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1. Week 96 results of the randomized, multicentre Maraviroc Switch (MARCH) study

Author

Pett, SL, Amin, J, Horban, A, Andrade-Villanueva, J, Losso, M, Porteiro, N, Madero, JS, Belloso, W, Tu, E, Silk, D, Kelleher, A, Harrigan, R, Clark, A, Sugiura, W, Wolff, M, Gill, J, Gatell, J, Clarke, A, Ruxrungtham, K, Prazuck, T, Kaiser, R, Woolley, I, Alberto Arnaiz, J, Cooper, D, Rockstroh, JK, Mallon, P, Emery, S, Fisher, M, Rockstroh, J, Stellbrink, J, Merlin, K, Yeung, J, Fsadni, B, Marks, K, Suzuki, K, Rismanto, N, Salomon, H, Rubio, AE, Chibo, D, Birch, C, Swenson, L, Chan, D, Berg, T, Obermeier, M, Schuelter, E, Aragon, SS, Luebke, N, Coughlan, S, Dean, J, Iwatani, Y, Teran, GR, Avila, S, Sirivichayakul, S, Naphassanant, M, Ubolyam, S, Kaye, S, Land, S, Walker, S, Haubrich, R, DeJesus, E, Berthon-Jones, N, Espinosa, N, Courtney-Vega, K, Absar, N, Haskelberg, H, Robson, R, Donaldson, A, Guelman, D, Gambardella, L, Valdovinos, M, Arnaiz, J, Beleta, H, Ramos, N, Targa, M, Späth, B, Boesecke, C, Engelhardt, A, Perry, N, Beckthold, B, Drummond, F, Lefevre, E, Corr, S, Grant, C, Lupo, S, Peroni, L, Sanchez, M, De Paz Sierra, M, Viloria, G, Parlante, A, Bissio, E, Luchetti, P, Confalonieri, V, Warley, E, Vieni, I, Vilas, C, Zarate, A, Mayer, G, Elliot, J, Hagenauer, M, Kelley, M, Pett, SL, Amin, J, Horban, A, Andrade-Villanueva, J, Losso, M, Porteiro, N, Madero, JS, Belloso, W, Tu, E, Silk, D, Kelleher, A, Harrigan, R, Clark, A, Sugiura, W, Wolff, M, Gill, J, Gatell, J, Clarke, A, Ruxrungtham, K, Prazuck, T, Kaiser, R, Woolley, I, Alberto Arnaiz, J, Cooper, D, Rockstroh, JK, Mallon, P, Emery, S, Fisher, M, Rockstroh, J, Stellbrink, J, Merlin, K, Yeung, J, Fsadni, B, Marks, K, Suzuki, K, Rismanto, N, Salomon, H, Rubio, AE, Chibo, D, Birch, C, Swenson, L, Chan, D, Berg, T, Obermeier, M, Schuelter, E, Aragon, SS, Luebke, N, Coughlan, S, Dean, J, Iwatani, Y, Teran, GR, Avila, S, Sirivichayakul, S, Naphassanant, M, Ubolyam, S, Kaye, S, Land, S, Walker, S, Haubrich, R, DeJesus, E, Berthon-Jones, N, Espinosa, N, Courtney-Vega, K, Absar, N, Haskelberg, H, Robson, R, Donaldson, A, Guelman, D, Gambardella, L, Valdovinos, M, Arnaiz, J, Beleta, H, Ramos, N, Targa, M, Späth, B, Boesecke, C, Engelhardt, A, Perry, N, Beckthold, B, Drummond, F, Lefevre, E, Corr, S, Grant, C, Lupo, S, Peroni, L, Sanchez, M, De Paz Sierra, M, Viloria, G, Parlante, A, Bissio, E, Luchetti, P, Confalonieri, V, Warley, E, Vieni, I, Vilas, C, Zarate, A, Mayer, G, Elliot, J, Hagenauer, M, and Kelley, M

