SNPMiner Trials by Shray Alag

NCT00511368 (37) NCT00460382 (36) NCT04504071 (35) NCT03783286 (33) NCT04172597 (32) NCT02404233 (29) NCT00959894 (28) NCT00706147 (28) NCT00121017 (28) NCT01685801 (27) NCT04513626 (26) NCT01736761 (26) NCT04495348 (24) NCT02673398 (23) NCT02499978 (22) NCT01605084 (21) NCT04254705 (21) NCT02069834 (21) NCT00939770 (18) NCT01792570 (18) NCT01199939 (18) NCT00356616 (18) NCT02728258 (17) NCT02707601 (17) NCT02770508 (16) NCT00711009 (16) NCT00630864 (16) NCT00491556 (15) NCT04085315 (15) NCT02616029 (15) NCT00830804 (15) NCT01170962 (14) NCT00984152 (14) NCT03953898 (14) NCT00727597 (14) NCT03212274 (14) NCT00337467 (13) NCT00098293 (13) NCT02159599 (13) NCT00424814 (12) NCT04432454 (12) NCT02527096 (12) NCT01849003 (12) NCT03781063 (12) NCT03683524 (11) NCT01614457 (11) NCT00460746 (11) NCT00993148 (11) NCT03061331 (11) NCT02494882 (11) NCT03068312 (11) NCT04453436 (11) NCT01521338 (10) NCT01614470 (10) NCT01423812 (10) NCT00358917 (10) NCT04415268 (10) NCT00511381 (10) NCT03911713 (9) NCT02742519 (9) NCT02725567 (9) NCT03045523 (9) NCT00438152 (9) NCT01102972 (9) NCT02971839 (9) NCT00740064 (9) NCT02605954 (9) NCT00379405 (9) NCT01562847 (9) NCT02616783 (9) NCT04272242 (9) NCT02445053 (9) NCT00242840 (9) NCT02724527 (9) NCT04209465 (9) NCT04585737 (8) NCT02082977 (8) NCT00112775 (8) NCT00383318 (8) NCT03659214 (8) NCT03631732 (8) NCT00118898 (8) NCT01888562 (8) NCT02633189 (8) NCT03565692 (8) NCT03843775 (8) NCT01161576 (8) NCT02167165 (8) NCT00344461 (8) NCT04519398 (7) NCT02154490 (7) NCT03232892 (7) NCT00650832 (7) NCT04549025 (7) NCT00440947 (7) NCT02784639 (7) NCT03572140 (6) NCT01237444 (6) NCT00532168 (6) NCT01102569 (6) NCT04424368 (6) NCT01414985 (6) NCT00525733 (6) NCT02308332 (6) NCT01487265 (6) NCT00049933 (5) NCT02389920 (5) NCT03351699 (5) NCT04197934 (5) NCT02272998 (5) NCT00122590 (5) NCT04204330 (5) NCT02450591 (5) NCT01173029 (5) NCT02675829 (5) NCT02858921 (5) NCT01914484 (5) NCT00187733 (5) NCT02554591 (5) NCT01501604 (5) NCT02716116 (5) NCT01136460 (5) NCT00187655 (5) NCT00350272 (5) NCT00837135 (5) NCT03202862 (5) NCT01707199 (5) NCT03839342 (5) NCT01323010 (4) NCT02248324 (4) NCT01698905 (4) NCT01737359 (4) NCT01306045 (4) NCT02804100 (4) NCT01456676 (4) NCT00588172 (4) NCT03434418 (4) NCT03593993 (4) NCT01804140 (4) NCT02882308 (4) NCT03497767 (4) NCT04106024 (4) NCT02716311 (4) NCT04405674 (4) NCT03599518 (4) NCT01675778 (4) NCT01604122 (4) NCT01297777 (4) NCT04519970 (4) NCT00705679 (4) NCT04147351 (4) NCT04129502 (4) NCT03976856 (4) NCT02335944 (4) NCT03948763 (4) NCT03255083 (4) NCT04002830 (4) NCT02635815 (4) NCT03066206 (4) NCT01331642 (4) NCT00557245 (4) NCT01922583 (4) NCT02893332 (4) NCT03592888 (4) NCT02257424 (4) NCT03874858 (4) NCT00017732 (4) NCT00187720 (4) NCT02593539 (4) NCT01185587 (4) NCT04439292 (4) NCT03884348 (4) NCT01309243 (4) NCT03209063 (4) NCT04160546 (4) NCT03292302 (4) NCT02418234 (4) NCT02535338 (3) NCT02192697 (3) NCT03410043 (3) NCT03845296 (3) NCT02914990 (3) NCT02113813 (3) NCT01532011 (3) NCT04340388 (3) NCT00962533 (3) NCT03856411 (3) NCT04049266 (3) NCT02973763 (3) NCT02926092 (3) NCT00271973 (3) NCT04256941 (3) NCT03812809 (3) NCT02954523 (3) NCT01784068 (3) NCT03446417 (3) NCT02841579 (3) NCT02025114 (3) NCT01288521 (3) NCT01385683 (3) NCT02279004 (3) NCT00998582 (3) NCT03111901 (3) NCT01352715 (3) NCT01619774 (3) NCT01045369 (3) NCT02246998 (3) NCT03969823 (3) NCT00895596 (3) NCT02398929 (3) NCT00724711 (3) NCT04029350 (3) NCT03737994 (3) NCT01443806 (3) NCT02629822 (3) NCT03463525 (3) NCT00710112 (3) NCT03623750 (3) NCT04283955 (3) NCT02743923 (3) NCT01016106 (3) NCT01259089 (3) NCT03971474 (3) NCT02917993 (3) NCT02368990 (3) NCT00279110 (3) NCT02485652 (3) NCT00312169 (3) NCT04541407 (3) NCT02769286 (3) NCT00747487 (3) NCT04267913 (3) NCT01429597 (3) NCT04023617 (3) NCT03790228 (3) NCT01759888 (3) NCT04429152 (3) NCT01810718 (3) NCT02725632 (3) NCT01090011 (3) NCT04544111 (3) NCT02926768 (3) NCT02981108 (3) NCT02459743 (3) NCT00654823 (3) NCT01037127 (3) NCT04439305 (3) NCT01028222 (3) NCT01542411 (3) NCT01031446 (3) NCT02726269 (3) NCT01892644 (3) NCT03260491 (3) NCT01802632 (3) NCT02720094 (3) NCT02630186 (3) NCT01627132 (3) NCT02690675 (3) NCT01013506 (3) NCT04252339 (3) NCT02496663 (3) NCT03386955 (3) NCT03394118 (3) NCT04212702 (3) NCT01754025 (3) NCT01160276 (3) NCT00121979 (3) NCT03228277 (3) NCT04351555 (3) NCT01243346 (3) NCT04510415 (3) NCT02796274 (3) NCT02774005 (3) NCT02064491 (3) NCT04233021 (3) NCT03799601 (3) NCT00260260 (3) NCT02094261 (3) NCT04245085 (3) NCT01282151 (3) NCT03058094 (3) NCT02520778 (3) NCT03161808 (3) NCT04181060 (3) NCT01342679 (3) NCT01443273 (3) NCT01593254 (3) NCT04433481 (3) NCT02529995 (3) NCT03502850 (3) NCT02771314 (3) NCT03823807 (3) NCT03270527 (3) NCT02688881 (3) NCT01005602 (3) NCT02442349 (3) NCT02282267 (2) NCT02684591 (2) NCT03381430 (2) NCT02178397 (2) NCT03608215 (2) NCT02603107 (2) NCT03370770 (2) NCT03322696 (2) NCT00525473 (2) NCT03333343 (2) NCT03127449 (2) NCT01781026 (2) NCT02503722 (2) NCT00975871 (2) NCT03964233 (2) NCT03388099 (2) NCT02317016 (2) NCT03845270 (2) NCT03519958 (2) NCT03918304 (2) NCT02151721 (2) NCT02777658 (2) NCT01016444 (2) NCT02971501 (2) NCT03101254 (2) NCT03178617 (2) NCT01774721 (2) NCT03574753 (2) NCT01357655 (2) NCT01766713 (2) NCT02097225 (2) NCT00658164 (2) NCT03622593 (2) NCT02571036 (2) NCT00834665 (2) NCT00969137 (2) NCT02026011 (2) NCT03622580 (2) NCT03543683 (2) NCT01143493 (2) NCT03671538 (2) NCT04028778 (2) NCT00324961 (2) NCT01915576 (2) NCT02157883 (2) NCT01387022 (2) NCT03864042 (2) NCT03235245 (2) NCT03469960 (2) NCT02795884 (2) NCT00005541 (2) NCT01242813 (2) NCT02906020 (2) NCT03960645 (2) NCT00643058 (2) NCT03443336 (2) NCT02992860 (2) NCT02281760 (2) NCT02201602 (2) NCT04310007 (2) NCT03720665 (2) NCT04309019 (2) NCT00909532 (2) NCT00411944 (2) NCT01604681 (2) NCT01245062 (2) NCT00270231 (2) NCT03256136 (2) NCT03973918 (2) NCT00302692 (2) NCT00125281 (2) NCT02163733 (2) NCT02110407 (2) NCT00475176 (2) NCT03196882 (2) NCT01572818 (2) NCT02556333 (2) NCT04268550 (2) NCT02433717 (2) NCT03428126 (2) NCT01153763 (2) NCT02609776 (2) NCT01420211 (2) NCT03556176 (2) NCT03872440 (2) NCT01405079 (2) NCT03382795 (2) NCT02991950 (2) NCT00013598 (2) NCT03455764 (2) NCT02422628 (2) NCT03831932 (2) NCT03766490 (2) NCT02580474 (2) NCT00499577 (2) NCT02444884 (2) NCT01775943 (2) NCT03544814 (2) NCT01310036 (2) NCT01027663 (2) NCT01928160 (2) NCT01244438 (2) NCT00007150 (2) NCT04462081 (2) NCT02297425 (2) NCT02086071 (2) NCT01050400 (2) NCT03060590 (2) NCT01819428 (2) NCT02709668 (2) NCT02411448 (2) NCT03878719 (2) NCT04479306 (2) NCT03377023 (2) NCT01378026 (2) NCT00226551 (2) NCT03239145 (2) NCT04511533 (2) NCT02191891 (2) NCT04586270 (2) NCT04545710 (2) NCT02120222 (2) NCT02738593 (2) NCT00831272 (2) NCT04469543 (2) NCT00573495 (2) NCT04158544 (2) NCT00904150 (2) NCT02110056 (2) NCT02856893 (2) NCT02110043 (2) NCT02182986 (2) NCT04179890 (2) NCT00063232 (2) NCT02197234 (2) NCT03121235 (2) NCT01532089 (2) NCT03887169 (2) NCT02268864 (2) NCT01963845 (2) NCT00866736 (2) NCT03977194 (2) NCT03991013 (2) NCT02500927 (2) NCT02228382 (2) NCT02689570 (2) NCT01513785 (2) NCT02463435 (2) NCT03351361 (2) NCT04527549 (2) NCT03424759 (2) NCT02197247 (2) NCT02321046 (2) NCT04272034 (2) NCT04027647 (2) NCT02364609 (2) NCT02759835 (2) NCT04349865 (2) NCT00068159 (2) NCT00418015 (2) NCT04310397 (2) NCT03088176 (2) NCT03867175 (2) NCT00339209 (2) NCT00011258 (2) NCT01288430 (2) NCT01616199 (2) NCT03603262 (2) NCT03071705 (2) NCT00969930 (2) NCT00772408 (2) NCT02743468 (2) NCT00277342 (2) NCT04248829 (2) NCT01767454 (2) NCT00933127 (2) NCT03317873 (2) NCT03392246 (2) NCT01909453 (2) NCT03523104 (2) NCT00085917 (2) NCT02507921 (2) NCT03781752 (2) NCT03828422 (2) NCT02193282 (2) NCT03195452 (2) NCT02294487 (2) NCT01325441 (2) NCT02511106 (2) NCT02997501 (2) NCT04184921 (2) NCT00625092 (2) NCT01657786 (2) NCT01415011 (2) NCT02629523 (2) NCT01718847 (2) NCT02818023 (2) NCT00577707 (2) NCT01943422 (2) NCT00116636 (2) NCT01841463 (2) NCT04429542 (2) NCT03865511 (2) NCT01218477 (2) NCT03205267 (2) NCT02881320 (2) NCT01897480 (2) NCT02810990 (2) NCT04189757 (2) NCT01951001 (2) NCT04254939 (2) NCT03207867 (2) NCT00780949 (2) NCT03355768 (2) NCT00817089 (2) NCT02143466 (2) NCT04499053 (2) NCT01907776 (2) NCT00909727 (2) NCT01562028 (2) NCT03737253 (2) NCT00441974 (2) NCT02155465 (2) NCT04586335 (2) NCT00661999 (2) NCT02705339 (2) NCT04006340 (2) NCT04553887 (2) NCT03852290 (2) NCT02183922 (2) NCT03970239 (2) NCT00294372 (2) NCT03250676 (2) NCT03792074 (2) NCT00671892 (2) NCT00689182 (2) NCT00106379 (2) NCT01947023 (2) NCT00509652 (2) NCT03683251 (2) NCT02039986 (2) NCT03515837 (2) NCT04081688 (2) NCT03190005 (2) NCT01584648 (2) NCT02292654 (2) NCT03992456 (2) NCT03133546 (2) NCT01485809 (2) NCT01266967 (2) NCT02909712 (2) NCT00062764 (2) NCT01776684 (2) NCT03042221 (2) NCT01940809 (2) NCT01161537 (2) NCT01154816 (2) NCT01175759 (2) NCT01199731 (2) NCT02788058 (2) NCT03130452 (2) NCT01772732 (2) NCT02631447 (2) NCT02525692 (2) NCT02526537 (2) NCT03513666 (2) NCT02027961 (2) NCT03106779 (2) NCT04106544 (2) NCT04258943 (2) NCT00165984 (2) NCT00977470 (2) NCT02092974 (2) NCT03975231 (2) NCT01998295 (2) NCT03586453 (2) NCT02021305 (2) NCT03135197 (2) NCT00432016 (2) NCT03004625 (2) NCT03851445 (2) NCT04031898 (2) NCT04201418 (2) NCT01911507 (2) NCT03539224 (2) NCT01978236 (2) NCT00866177 (2) NCT00320879 (2) NCT00044304 (2) NCT01999179 (2) NCT00977730 (2) NCT02491775 (2) NCT00212147 (2) NCT02040064 (2) NCT00489385 (2) NCT01713023 (2) NCT04122729 (2) NCT03994393 (2) NCT02438722 (2) NCT02762448 (2) NCT00071903 (2) NCT00626223 (2) NCT01193829 (2) NCT03239340 (2) NCT02991274 (2) NCT02811354 (2) NCT03416530 (2) NCT02522988 (2) NCT00953706 (2) NCT02346955 (2) NCT03795688 (2) NCT02011945 (2) NCT00857675 (2) NCT00028262 (2) NCT02355431 (2) NCT02495233 (2) NCT04575415 (2) NCT03468985 (2) NCT00230087 (2) NCT02017600 (2) NCT04146298 (2) 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NCT01647711 (1) NCT03231722 (1) NCT03576937 (1) NCT04412070 (1) NCT00554866 (1) NCT03151161 (1) NCT01817166 (1) NCT02220855 (1) NCT02512627 (1) NCT04591197 (1) NCT03402048 (1) NCT04500704 (1) NCT02323724 (1) NCT01166126 (1) NCT03029858 (1) NCT04317599 (1) NCT00300573 (1) NCT00809211 (1) NCT01393730 (1) NCT02318368 (1) NCT02228369 (1) NCT01074398 (1) NCT04500717 (1) NCT03134131 (1) NCT01004497 (1) NCT02455167 (1) NCT02073279 (1) NCT02117817 (1) NCT00323687 (1) NCT01605981 (1) NCT01371955 (1) NCT04147767 (1) NCT04144257 (1) NCT03490123 (1) NCT04423185 (1) NCT02625337 (1) NCT03567629 (1) NCT03360929 (1) NCT00109278 (1) NCT04108156 (1) NCT02132598 (1) NCT00542451 (1) NCT01587573 (1) NCT00868465 (1) NCT01494402 (1) NCT00867139 (1) NCT03363139 (1) NCT01936051 (1) NCT02341131 (1) NCT00037076 (1) NCT00582907 (1) NCT02169869 (1) NCT03284684 (1) NCT04204473 (1) NCT01074359 (1) NCT01400191 (1) NCT04530565 (1) NCT03530319 (1) NCT04146402 (1) NCT02658682 (1) NCT04241835 (1) NCT03133234 (1) 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SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT04001803

