Trial Outcomes & Findings for The Effect of Antacids and Multivitamins on Raltegravir (NCT NCT01784302)
NCT ID: NCT01784302
Last Updated: 2026-08-17
Results Overview
The primary endpoint will be a change in raltegravir AUC0-12 h, following dosing of antacid or multivitamin. Data collected at the following time points: pre dose, 1, 2, 3, 4, 6, 8 10 and 12 h post dose on Days 1, 6, 11, 16 and 21.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Day 1, 6, 11, 16 and 21, over dosing period of 0-12 h
Results posted on
2026-08-17
Participant Flow
Participant milestones
| Measure |
Arm1: Raltegravir Plus Maalox Plus
Subjects received on Day 1 Raltegravir 400 mg, Day 6 raltegravir 400 mg + Maalox Plus 30 mL, Day 11 raltegravir 400 mg + multivitamin 1 tablet, Day 16 raltegravir 400 mg + sodium bicarbonate 1 g, Day 21 raltegravir 400 mg + Maalox Plus 30 mL 2 h prior to raltegravir dose
|
Arm 2: Raltegravir Plus Multivitamin
Subject received on Day 1 Raltegravir 400 mg, Day 6 raltegravir 400 mg + multivitamin 1 tablet, Day 11 raltegravir 400 mg + Maalox Plus 30 mL, Day 16 raltegravir 400 mg + Maalox Plus 30 mL 2 h prior to raltegravir dose, Day 21 raltegravir 400 mg + sodium bicarbonate 1g
|
Arm 3: Raltegravir Plus Sodium Bicarbonate
Subjects received on Day 1 Raltegravir 400 mg, Day 6 raltegravir 400 mg + sodium bicarbonate 1 g, Day 11 raltegravir 400 mg + Maalox Plus 30 mL, Day 16 raltegravir 400 mg + Maalox Plus 30 mL 2 h prior to raltegravir dose, Day 21 raltegravir 400 mg + multivitamin 1 tablet
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
4
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Antacids and Multivitamins on Raltegravir
Baseline characteristics by cohort
| Measure |
Arm 1: Raltegravir Plus Maalox Plus
n=5 Participants
Subjects received on Day 1 Raltegravir 400 mg, Day 6 raltegravir 400 mg + Maalox Plus 30 mL, Day 11 raltegravir 400 mg + multivitamin 1 tablet, Day 16 raltegravir 400 mg + sodium bicarbonate 1 g, Day 21 raltegravir 400 mg + Maalox Plus 30 mL 2 h prior to raltegravir dose
|
Arm 2: Ratlegravir Plus Multivitamin
n=5 Participants
Subject received on Day 1 Raltegravir 400 mg, Day 6 raltegravir 400 mg + multivitamin 1 tablet, Day 11 raltegravir 400 mg + Maalox Plus 30 mL, Day 16 raltegravir 400 mg + Maalox Plus 30 mL 2 h prior to raltegravir dose, Day 21 raltegravir 400 mg + sodium bicarbonate 1g
|
Arm 3: Raltegravir Plus Sodium Bicarbonate
n=5 Participants
Subjects received on Day 1 Raltegravir 400 mg, Day 6 raltegravir 400 mg + sodium bicarbonate 1 g, Day 11 raltegravir 400 mg + Maalox Plus 30 mL, Day 16 raltegravir 400 mg + Maalox Plus 30 mL 2 h prior to raltegravir dose, Day 21 raltegravir 400 mg + multivitamin 1 tablet
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=51 Participants
|
5 Participants
n=51 Participants
|
5 Participants
n=102 Participants
|
15 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=18 Participants
|
|
Age, Continuous
|
34 years
n=51 Participants
|
28 years
n=51 Participants
|
34 years
n=102 Participants
|
32 years
n=18 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=51 Participants
|
2 Participants
n=51 Participants
|
4 Participants
n=102 Participants
|
11 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=51 Participants
|
3 Participants
n=51 Participants
|
1 Participants
n=102 Participants
|
4 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=51 Participants
|
5 Participants
n=51 Participants
|
5 Participants
n=102 Participants
|
15 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=18 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=51 Participants
|
5 participants
n=51 Participants
|
5 participants
n=102 Participants
|
15 participants
n=18 Participants
|
PRIMARY outcome
Timeframe: Day 1, 6, 11, 16 and 21, over dosing period of 0-12 hThe primary endpoint will be a change in raltegravir AUC0-12 h, following dosing of antacid or multivitamin. Data collected at the following time points: pre dose, 1, 2, 3, 4, 6, 8 10 and 12 h post dose on Days 1, 6, 11, 16 and 21.