Abstract

Objectives: The Maraviroc Switch (MARCH) study week 48 data demonstrated that maraviroc, a chemokine receptor-5 (CCR5) inhibitor, was a safe and effective switch for the ritonavir-boosted protease inhibitor (PI/r) component of a two nucleos(t)ide reverse transcriptase inhibitor [N(t)RTI] plus PI/r-based antiretroviral regimen in patients with R5-tropic virus. Here we report the durability of this finding. Methods: MARCH, an international, multicentre, randomized, 96-week open-label switch study, enrolled HIV-1-infected adults with R5-tropic virus who were stable (> 24 weeks) and virologically suppressed [plasma viral load (pVL) < 50 HIV-1 RNA copies/mL]. Participants were randomized to continue their current PI/r-based regimen (PI/r) or to switch to MVC plus two N(t)RTIs (MVC) (1:2 randomization). The primary endpoint was the difference in the proportion with pVL < 200 copies/mL at 96 weeks. The switch arm was defined as noninferior if the lower limit of the 95% confidence interval (CI) for the difference was < −12% in the intention-to-treat (ITT) population. Safety endpoints (the difference in the mean change from baseline or a comparison of proportions) were analysed as key secondary endpoints. Results: Eighty-two (PI/r) and 156 (MVC) participants were randomized and included in the ITT analysis; 71 (87%) and 130 (83%) were in follow-up and on therapy at week 96. At week 96, 89.0% and 90.4% in the PI/r and MVC arms, respectively, had pVL < 50 copies/mL (95% CI -6.6, 10.2). Moreover, in those switching away from PI/r, there were significant reductions in mean total cholesterol (differences 0.31 mmol/L; P = 0.02) and triglycerides (difference 0.44 mmol/L; P < 0.001). Changes in CD4 T-cell count, renal function, and serious and nonserious adverse events were similar in the two arms. Conclusions: MVC as a switch for a PI/r is safe and effective at maintaining virological suppression while having significant lipid benefits over 96 weeks.

