Sodium bicarbonate based antacids should not be used in patients on Raltegravir. Maalox or aluminum hydroxide or magnesium hydroxide based antacids should be given 2 hours prior to administration of Raltegravir. Multivitamin is safe to use in patients on Raltegravir.
Raltegravir vs Forceval
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Study Design
Participants received a single dose (sd) of RAL (400 mg tablet), followed Forceval (1tablet) 2 h prior to dosing without food, for 4 study days. The Heidelberg pH diagnostic system was used to collect gastrointestinal pH data. Blood samples and pH measurements were collected at 0, 1, 2, 3, 4, 6, 8, 10 and 12 h post dose. Plasma RAL concentrations were determined by validated LC-MS/MS, and PK parameters were estimated (WinNonLin). The primary endpoint was a change in AUC, C12h, CMAX, or TMAX. Secondary endpoints were safety and tolerability of combinations, and correlation of pH with RAL PK.
Study Results
The multivitamin, Forceval, did not significantly affect the PK of RAL
Study Conclusions
Authors concluded that multivitamin use doesn't change PK of Raltegravir.
References
Reynolds, H, Lewis, J, Egan, D, Mas, C, Else, L, Chiong, J. The effect of antacids and multivitamins on raltegravir . Conference On Retroviruses And Opportunistic Infections. Boston. ; March 2018.
Raltegravir vs Forceval
^
Study Design
Participants received a single dose (sd) of RAL (400 mg tablet), followed Forceval (1tablet) 2 h prior to dosing without food, for 4 study days. The Heidelberg pH diagnostic system was used to collect gastrointestinal pH data. Blood samples and pH measurements were collected at 0, 1, 2, 3, 4, 6, 8, 10 and 12 h post dose. Plasma RAL concentrations were determined by validated LC-MS/MS, and PK parameters were estimated (WinNonLin). The primary endpoint was a change in AUC, C12h, CMAX, or TMAX. Secondary endpoints were safety and tolerability of combinations, and correlation of pH with RAL PK.
Study Results
The multivitamin, Forceval, did not significantly affect the PK of RAL
Study Conclusions
Authors concluded that multivitamin use doesn't change PK of Raltegravir.
References
Reynolds, H, Lewis, J, Egan, D, Mas, C, Else, L, Chiong, J. The effect of antacids and multivitamins on raltegravir . Conference On Retroviruses And Opportunistic Infections. Boston. ; March 2018.
Raltegravir vs Maalox Plus
^
Study Design
Participants received a single dose (sd) of RAL (400 mg tablet), followed by RAL plus Maalox Plus (30 ml), Maalox Plus (30 ml) 2 h prior to dosing without food, for 4 study days. The Heidelberg pH diagnostic system was used to collect gastrointestinal pH data. Blood samples and pH measurements were collected at 0, 1, 2, 3, 4, 6, 8, 10 and 12 h post dose. Plasma RAL concentrations were determined by validated LC-MS/MS, and PK parameters were estimated (WinNonLin). The primary endpoint was a change in AUC, C12h, CMAX, or TMAX. Secondary endpoints were safety and tolerability of combinations, and correlation of pH with RAL PK.
Study Results
A significant decrease in TMAX (GMR 0.58; 90 % CI 0.43 – 0.78) was seen when Maalox Plus was administered at the same time as RAL which was not observed when the antacid was taken 2 h prior to RAL.
Study Conclusions
Author concluded that co-administration of Maalox Plus will cause a significant decrease in absorption of Raltegravir while administration of Maalox Plus 2h prior does not exhibit the same effect.
References
Reynolds, H, Lewis, J, Egan, D, Mas, C, Else, L, Chiong, J. The effect of antacids and multivitamins on raltegravir . Conference On Retroviruses And Opportunistic Infections. Boston. ; March 2018.
Raltegravir vs Sodium bicarbonate
^
Study Design
Open label, randomised, 5 phased controlled healthy volunteer study. Participants received a single dose (sd) of RAL (400 mg tablet), followed by sodium bicarbonate 1g 2 h prior to dosing without food, for 4 study days. The Heidelberg pH diagnostic system was used to collect gastrointestinal pH data. Blood samples and pH measurements were collected at 0, 1, 2, 3, 4, 6, 8, 10 and 12 h post dose. Plasma RAL concentrations were determined by validated LC-MS/MS, and PK parameters were estimated (WinNonLin). The primary endpoint was a change in AUC, C12h, CMAX, or TMAX. Secondary endpoints were safety and tolerability of combinations, and correlation of pH with RAL PK
Study Results
A significant increase in RAL GMR (90 % CI) AUC0-12 (1.96; 1.04 – 3.72) and CMAX (2.07; 1.00 – 4.30) when RAL was administered with sodium bicarbonate was observed.
Study Conclusions
Author concluded that administration of sodium bicarbonate will cause a significant increase in concentration of Raltegravir which is likely to relate to the unopposed ‘boosting’ effect of a raised pH upon absorption and the known pH-dependent solubility of RAL.
References
Reynolds, H, Lewis, J, Egan, D, Mas, C, Else, L, Chiong, J. The effect of antacids and multivitamins on raltegravir . Conference On Retroviruses And Opportunistic Infections. Boston. ; March 2018.
Raltegravir vs Maalox Plus
^
Study Design
Participants received a single dose (sd) of RAL (400 mg tablet), followed by RAL plus Maalox Plus (30 ml), Maalox Plus (30 ml) 2 h prior to dosing without food, for 4 study days. The Heidelberg pH diagnostic system was used to collect gastrointestinal pH data. Blood samples and pH measurements were collected at 0, 1, 2, 3, 4, 6, 8, 10 and 12 h post dose. Plasma RAL concentrations were determined by validated LC-MS/MS, and PK parameters were estimated (WinNonLin). The primary endpoint was a change in AUC, C12h, CMAX, or TMAX. Secondary endpoints were safety and tolerability of combinations, and correlation of pH with RAL PK.