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Qualitative Hybrid III Implementation Study to Identify and Evaluate Strategies for Successful Implementation of the Cabotegravir + Rilpivirine Long-acting Injectable Regimen in the US

Chronic human immunodeficiency virus (HIV) infection in adults continues to be characterized by increased development of resistant virus, increased transmission of resistant virus and issues associated with the long-term toxicity of anti-retroviral therapy (ART), despite advances in development of new ART, which provides extensive insight in management of HIV-infected individuals. Cabotegravir (CAB) is a potent integrase inhibitor (INI) and rilpivirine (RPV) is a potent non-nucleoside reverse transcriptase inhibitor (NNRTI). A two-drug regimen (DR)with CAB plus RPV long acting (LA) product offers many potential advantages over daily oral regimens including better tolerability, improved compliance, adherence, less likely to develop resistance, and overall treatment satisfaction in virologically suppressed subjects. This is a single-arm, open-label, multicenter, short term facilitation study to evaluate the effect of an implementation strategy on the degree of acceptability, appropriateness, feasibility, fidelity and sustainability of clinical practices to deliver the CAB+RPV LA regimen to HIV infected subjects and to also measure subject satisfaction by recording timeliness of visits, length of visit and their education. Approximately 135 subjects will be enrolled in the study and the total duration of the study will be approximately 52-weeks.

NCT04001803 HIV Infections
MeSH:HIV Infections

1 Interventions

Name: CAB LA+RPV LA

Description: Subjects will receive one tablet of CAB 30 milligram(mg) + RPV 25 mg once daily from Day 1 for 1 month. During month 1, subjects will receive 600 mg of CAB LA injection+ 900 mg of RPV LA injection. Following Month 1, subjects will receive 400mg of CAB LA + 600mg of RPV LA at each subsequent injection.
Type: Drug
Group Labels: 1

Subjects with HIV infection


Primary Outcomes

Description: The responses for acceptability will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes.

Measure: Change from Baseline in the acceptability of intervention measure (AIM) questionnaire in staff study subjects based on Likert scale

Time: Baseline and 4 months

Description: The responses for acceptability will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes.

Measure: Change from Baseline for AIM in staff study subjects

Time: Baseline and 12 months

Description: The responses for acceptability will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes.

Measure: Change from Baseline for AIM in subjects with HIV infection at 4 months

Time: Baseline and 4 months

Description: The responses for acceptability will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes.

Measure: Change from Baseline for AIM in subjects with HIV infection

Time: Baseline and 12 months

Description: The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes.