Published
2018

2. Week 96 results of the randomized, multicentre Maraviroc Switch (MARCH) study.

Author

Beckthold B., Kaye S., Land S., Walker S., Haubrich R., DeJesus E., Berthon-Jones N., Espinosa N., Courtney-Vega K., Absar N., Haskelberg H., Robson R., Donaldson A., Guelman D., Tabrett C., Warzywoda E., MacRae K., Sinclair B., Sinn K., Bloch M., Franic T., Vincent T., Stewart N., Jayewardene A., Dwyer D., Kok J., Assam D., Taylor J., King P., Orth D., Youds D., Sowden D., Johnston C., Murray S., Hehir J., Wadham S., Donohue W., Thompson J., Garsia R., Turnham G., Madden T., Nvene J., Gillies A., Bryant M., Walmsley S., Chan W., LeBlanc R., Lanteigne F., Mouawad R., Rahal I., Guber S., Ozturk S., Smith G., Halpenny R., Reko T., Hills J.R., Allendes G., Hocqueloux F.L., Stephan C., Ebeling F., Spath B., Jensen B.-E.O., Feind C., Meyer-Olson D., Stoll M., Hoeper K., Beider R., Faetkenheur G., Thomas E., Baumgarten A., Ingiliz P., Wienbreyer A., Behrendt D., Nienkarken T., Jessen H., Zedlack C., Simelane S., Assmann J., Ghavami-Kia B., Imahashi M., Tanabe K., Yokomaku Y., Imamura J., de Oca M.M., Gonzalez L., Ponce D., Mendoza A., Sierra-Madero J., Hernandez J.E.S., Ballesteros E.J.R., del Moral Ponce S., Ignatowska A., Bakowska E., Pulik P., Sanz-Moreno J., Paredes R., Puig J., Domingo P., Gutierrez M., Gonzalez-Cordon A., Callau P., Aldeguer J.L., Tovar S.C., Noval M.L., Rivas I., Delgado-Fernandez M., Arribas J.R., Castro J.M., Avihingsanon A., Maek-a-nantawat W., Intasan J., Charoenporn W., Cuprasitrut T., Jaisomkom P., Pruksakaew K., Winston A., Mullaney S., Barbour L., Richardson C., Fox J., Murray T., Teague A., Leen C., Morris S., Satyajit D., Sandhu R., Tucker J., Pett S., Amin J., Horban A., Andrade-Villanueva J., Losso M., Porteiro N., Madero J.S., Belloso W., Tu E., Silk D., Kelleher A., Harrigan R., Clark A., Sugiura W., Wolff M.J., Gill J., Gatell J., Clarke A., Ruxrungtham K., Prazuck T., Kaiser R., Woolley I., Alberto Arnaiz J., Cooper D., Rockstroh J.K., Mallon P., Emery S., Fisher M., Rockstroh J., Stellbrink J., Merlin K., Yeung J., Fsadni B., Marks K., Suzuki K., Rismanto N., Salomon H., Rubio A.E., Chibo D., Birch C., Swenson L., Chan D., Berg T., Obermeier M., Schuelter E., Aragon S.S., Luebke N., Coughlan S., Dean J., Iwatani Y., Teran G.R., Avila S., Sirivichayakul S., Naphassanant M., Ubolyam S., Gambardella L., Valdovinos M., Arnaiz J., Beleta H., Ramos N., Targa M., Boesecke C., Engelhardt A., Perry N., Drummond F., Lefevre E., Corr S., Grant C., Lupo S., Peroni L., Sanchez M., De Paz Sierra M., Viloria G., Parlante A., Bissio E., Luchetti P., Confalonieri V., Warley E., Vieni I., Vilas C., Zarate A., Mayer G., Elliot J., Hagenauer M., Kelley M., Rowling D., Gibson A., Latch N., Beckthold B., Kaye S., Land S., Walker S., Haubrich R., DeJesus E., Berthon-Jones N., Espinosa N., Courtney-Vega K., Absar N., Haskelberg H., Robson R., Donaldson A., Guelman D., Tabrett C., Warzywoda E., MacRae K., Sinclair B., Sinn K., Bloch M., Franic T., Vincent T., Stewart N., Jayewardene A., Dwyer D., Kok J., Assam D., Taylor J., King P., Orth D., Youds D., Sowden D., Johnston C., Murray S., Hehir J., Wadham S., Donohue W., Thompson J., Garsia R., Turnham G., Madden T., Nvene J., Gillies A., Bryant M., Walmsley S., Chan W., LeBlanc R., Lanteigne F., Mouawad R., Rahal I., Guber S., Ozturk S., Smith G., Halpenny R., Reko T., Hills J.R., Allendes G., Hocqueloux F.L., Stephan C., Ebeling F., Spath B., Jensen B.-E.O., Feind C., Meyer-Olson D., Stoll M., Hoeper K., Beider R., Faetkenheur G., Thomas E., Baumgarten A., Ingiliz P., Wienbreyer A., Behrendt D., Nienkarken T., Jessen H., Zedlack C., Simelane S., Assmann J., Ghavami-Kia B., Imahashi M., Tanabe K., Yokomaku Y., Imamura J., de Oca M.M., Gonzalez L., Ponce D., Mendoza A., Sierra-Madero J., Hernandez J.E.S., Ballesteros E.J.R., del Moral Ponce S., Ignatowska A., Bakowska E., Pulik P., Sanz-Moreno J., Paredes R., Puig J., Domingo P., Gutierrez M., Gonzalez-Cordon A., Callau P., Aldeguer J.L., Tovar S.C., Noval M.L., Rivas I., Delgado-Fernandez M., Arribas J.R., Castro J.M., Avihingsanon A., Maek-a-nantawat W., Intasan J., Charoenporn W., Cuprasitrut T., Jaisomkom P., Pruksakaew K., Winston A., Mullaney S., Barbour L., Richardson C., Fox J., Murray T., Teague A., Leen C., Morris S., Satyajit D., Sandhu R., Tucker J., Pett S., Amin J., Horban A., Andrade-Villanueva J., Losso M., Porteiro N., Madero J.S., Belloso W., Tu E., Silk D., Kelleher A., Harrigan R., Clark A., Sugiura W., Wolff M.J., Gill J., Gatell J., Clarke A., Ruxrungtham K., Prazuck T., Kaiser R., Woolley I., Alberto Arnaiz J., Cooper D., Rockstroh J.K., Mallon P., Emery S., Fisher M., Rockstroh J., Stellbrink J., Merlin K., Yeung J., Fsadni B., Marks K., Suzuki K., Rismanto N., Salomon H., Rubio A.E., Chibo D., Birch C., Swenson L., Chan D., Berg T., Obermeier M., Schuelter E., Aragon S.S., Luebke N., Coughlan S., Dean J., Iwatani Y., Teran G.R., Avila S., Sirivichayakul S., Naphassanant M., Ubolyam S., Gambardella L., Valdovinos M., Arnaiz J., Beleta H., Ramos N., Targa M., Boesecke C., Engelhardt A., Perry N., Drummond F., Lefevre E., Corr S., Grant C., Lupo S., Peroni L., Sanchez M., De Paz Sierra M., Viloria G., Parlante A., Bissio E., Luchetti P., Confalonieri V., Warley E., Vieni I., Vilas C., Zarate A., Mayer G., Elliot J., Hagenauer M., Kelley M., Rowling D., Gibson A., and Latch N.

