| OCULAR HYPERAEMIA | Eye disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| OCULAR ICTERUS | Eye disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| APHTHOUS ULCER | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| BARRETT'S OESOPHAGUS | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| DIVERTICULUM | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| FAECES SOFT | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| ORAL PAIN | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| EARLY SATIETY | General disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| PERIPHERAL SWELLING | General disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| TEMPERATURE INTOLERANCE | General disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| TENDERNESS | General disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| VESSEL PUNCTURE SITE BRUISE | General disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| JAUNDICE | Hepatobiliary disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| SEASONAL ALLERGY | Immune system disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| ACUTE SINUSITIS | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| HERPES ZOSTER OTICUS | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| ORAL HERPES | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| PYURIA | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| SECONDARY SYPHILIS | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| ARTHROPOD BITE | Injury, poisoning and procedural complications | MedDRA version 19.0 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA version 19.0 | Systematic Assessment |
| |
| EXCORIATION | Injury, poisoning and procedural complications | MedDRA version 19.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA version 19.0 | Systematic Assessment |
| |
| MUSCLE STRAIN | Injury, poisoning and procedural complications | MedDRA version 19.0 | Systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA version 19.0 | Systematic Assessment |
| |
| CREATININE RENAL CLEARANCE DECREASED | Investigations | MedDRA version 19.0 | Systematic Assessment |
| |
| HAEMOGLOBIN DECREASED | Investigations | MedDRA version 19.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA version 19.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| GOUT | Metabolism and nutrition disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| JOINT STIFFNESS | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| JOINT SWELLING | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| MUSCLE TIGHTNESS | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| PERIARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| TENDONITIS | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| SKIN PAPILLOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.0 | Systematic Assessment |
| |
| DISTURBANCE IN ATTENTION | Nervous system disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| MEMORY IMPAIRMENT | Nervous system disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| NEURALGIA | Nervous system disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| SINUS HEADACHE | Nervous system disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| AFFECT LABILITY | Psychiatric disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| AGITATION | Psychiatric disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| DEPRESSED MOOD | Psychiatric disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| IRRITABILITY | Psychiatric disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| LIBIDO INCREASED | Psychiatric disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| STRESS | Psychiatric disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| WITHDRAWAL SYNDROME | Psychiatric disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| BRONCHOSPASM | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| RESPIRATORY TRACT CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| PRURITUS GENERALISED | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| RASH MACULAR | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| RASH PRURITIC | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| SKIN EXFOLIATION | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| SKIN FISSURES | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| THROMBOPHLEBITIS SUPERFICIAL | Vascular disorders | MedDRA version 19.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000163 | Acquired Immunodeficiency Syndrome |
| D019698 | Hepatitis C, Chronic |
| 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 |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C586094 | ombitasvir |
| C585405 | paritaprevir |
| C588260 | dasabuvir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| ≥ 55 years |
|
| Male |
|
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Part 2: Arm E |
ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily |
| OG002 | Part 2: Arm F | ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily |
| OG003 | Part 2: Arm I | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily |
| OG004 | Part 2: Arm J | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily |
| OG005 | Part 2: GT4 Analysis Group | ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily Arm L: no participants enrolled |
| OG006 | Group 2: Arm K | ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily |
|
|
|
|
| OG002 |
| Part 1b: Total |
Arm C: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily Arm D: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily |
|
|
| OG001 | Part 2: Arm E | ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily |
| OG002 | Part 2: Arm F | ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily |
| OG003 | Part 2: Arm I | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily |
| OG004 | Part 2: Arm J | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily |
| OG005 | Part 2: GT4 Analysis Group | Arm K: ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily Arm L: no participants enrolled |
| OG006 | Group 2: Arm K | ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG001 |
| Part 2: Arm E |
ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily |
| OG002 | Part 2: Arm F | ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily |
| OG003 | Part 2: Arm I | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily |
| OG004 | Part 2: Arm J | ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily |
| OG005 | Part 2: GT4 Analysis Group | Arm K: ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily Arm L: no participants enrolled |
| OG006 | Group 2: Arm K | ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily |
|
|