Measure: Change from Baseline for intervention appropriateness measure (IAM) in staff study subjects at 4 months

Time: Baseline and 4 months

Description: The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes.

Measure: Change from Baseline for IAM in staff study subjects

Time: Baseline and 12 months

Description: The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes.

Measure: Change from Baseline for IAM in subjects with HIV infection

Time: Baseline and 12 months

Description: The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes.

Measure: Change from Baseline for IAM in subjects with HIV infection at 4 months

Time: Baseline and 4 months

Description: The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes.

Measure: Change from Baseline for feasibility of intervention measure (FIM) in staff study subjects at 4 months

Time: Baseline and 4 months

Description: The responses for feasibility will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes.

Measure: Change from Baseline for FIM in staff study subjects

Time: Baseline and 12 months

Secondary Outcomes

Description: The organizational facilitators and barriers are assessed using consolidated framework for implementation research (CFIR). CFIR comprises of 39 constructs organized into 5 domains.

Measure: Change from Baseline for facilitators using semi-structure interview (SSI) in staff study subjects at 4 months

Time: Baseline and 4 months

Description: The organizational facilitators and barriers are assessed using consolidated framework for implementation research (CFIR). CFIR comprises of 39 constructs organized into 5 domains.

Measure: Change from Baseline for facilitators using SSI in staff study subjects

Time: Baseline and 12 months

Description: The organizational facilitators and barriers are assessed using CFIR. CFIR comprises of 39 constructs organized into 5 domains.

Measure: Change from Baseline for barriers using SSI in staff study subjects at 4 months

Time: Baseline and 4 months

Description: The organizational facilitators and barriers are assessed using CFIR. CFIR comprises of 39 constructs organized into 5 domains.

Measure: Change from Baseline for barriers using SSI in staff study subjects

Time: Baseline and 12 months

Description: The organizational facilitators and barriers are assessed using CFIR. CFIR comprises of 39 constructs organized into 5 domains.

Measure: Change from Baseline for facilitators using SSI in subjects with HIV infection

Time: Baseline and 12 months

Description: The organizational facilitators and barriers are assessed using CFIR. CFIR comprises of 39 constructs organized into 5 domains.

Measure: Change from Baseline for barriers using SSI in subjects with HIV infection

Time: Baseline and 12 months

Description: The barriers will be assessed by short-term facilitation like coaching calls which will include combination of structured and open-ended questions.

Measure: Number of barriers assessed among clinics using short-term facilitation

Time: Up to 6 months

Description: The facilitators will be assessed by short-term facilitation like coaching calls which will include combination of structured and open-ended questions.

Measure: Number of facilitators assessed among clinics using short-term facilitation

Time: Up to 6 months

Description: The best practice sharing among clinics will be assessed by short-term facilitation like coaching calls which will include combination of structured and open-ended questions.

Measure: Number of best practices sharing assessed among clinics using short-term facilitation

Time: Up to 6 months

Description: The use of support materials/toolkit will be assessed using survey responses to a series of questions.

Measure: Change from Baseline for the use of support materials/tool kit of staff study subjects at 4 months

Time: Baseline and 4 months

Description: The use of support materials/toolkit will be assessed using survey responses to a series of questions.

Measure: Change from Baseline for the use of support materials/tool kit of staff study subjects

Time: Baseline and 12 months

Description: The use of support materials/toolkit will be assessed using survey responses to a series of questions.

Measure: Change from Baseline for the use of support materials/toolkit of subjects with HIV infection at 4 months

Time: Baseline and 4 months

Description: The use of support materials/toolkit will be assessed using survey responses to a series of questions.

Measure: Change from Baseline for the use of support materials/toolkit of subjects with HIV infection

Time: Baseline and 12 months

Description: The use of support materials/toolkit will be assessed through SSI.

Measure: Number of support materials/toolkit used by staff study subjects

Time: Up to 12 months

Description: The implementation of fidelity will be assessed using SSI from the validated CFIR framework.