Abstract

Objectives: The Maraviroc Switch (MARCH) study week 48 data demonstrated that maraviroc, a chemokine receptor-5 (CCR5) inhibitor, was a safe and effective switch for the ritonavir-boosted protease inhibitor (PI/r) component of a two nucleos(t)ide reverse transcriptase inhibitor [N(t)RTI] plus PI/r-based antiretroviral regimen in patients with R5-tropic virus. Here we report the durability of this finding. Method(s): MARCH, an international, multicentre, randomized, 96-week open-label switch study, enrolled HIV-1-infected adults with R5-tropic virus who were stable (> 24 weeks) and virologically suppressed [plasma viral load (pVL) < 50 HIV-1 RNA copies/mL]. Participants were randomized to continue their current PI/r-based regimen (PI/r) or to switch to MVC plus two N(t)RTIs (MVC) (1:2 randomization). The primary endpoint was the difference in the proportion with pVL < 200 copies/mL at 96 weeks. The switch arm was defined as noninferior if the lower limit of the 95% confidence interval (CI) for the difference was < -12% in the intention-to-treat (ITT) population. Safety endpoints (the difference in the mean change from baseline or a comparison of proportions) were analysed as key secondary endpoints. Result(s): Eighty-two (PI/r) and 156 (MVC) participants were randomized and included in the ITT analysis; 71 (87%) and 130 (83%) were in follow-up and on therapy at week 96. At week 96, 89.0% and 90.4% in the PI/r and MVC arms, respectively, had pVL < 50 copies/mL (95% CI -6.6, 10.2). Moreover, in those switching away from PI/r, there were significant reductions in mean total cholesterol (differences 0.31 mmol/L; P = 0.02) and triglycerides (difference 0.44 mmol/L; P < 0.001). Changes in CD4 T-cell count, renal function, and serious and nonserious adverse events were similar in the two arms. Conclusion(s): MVC as a switch for a PI/r is safe and effective at maintaining virological suppression while having significant lipid benefits over 96 weeks.Copyright © 2017 British H

Published
2017

3. Efficacy and safety of efavirenz 400 mg daily versus 600 mg daily: 96-week data from the randomised, double-blind, placebo-controlled, non-inferiority ENCORE1 study