Outcome measures
| Measure |
Raltegravir 400 mg
n=14 Participants
400 mg stat dose administered to Arms 1, 2 and 3
|
Raltegravir 400 mg + Multivitamin
n=10 Participants
Raltegravir 400 mg stat dose plus 1 multivitamin administered to Arms 1, 2 and 3
|
Raltegravir 400 mg + Sodium Bicarbonate 1 g
n=11 Participants
Raltegravir 400 mg stat dose and sodium bicaronate 1 g administered to Arms 1, 2 and 3
|
Raltegravir 400 mg + Maalox Plus (30 mL)
n=11 Participants
Raltegravir 400 mg stat dose plus 30 mL of Maalox Plus administered to Arms 1, 2 and 3
|
Raltegravir 400 mg + Maalox Plus (30mL) 2 h Prior
n=10 Participants
Raltegravir 400 mg stat dose plus 30 mL Maalox Plus 2 h prior to raltegravir dosing administered to Arms 1, 2 and 3
|
|---|---|---|---|---|---|
|
Change in Raltegravir Area Under the Curve (AUC)0-12h
|
5150 ng.h/mL
Geometric Coefficient of Variation 85
|
4037 ng.h/mL
Geometric Coefficient of Variation 94
|
9964 ng.h/mL
Geometric Coefficient of Variation 61
|
4518 ng.h/mL
Geometric Coefficient of Variation 83
|
3768 ng.h/mL
Geometric Coefficient of Variation 101
|
SECONDARY outcome
Timeframe: Day 1, 6, 11, 16 and 21, four hours post dosePopulation: pH was measured over the dosing period. These results are for time point 4 h post dose.
Correlation between gastric pH and raltegravir pharmacokinetics
Outcome measures
| Measure |
Raltegravir 400 mg
n=11 Participants
400 mg stat dose administered to Arms 1, 2 and 3
|
Raltegravir 400 mg + Multivitamin
n=8 Participants
Raltegravir 400 mg stat dose plus 1 multivitamin administered to Arms 1, 2 and 3
|
Raltegravir 400 mg + Sodium Bicarbonate 1 g
n=8 Participants
Raltegravir 400 mg stat dose and sodium bicaronate 1 g administered to Arms 1, 2 and 3
|
Raltegravir 400 mg + Maalox Plus (30 mL)
n=8 Participants
Raltegravir 400 mg stat dose plus 30 mL of Maalox Plus administered to Arms 1, 2 and 3
|
Raltegravir 400 mg + Maalox Plus (30mL) 2 h Prior
n=9 Participants
Raltegravir 400 mg stat dose plus 30 mL Maalox Plus 2 h prior to raltegravir dosing administered to Arms 1, 2 and 3
|
|---|---|---|---|---|---|
|
Measurement of Gastrointestinal pH
|
5.5 pH
Standard Error 0.41
|
5.6 pH
Standard Error 0.54
|
6.7 pH
Standard Error 0.33
|
6.9 pH
Standard Error 0.41
|
6.7 pH
Standard Error 0.24
|
SECONDARY outcome
Timeframe: Day 1 up to end of study Day 27Population: The adverse events were analysed across all arms and not per arm as they received the same intervention. All participants received the same interventions in a different order according to arm. Adverse events were recorded separately for each intervention.