Measure: Number of subjects receiving injections within target window at 4 months

Time: Baseline and 4 months

Description: The implementation of fidelity will be assessed using SSI from the validated CFIR framework.

Measure: Number of subjects receiving injections within target window

Time: Up to 12 months

Description: The implementation sustainability in staff study subjects will be assessed using PSAT tool. This tool evaluates the capability of clinics to maintain processes developed to administer CAB+RPV injection in routine clinical settings after conclusion of the study.

Measure: Implementation sustainability assessed in staff study subjects using program sustainability assessment tool (PSAT)

Time: At month 12

Description: Subject survey responses will be assessed to measure subject satisfaction by calculating timelines of visit, length of visit and subject education.

Measure: Number of survey responses with subject satisfaction at month 1

Time: At month 1

Description: Subject survey responses will be assessed to measure subject satisfaction by calculating timelines of visit, length of visit and subject education.

Measure: Number of survey responses with subject satisfaction at month 4

Time: At month 4

Description: Subject survey responses will be assessed to measure subject satisfaction by calculating timelines of visit, length of visit and subject education.

Measure: Number of survey responses with subject satisfaction at month 12

Time: At months 12

Description: The timeliness of visit for each subject will be assessed using SSI responses.

Measure: Change from Baseline in subject's timeliness of visit

Time: Baseline and at month 12

Description: The length of hospital visit for each subject will be assessed using SSI responses

Measure: Change from Baseline in subject's length of visit

Time: Baseline and at month 12

Description: The subject's knowledge about CAB + RPV LA treatment will be assessed using SSI responses

Measure: Change from Baseline in subject's knowledge about the CAB + RPV LA treatment

Time: Baseline and at month 12

Description: The length of subject visit will be assessed from arrival until departure from clinic.

Measure: Length of subject visit

Time: At month 1

Description: The length of subject visit will be assessed from arrival until departure from clinic.

Measure: Length of subject visit

Time: At month 5

Description: The length of subject visit will be assessed from arrival until departure from clinic.

Measure: Length of subject visit

Time: At month 11

Description: Plasma samples will be collected from the subject at specific time points. The Abbott RealTime HIV-1 Assay lower limit of detection (LLOD) 40 c/mL, will be used.

Measure: Number of subjects with plasma HIV-1 Ribo Nucleic Acid (RNA)<50 copies/milliliter (c/mL)

Time: Up to 12 months

Description: CVF is defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/mL after prior suppression to <200 c/mL.

Measure: Number of subjects with confirmed virologic failure (CVF)

Time: Up to 12 months

Description: Blood samples will be collected and used for the analysis of genotypic resistance in subjects with CVF.

Measure: Number of subjects with treatment emergent genotypic resistance to CAB and RPV

Time: Up to 12 months

Description: Blood samples will be collected and used for the analysis of phenotypic resistance in subjects with CVF.

Measure: Number of subjects with phenotypic resistance to CAB and RPV

Time: Up to 12 months

Description: An AE is any untoward medical occurrence in a subject or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect and other situations which involve medical or scientific judgment, and is associated with liver injury and impaired liver function.

Measure: Number of subjects with adverse events (AEs) and serious adverse events (SAEs)

Time: Up to 12 months

Description: An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of subjects who will discontinue the treatment due to AEs will be reported.

Measure: Number of subjects who discontinue treatment due to AEs over time

Time: Up to 12 months

Description: Blood samples will be collected to measure platelets, red blood cells (RBC) count, white blood cells (WBC) count (absolute), hemoglobin, hematocrit, mean corpuscular volume (MCV), neutrophils, lymphocytes, monocytes, eosinophils and basophils.

Measure: Number of subjects with abnormal hematology findings

Time: Up to 12 months

Description: Blood samples will be collected to measure blood urea nitrogen (BUN), creatinine, glucose, sodium, potassium, chloride, Total carbon dioxide (CO2), lipase, phosphate, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase (ALP), total bilirubin, albumin, creatine phosphokinase (CK) and creatinine clearance.