Author

Amin, J, Becker, S, Belloso, W, Boffito, M, Cooper, D, Crabtree-Ramirez, B, Duncombe, C, Foulkes, S, Hill, A, Jessen, H, Kumar, S, Lee, MP, Nwizu, C, Read, T, Rooney, J, Schaffer, K, Shahar, E, Winston, A, Wolff, M, Young, B, Abela, C, Avihingsanon, A, Boyd, M, Carey, D, Clarke, A, Courtney-Vega, K, Delfino, M, Donaldson, A, Emery, S, Espinosa, N, Johannesen, T, Lin, E, Losso, M, Moricz, A, Pett, S, Phanupak, P, Puls, R, Pussadee, K, Sutheerasak, P, Tomlins, L, Ubolyam, S, bin Raja Azwa, RIS, Bissio, E, Calanni, L, Chetchotisakd, P, Doong, N, Elliott, J, Gazzard, B, Kelly, M, Laplume, H, del Carmen Luna, N, Lupo, S, Messina, OG, Mohapi, L, Moore, R, Nolan, D, Orrell, C, Perez, C, Phanuphak, P, Rockstroh, J, Rowling, D, Supparatpinyo, K, Smith, D, Villanueva, JA, Vlahakis, E, Kelleher, T, Cunningham, P, Merlin, K, Yeung, J, Shaik, A, Fsadni, B, Carrera, A, Lograsso, M, Gulick, R, Dunn, D, Dolan, M, Amin, J, Becker, S, Belloso, W, Boffito, M, Cooper, D, Crabtree-Ramirez, B, Duncombe, C, Foulkes, S, Hill, A, Jessen, H, Kumar, S, Lee, MP, Nwizu, C, Read, T, Rooney, J, Schaffer, K, Shahar, E, Winston, A, Wolff, M, Young, B, Abela, C, Avihingsanon, A, Boyd, M, Carey, D, Clarke, A, Courtney-Vega, K, Delfino, M, Donaldson, A, Emery, S, Espinosa, N, Johannesen, T, Lin, E, Losso, M, Moricz, A, Pett, S, Phanupak, P, Puls, R, Pussadee, K, Sutheerasak, P, Tomlins, L, Ubolyam, S, bin Raja Azwa, RIS, Bissio, E, Calanni, L, Chetchotisakd, P, Doong, N, Elliott, J, Gazzard, B, Kelly, M, Laplume, H, del Carmen Luna, N, Lupo, S, Messina, OG, Mohapi, L, Moore, R, Nolan, D, Orrell, C, Perez, C, Phanuphak, P, Rockstroh, J, Rowling, D, Supparatpinyo, K, Smith, D, Villanueva, JA, Vlahakis, E, Kelleher, T, Cunningham, P, Merlin, K, Yeung, J, Shaik, A, Fsadni, B, Carrera, A, Lograsso, M, Gulick, R, Dunn, D, and Dolan, M

Abstract

Background: The week 48 primary analysis of the ENCORE1 trial established the virological non-inferiority and safety of efavirenz 400 mg compared with the standard 600 mg dose, combined with tenofovir and emtricitabine, as first-line HIV therapy. This 96-week follow-up of the trial assesses the durability of efficacy and safety of this treatment over 96 weeks. Methods: ENCORE1 was a double-blind, placebo-controlled, non-inferiority trial done at 38 clinical sites in 13 countries. HIV-infected adult patients (≥16 years of age) with no previous antiretroviral therapy, a CD4 cell count of 50-500 cells per μL, and plasma HIV-1 viral load of at least 1000 copies per mL were randomly assigned (1:1) by an electronic case report form to receive fixed-dose daily tenofovir 300 mg and emtricitabine 200 mg plus efavirenz either 400 mg daily or 600 mg daily. Participants, physicians, and all other trial staff were masked to treatment assignment. Randomisation was stratified by HIV-1 viral load at baseline (≤ or >100 000 copies per mL). The primary endpoint was the difference in the proportions of patients in the two treatment groups with a plasma HIV-1 viral load below 200 copies per mL at week 96. Treatment groups were deemed to be non-inferior if the lower limit of the 95% CI for the difference in viral load was above -10% by modified intention-to-treat analysis. Non-inferiority was assessed in the modified intention-to-treat, per-protocol, and non-completer=failure (NC=F) populations. Adverse events and serious adverse events were summarised by treatment group. This study is registered with ClinicalTrials.gov, number NCT01011413. Findings: Between Aug 24, 2011, and March 19, 2012, 636 eligible participants were enrolled and randomly assigned to the two treatment groups (324 to efavirenz 400 mg and 312 to efavirenz 600 mg). The intention-to-treat population who received at least one dose of study drug comprised 630 patients: 321 in the efavirenz 400 mg group and 309 in the efa

