Switch to Unboosted Atazanavir With Tenofovir Study
關鍵詞
抽象
描述
Following a screening visit to establish study eligibility, eligible consenting subjects will be randomized 1:1 to one of the two treatment arms (switch to unboosted ATZ or continue ritonavir-boosted ATZ). Randomized open-label treatment will commence following study procedures at baseline. Participants will be assessed at baseline and at weeks 4, 8, 12, 24, 36, and 48. On-study evaluations will include assessment of adverse clinical events and medication changes; blood tests for HIV viral load, CD4 cell count, standard safety parameters, fasting lipids and glucose, and pregnancy testing (if applicable); and urine tests for urinalysis and albumin to creatinine ratio. In addition, a serum sample will be stored at each visit for possible future testing. A timed plasma sample for measurement of pre-dose trough ATZ levels will be obtained once per subject at 4-8 weeks. Quality of life will be assessed by completion of the MOS-HIV questionnaire at baseline and every 12 weeks. Adherence will be assessed based on prescription refill data.
In case of protocol-defined virologic failure, a plasma sample for ATZ trough level will be collected, and genotypic resistance testing will be performed on plasma samples with viral load >250 copies/mL. Subjects with confirmed virologic failure will be asked to come to the clinic and will have their HIV treatment changed to a more effective regimen, selected based on the results of genotypic testing, as soon as possible.
The anticipated rate of confirmed virologic failure in the control arm is no more than 15% over the 48 weeks of the study. Once at least 20 subjects have been assigned to the experimental (switch) treatment arm, if the observed confirmed virologic failure rate in the experimental arm is greater than twice this rate, i.e. >30%, at any time during the study, the study will be stopped. At this time, subjects in the experimental arm will be reassessed as soon as possible and will resume ritonavir-boosted atazanavir or other effective HIV therapy as appropriate. The failure rate will be reassessed at a minimum after each 20 subjects are enrolled into the experimental (switch) arm.
日期
| 最後驗證: | 09/30/2017 |
| 首次提交: | 05/08/2011 |
| 提交的預估入學人數: | 05/09/2011 |
| 首次發布: | 05/10/2011 |
| 上次提交的更新: | 10/23/2017 |
| 最近更新發布: | 07/29/2018 |
| 首次提交結果的日期: | 10/23/2017 |
| 首次提交質量檢查結果的日期: | 10/23/2017 |
| 首次發布結果的日期: | 07/29/2018 |
| 實際學習開始日期: | 06/30/2011 |
| 預計主要完成日期: | 12/31/2014 |
| 預計完成日期: | 11/30/2015 |
狀況或疾病
干預/治療
Drug: Switch
Drug: Continuation
相
手臂組
| 臂 | 干預/治療 |
|---|---|
| Experimental: Switch switch to unboosted atazanavir 400mg daily with the same nucleoside (NRTI) backbone | Drug: Switch switch to unboosted atazanavir 400 mg daily |
| Active Comparator: Continuation continue on current regimen of atazanavir/ritonavir 300mg/100mg with the same nucleoside (NRTI) backbone | Drug: Continuation Continue current regimen of atazanavir 300 mg/ ritonavir 100 mg daily |
資格標準
| 有資格學習的年齡 | 19 Years 至 19 Years |
| 有資格學習的性別 | All |
| 接受健康志願者 | 是 |
| 標準 | Inclusion Criteria: 1. HIV infected adults at least 19 years of age 2. Willing and able to provide informed consent to study participation 3. Currently receiving a regimen including atazanavir 300mg/ritonavir 100mg daily with either tenofovir/emtricitabine (FTC) or tenofovir/lamivudine (3TC), for at least 3 months 4. Plasma viral load (VL) <40 copies/mL for at least 2 consecutive measurements including the screening value, and < 150 copies/mL continuously for at least 3 months prior to screening 5. Current regimen is first antiretroviral regimen, or if not first regimen, no evidence of resistance to any nucleosides (NRTIs) or protease inhibitors (PIs) on previous resistance tests 6. Any CD4 Exclusion Criteria: 1. Clinically significant intolerance or toxicity with current regimen precluding regimen continuation (e.g. intolerance/toxicity to ritonavir necessitating ritonavir discontinuation) 2. pregnancy or breast-feeding 3. antiretroviral regimen including any nonnucleoside reverse transcriptase inhibitor (nevirapine, efavirenz, or etravirine) 4. antiretroviral regimen including any protease inhibitor other than atazanavir and ritonavir 5. concomitant treatment with proton pump inhibitors, rifampin, St. John's wort, or garlic supplements. (Antacids and H2 receptor antagonists will be allowed provided their dosing is separated from atazanavir administration by at least 2 and 10 hours, respectively). |
結果
主要結果指標
1. Proportions of Subjects Experiencing Virologic Failure by Randomized Treatment Arm [at or before 48 weeks.]
次要成果指標
1. Proportions of Subjects in Each Randomized Treatment Arm With Atazanavir Trough Levels Below 150ng/mL [1 month (4-8 weeks)]
2. Proportion of Subjects Experiencing Virologic Failure by Results of 1-month TDM [at or before 48 weeks]
3. Proportions of Subjects Experiencing Virologic Failure by Randomized Treatment Arm [at or before 24 weeks.]
4. Proportion of Subjects Experiencing Virologic Failure by Results of 1-month TDM [at or before 24 weeks]
5. CD4 Cell Count Changes (Absolute and Fraction) [24 and 48 weeks]
6. Safety (Clinical and Laboratory Adverse Events) [24 and 48 weeks]
7. Total Serum Bilirubin Levels [24 and 48 weeks]
8. Metabolic Parameters [24 and 48 weeks]
9. Quality of Life as Assessed by MOS-HIV [24 and 48 weeks]