Measure: Number of subjects with abnormal clinical chemistry findings

Time: Up to 12 months

Description: Urine samples will be collected and analyzed from subjects at indicated time points.

Measure: Number of subjects with abnormal urinalysis

Time: Up to 12 months

Description: The ISRs will be assessed through-out the study. All ISRs that are either serious, grade 3 or higher or persisting beyond 2 weeks will be discussed with the Medical Monitor to determine etiology and assess appropriate continued study participation.

Measure: Number of subjects with injection site reactions (ISRs) over time

Time: Up to 12 months

Description: Blood samples will be collected to measure hematology parameters including: platelet count, WBC count, basophil count, eosinophil count, lymphocyte count , monocyte count and neutrophil count.

Measure: Change from Baseline in hematology parameters of platelet count, WBC count, basophil count, eosinophil count, lymphocyte count , monocyte count and neutrophil count (all 10^9 cells/Liter)

Time: Baseline and Up to 12 months

Description: Blood samples will be collected to measure RBC count.

Measure: Change from Baseline in hematology parameters-RBC count

Time: Baseline and Up to 12 months

Description: Blood samples will be collected to measure Hemoglobin.

Measure: Change from Baseline in hematology parameters- Hemoglobin

Time: Baseline and Up to 12 months

Description: Blood samples will be collected to measure hematocrit.

Measure: Change from Baseline in hematology parameter-hematocrit

Time: Baseline and Up to 12 months

Description: Blood samples will be collected to measure MCV.

Measure: Change from Baseline in hematology parameter-MCV

Time: Baseline and Up to 12 months

Description: Blood samples will be collected to measure sodium, potassium, carbon-dioxide, chloride, and glucose.

Measure: Change from Baseline in clinical laboratory parameters of sodium, potassium, carbon-dioxide, chloride and glucose (all millimoles per liter)

Time: Baseline and Up to 12 months

Description: Blood samples will be collected to measure creatinine and total bilirubin

Measure: Change from Baseline in clinical laboratory parameters of creatinine and total bilirubin

Time: Baseline and Up to 12 months

Description: Blood samples will be collected to measure ALT, ALP and AST.

Measure: Change from Baseline in clinical laboratory parameters of ALT, ALP and AST

Time: Baseline and Up to 12 months

Description: Blood samples will be collected to measure Creatine phosphokinase.

Measure: Change from Baseline in clinical laboratory parameter-Creatine phosphokinase

Time: Baseline and Up to 12 months

Description: Blood samples will be collected to measure Creatinine clearance

Measure: Change from Baseline in clinical laboratory parameter-Creatinine clearance

Time: Baseline and Up to 12 months

Description: Blood samples will be collected to measure lipase.

Measure: Change from Baseline in clinical laboratory parameter-lipase

Time: Baseline and Up to 12 months

Description: Blood samples will be collected to measure BUN.

Measure: Change from Baseline in clinical laboratory parameters-BUN

Time: Baseline and Up to 12 months

Description: Urine samples will be collected at the specified timepoints, for assessment of urine albumin to creatinine ratio.

Measure: Change from Baseline in urinalysis parameters, urine albumin to creatinine ratio

Time: Baseline and Up to 12 months

Description: Urine samples will be collected at the specified timepoints, for assessment of urine protein to creatinine ratio.

Measure: Change from Baseline in urinalysis parameters, urine protein to creatinine ratio

Time: Baseline and Up to 12 months

Description: Urine samples will be collected at the specified timepoints, for assessment of urine phosphate.

Measure: Change from Baseline in urinalysis parameters, urine phosphate

Time: Baseline and Up to 12 months

Purpose: Other

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 K103N

- Any evidence of primary resistance based on the presence of any major known INI or NNRTI resistance-associated mutation, except for K103N, (International acquired immune deficiency syndrome [AIDS] Society [IAS]-USA) by any historical resistance test result. --- K103N ---



HPO Nodes