Published
2015

4. Efficacy of 400 mg efavirenz versus standard 600 mg dose in HIV-infected, antiretroviral-naive adults (ENCORE1): A randomised, double-blind, placebo-controlled, non-inferiority trial

Author

Amin, J, Becker, S, Belloso, W, Boffito, M, Cooper, D, Crabtree-Ramirez, B, Duncombe, C, Emery, S, Foulkes, S, Hill, A, Jessen, H, Kumar, S, Lee, MP, Losso, M, Nwizu, C, Phanuphak, P, Ripin, D, Read, T, Rooney, J, Schaffer, K, Shahar, E, Winston, A, Wolff, M, Young, B, Abela, C, Boyd, M, Carey, D, Clarke, A, Courtney-Vega, K, Dazo, C, Delfino, M, Donaldson, A, Espinosa, N, Johannesen, T, Kaew-On, P, Lin, E, Moricz, A, Taylor, J, Phanupak, P, Puls, RL, Pussadee, K, Sutheerasak, P, Tomkins, L, Ubolyam, S, Shah Bin Raja Azwa, RI, Bissio, E, Calanni, L, Casiro, A, Chetchotisakd, P, Contarelli, J, Doong, N, Elliott, J, Gazzard, B, Kelly, M, Del Carmen Luna, N, Lupo, S, Messina, OG, Mohapi, L, Moore, R, Nolan, D, Orrell, C, Perez, C, Pett, S, Rockstroh, J, Supparatpinyo, K, Smith, D, Villanueva, JA, Vlahakis, E, Kelleher, T, Cunningham, P, Merlin, K, Yeung, J, Shaik, A, Fsadni, B, Carrera, A, Lograsso, M, Gulick, R, Crabtree-Ramiraz, B, Winston, E, Dunn, D, Dolan, M, Amin, J, Becker, S, Belloso, W, Boffito, M, Cooper, D, Crabtree-Ramirez, B, Duncombe, C, Emery, S, Foulkes, S, Hill, A, Jessen, H, Kumar, S, Lee, MP, Losso, M, Nwizu, C, Phanuphak, P, Ripin, D, Read, T, Rooney, J, Schaffer, K, Shahar, E, Winston, A, Wolff, M, Young, B, Abela, C, Boyd, M, Carey, D, Clarke, A, Courtney-Vega, K, Dazo, C, Delfino, M, Donaldson, A, Espinosa, N, Johannesen, T, Kaew-On, P, Lin, E, Moricz, A, Taylor, J, Phanupak, P, Puls, RL, Pussadee, K, Sutheerasak, P, Tomkins, L, Ubolyam, S, Shah Bin Raja Azwa, RI, Bissio, E, Calanni, L, Casiro, A, Chetchotisakd, P, Contarelli, J, Doong, N, Elliott, J, Gazzard, B, Kelly, M, Del Carmen Luna, N, Lupo, S, Messina, OG, Mohapi, L, Moore, R, Nolan, D, Orrell, C, Perez, C, Pett, S, Rockstroh, J, Supparatpinyo, K, Smith, D, Villanueva, JA, Vlahakis, E, Kelleher, T, Cunningham, P, Merlin, K, Yeung, J, Shaik, A, Fsadni, B, Carrera, A, Lograsso, M, Gulick, R, Crabtree-Ramiraz, B, Winston, E, Dunn, D, and Dolan, M