Number of adverse events reported from all arms of study including serious adverse events
Outcome measures
| Measure |
Raltegravir 400 mg
n=14 Participants
400 mg stat dose administered to Arms 1, 2 and 3
|
Raltegravir 400 mg + Multivitamin
n=10 Participants
Raltegravir 400 mg stat dose plus 1 multivitamin administered to Arms 1, 2 and 3
|
Raltegravir 400 mg + Sodium Bicarbonate 1 g
n=11 Participants
Raltegravir 400 mg stat dose and sodium bicaronate 1 g administered to Arms 1, 2 and 3
|
Raltegravir 400 mg + Maalox Plus (30 mL)
n=11 Participants
Raltegravir 400 mg stat dose plus 30 mL of Maalox Plus administered to Arms 1, 2 and 3
|
Raltegravir 400 mg + Maalox Plus (30mL) 2 h Prior
n=10 Participants
Raltegravir 400 mg stat dose plus 30 mL Maalox Plus 2 h prior to raltegravir dosing administered to Arms 1, 2 and 3
|
|---|---|---|---|---|---|
|
Number of Adverse Events
|
17 adverse events
|
7 adverse events
|
4 adverse events
|
7 adverse events
|
6 adverse events
|
Adverse Events
Raltegravir Alone
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Raltegravir Plus Maalox Plus
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Raltegravir Plus Maalox Plus 2h Prior
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Raltegravir Plus Sodium Bicarbonate
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Ratlegravir Plus Multivitamin
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Raltegravir Alone
n=14 participants at risk
Adverse events from participants receiving Raltegravir 400 mg
|
Raltegravir Plus Maalox Plus
n=10 participants at risk
Adverse events from participants raltegravir 400 mg + 30 mL Maalox Plus, 400 mg raltegravir + 30 mL Maalox Plus dosed 2 h prior,
|
Raltegravir Plus Maalox Plus 2h Prior
n=11 participants at risk
Adverse events from participants receiving raltegravir 400 mg plus Maalox Plus 2 h prior
|
Raltegravir Plus Sodium Bicarbonate
n=11 participants at risk
Adverse events from participants receiving raltegravir 400 mg + sodium bicarbonate 1 g
|
Ratlegravir Plus Multivitamin
n=10 participants at risk
Adverse events from participants receiving raltegravir 400 mg + multivitamin 1 tablet
|
|---|---|---|---|---|---|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/14 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/10 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
9.1%
1/11 • Number of events 1 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/11 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/10 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
Other adverse events
| Measure |
Raltegravir Alone
n=14 participants at risk
Adverse events from participants receiving Raltegravir 400 mg
|
Raltegravir Plus Maalox Plus
n=10 participants at risk
Adverse events from participants raltegravir 400 mg + 30 mL Maalox Plus, 400 mg raltegravir + 30 mL Maalox Plus dosed 2 h prior,
|
Raltegravir Plus Maalox Plus 2h Prior
n=11 participants at risk
Adverse events from participants receiving raltegravir 400 mg plus Maalox Plus 2 h prior
|
Raltegravir Plus Sodium Bicarbonate
n=11 participants at risk
Adverse events from participants receiving raltegravir 400 mg + sodium bicarbonate 1 g
|
Ratlegravir Plus Multivitamin
n=10 participants at risk
Adverse events from participants receiving raltegravir 400 mg + multivitamin 1 tablet
|
|---|---|---|---|---|---|
|
Investigations
Creatinine kinase elevation
|
21.4%
3/14 • Number of events 3 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/10 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/11 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
18.2%
2/11 • Number of events 2 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
10.0%
1/10 • Number of events 1 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
|
Investigations
Decreased eGFR
|
0.00%
0/14 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
10.0%
1/10 • Number of events 1 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/11 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
9.1%
1/11 • Number of events 1 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/10 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
|
General disorders
Headache
|
7.1%
1/14 • Number of events 1 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/10 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/11 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
9.1%
1/11 • Number of events 1 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/10 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
|
Gastrointestinal disorders
Diahorrea
|
7.1%
1/14 • Number of events 1 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/10 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/11 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/11 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/10 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
|
General disorders
Nausea
|
0.00%
0/14 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/10 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/11 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/11 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
10.0%
1/10 • Number of events 1 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
|
General disorders
Sore throat
|
7.1%
1/14 • Number of events 1 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/10 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/11 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/11 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/10 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/14 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
10.0%
1/10 • Number of events 2 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/11 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/11 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/10 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
|
Cardiac disorders
Vasovagal episode
|
7.1%
1/14 • Number of events 1 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/10 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/11 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/11 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/10 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
|
General disorders
Viral illness
|
0.00%
0/14 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
10.0%
1/10 • Number of events 1 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
9.1%
1/11 • Number of events 1 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/11 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/10 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
|
Investigations
Non- clinically significant laboratory investigations
|
50.0%
7/14 • Number of events 10 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
20.0%
2/10 • Number of events 2 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
9.1%
1/11 • Number of events 2 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
18.2%
2/11 • Number of events 3 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
30.0%
3/10 • Number of events 4 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
10.0%
1/10 • Number of events 1 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/11 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/11 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
0.00%
0/10 • Day 1 up to end of study day 27
Adverse events are reported per intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place