Study Results
A significant decrease in TMAX (GMR 0.58; 90 % CI 0.43 – 0.78) was seen when Maalox Plus was administered at the same time as RAL which was not observed when the antacid was taken 2 h prior to RAL.
Study Conclusions
Author concluded that co-administration of Maalox Plus will cause a significant decrease in absorption of Raltegravir while administration of Maalox Plus 2h prior does not exhibit the same effect.
References
Reynolds, H, Lewis, J, Egan, D, Mas, C, Else, L, Chiong, J. The effect of antacids and multivitamins on raltegravir . Conference On Retroviruses And Opportunistic Infections. Boston. ; March 2018.
Raltegravir vs Maalox Plus
^
Study Design
Participants received a single dose (sd) of RAL (400 mg tablet), followed by RAL plus Maalox Plus (30 ml), Maalox Plus (30 ml) 2 h prior to dosing without food, for 4 study days. The Heidelberg pH diagnostic system was used to collect gastrointestinal pH data. Blood samples and pH measurements were collected at 0, 1, 2, 3, 4, 6, 8, 10 and 12 h post dose. Plasma RAL concentrations were determined by validated LC-MS/MS, and PK parameters were estimated (WinNonLin). The primary endpoint was a change in AUC, C12h, CMAX, or TMAX. Secondary endpoints were safety and tolerability of combinations, and correlation of pH with RAL PK.
Study Results
A significant decrease in TMAX (GMR 0.58; 90 % CI 0.43 – 0.78) was seen when Maalox Plus was administered at the same time as RAL which was not observed when the antacid was taken 2 h prior to RAL.
Study Conclusions
Author concluded that co-administration of Maalox Plus will cause a significant decrease in absorption of Raltegravir while administration of Maalox Plus 2h prior does not exhibit the same effect.
References
Reynolds, H, Lewis, J, Egan, D, Mas, C, Else, L, Chiong, J. The effect of antacids and multivitamins on raltegravir. Conference On Retroviruses And Opportunistic Infections. Boston. ; March 2018.
Raltegravir vs Forceval
^
Study Design
Participants received a single dose (sd) of RAL (400 mg tablet), followed Forceval (1tablet) 2 h prior to dosing without food, for 4 study days. The Heidelberg pH diagnostic system was used to collect gastrointestinal pH data. Blood samples and pH measurements were collected at 0, 1, 2, 3, 4, 6, 8, 10 and 12 h post dose. Plasma RAL concentrations were determined by validated LC-MS/MS, and PK parameters were estimated (WinNonLin). The primary endpoint was a change in AUC, C12h, CMAX, or TMAX. Secondary endpoints were safety and tolerability of combinations, and correlation of pH with RAL PK.
Study Results
The multivitamin, Forceval, did not significantly affect the PK of RAL
Study Conclusions
Authors concluded that multivitamin use doesn't change PK of Raltegravir.
References
Reynolds, H, Lewis, J, Egan, D, Mas, C, Else, L, Chiong, J. The effect of antacids and multivitamins on raltegravir . Conference On Retroviruses And Opportunistic Infections. Boston. ; March 2018.
Raltegravir vs Forceval
^
Study Design
Participants received a single dose (sd) of RAL (400 mg tablet), followed Forceval (1tablet) 2 h prior to dosing without food, for 4 study days. The Heidelberg pH diagnostic system was used to collect gastrointestinal pH data. Blood samples and pH measurements were collected at 0, 1, 2, 3, 4, 6, 8, 10 and 12 h post dose. Plasma RAL concentrations were determined by validated LC-MS/MS, and PK parameters were estimated (WinNonLin). The primary endpoint was a change in AUC, C12h, CMAX, or TMAX. Secondary endpoints were safety and tolerability of combinations, and correlation of pH with RAL PK.
Study Results
The multivitamin, Forceval, did not significantly affect the PK of RAL
Study Conclusions
Authors concluded that multivitamin use doesn't change PK of Raltegravir.
References
Reynolds, H, Lewis, J, Egan, D, Mas, C, Else, L, Chiong, J. The effect of antacids and multivitamins on raltegravir . Conference On Retroviruses And Opportunistic Infections. Boston. ; March 2018.
Raltegravir vs Maalox Plus
^
Study Design
Participants received a single dose (sd) of RAL (400 mg tablet), followed by RAL plus Maalox Plus (30 ml), Maalox Plus (30 ml) 2 h prior to dosing without food, for 4 study days. The Heidelberg pH diagnostic system was used to collect gastrointestinal pH data. Blood samples and pH measurements were collected at 0, 1, 2, 3, 4, 6, 8, 10 and 12 h post dose. Plasma RAL concentrations were determined by validated LC-MS/MS, and PK parameters were estimated (WinNonLin). The primary endpoint was a change in AUC, C12h, CMAX, or TMAX. Secondary endpoints were safety and tolerability of combinations, and correlation of pH with RAL PK.
Study Results
A significant decrease in TMAX (GMR 0.58; 90 % CI 0.43 – 0.78) was seen when Maalox Plus was administered at the same time as RAL which was not observed when the antacid was taken 2 h prior to RAL.
Study Conclusions
Author concluded that co-administration of Maalox Plus will cause a significant decrease in absorption of Raltegravir while administration of Maalox Plus 2h prior does not exhibit the same effect.
References
Reynolds, H, Lewis, J, Egan, D, Mas, C, Else, L, Chiong, J. The effect of antacids and multivitamins on raltegravir . Conference On Retroviruses And Opportunistic Infections. Boston. ; March 2018.
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