Abstract

Background: The optimum dose of key antiretroviral drugs is often overlooked during product development. The ENCORE1 study compared the efficacy and safety of reduced dose efavirenz with standard dose efavirenz in combination with tenofovir and emtricitabine as first-line treatment for HIV infection. An effective and safe reduced dose could yield meaningful cost savings. Methods: ENCORE1 is a continuing non-inferiority trial in HIV-1-infected antiretroviral-naive adults in 38 clinical sites in 13 countries. Participants (plasma HIV-RNA >1000 log10 copies per mL, CD4 T-cell count 50-500 cells per μL) were randomly assigned by a computer-generated sequence with a blocking factor of four (stratified by clinical site and by screening viral load) to receive tenofovir plus emtricitabine with either a reduced daily dose (400 mg) or a standard dose (600 mg) of efavirenz. Participants, physicians, and all other trial staffwere masked to treatment group. The primary endpoint was the difference in proportions of participants with plasma HIV-RNA of less than 200 copies per mL at 48 weeks. Treatment groups were regarded as non-inferior if the lower limit of the 95% CI for the difference in viral load was less than-10% by modified intention-to-treat analysis. Adverse events were summarised by treatment. This trial is registered with ClinicalTrials.gov, number NCT01011413. Findings: The modified intention-to-treat analysis consisted of 630 patients (efavirenz 400=321; efavirenz 600=309). 32% were women; 37% were African, 33% were Asian, and 30% were white. The mean baseline CD4 cell count was 273 cells per μL (SD 99) and median plasma HIV-RNA was 4.75 log 10 copies per mL (IQR 0.88). The proportion of participants with a viral load below 200 copies per mL at week 48 was 94.1% for efavirenz 400 mg and 92.2% for 600 mg (difference 1.85%, 95% CI-2.1 to 5.79). CD4 T-cell counts at week 48 were significantly higher for the 400 mg group than for the 600 mg group (mean difference 25 cell

Published
2014

5. Assessing site performance in the Altair study, a multinational clinical trial.

Author

Berthon-Jones N, Courtney-Vega K, Donaldson A, Haskelberg H, Emery S, and Puls R

Subjects
Antiretroviral Therapy, Highly Active, Asia, Australia, Benchmarking, Clinical Protocols, Europe, HIV Infections diagnosis, Humans, Intention to Treat Analysis, Latin America, North America, Patient Selection, Quality Control, Quality Indicators, Health Care, Sample Size, Time Factors, Anti-HIV Agents therapeutic use, Contracts standards, Ethics Committees, Research standards, HIV Infections drug therapy, Research Design standards
Abstract

Background: Reviewing clinical trial site performance identifies strategies to control outcomes. Performance across 5 geographical regions (36 sites across Asia, Australia, Europe, North America and Latin America) was investigated in a study that randomised 322 HIV-infected individuals., Methods: Regional performance was compared using descriptive analysis for time to site opening, recruitment, quality of data and laboratory samples. Follow-up consisted of 10 visits (96 weeks), electronic data collection (EDC) within 7 days of a visit and serious adverse events (SAEs) reported within 24 hours of site awareness., Results: Median days to site opening was 250 (188 to 266), ranging from 177 (158 to 200) (Australia) to 265 (205 to 270) (Europe). Median days to ethics and regulatory approval was 182 (120 to 241) and 218 (182 to 341) days, respectively. Within regions, time to approval ranged from 187 (91 to 205) days (Australia) to 276 (175 to 384) days (Europe). Time to first randomisation ranged from 282 (250 to 313) days (Australia) to 426 (420 to 433) days (North America). Recruitment was lower than forecasted in Asia, Australia, Europe and North America at 89%, 77%, 91% and 43%, respectively. The converse was true in Latin America where despite ethics, regulatory and contractual delays, recruitment was 104% of predicted. Median days to EDC was 7 (3 to 16), ranging from 3 (1 to 16) (Asia) to 13 (8 to 14) days (North America). Median days for initial SAE submission to sponsor was 6 (2 to 20), ranging from 4 (2 to 18) (Latin America) to 24 (5 to 46) days (Australia). Sites took longer to submit final reports, overall median of 28 (7 to 91) days, ranging from 7 days (Australia) to 67 (23 to 103) days (Europe)., Conclusions: Population availability and time to ethics and regulatory approvals influence recruitment; therefore accurate feasibility assessments are critical to site selection. Time to ethics and regulatory approval may not limit site inclusion if compensated by rapid recruitment. Identifying potential delays and methods for reduction can decrease time and costs for sponsors., Trial Registration: Clinical Trials.Gov identifier: NCT00335322. Date of registration: 8 June 2006.

Published
2015
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