Trial Outcomes & Findings for The Effect of Antacids on the Pharmacokinetics (PK) of Raltegravir in Human Immunodeficiency Virus (HIV)-Infected Participants (MK-0518-824) (NCT NCT02473367)
NCT ID: NCT02473367
Last Updated: 2018-08-27
Results Overview
In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS Ultra Strength (US) 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid Maximum Strength (MS) taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected from pre-dose up to 24 hours post-dose, and analysis of variance (ANOVA) modeling was performed on natural log-transformed values to derive geometric least-squares means.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
Results posted on
2018-08-27
Participant Flow
Males or females, at least 18 years of age, with HIV infection were enrolled in this trial.
Starting five days prior to Period 1 participants were treated with 1200 mg raltegravir (MK-0518), once daily for five days.
Participant milestones
| Measure |
Four Period Fixed Sequence
All participants entered the first of four treatment periods. Period 1: 1200 mg raltegravir alone; followed by Period 2: 1200 mg raltegravir and TUMS Ultra Strength (US) 1000 taken orally concomitantly; followed by Period 3: 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid Maximum Strength (MS) taken orally; followed by Period 4: 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. There was a maximum 7-day wait between each period where participants were treated once daily with 1200 mg raltegravir.
|
|---|---|
|
Period 1
STARTED
|
20
|
|
Period 1
COMPLETED
|
20
|
|
Period 1
NOT COMPLETED
|
0
|
|
Wait 1
STARTED
|
20
|
|
Wait 1
COMPLETED
|
19
|
|
Wait 1
NOT COMPLETED
|
1
|
|
Period 2
STARTED
|
19
|
|
Period 2
COMPLETED
|
19
|
|
Period 2
NOT COMPLETED
|
0
|
|
Wait 2
STARTED
|
19
|
|
Wait 2
COMPLETED
|
19
|
|
Wait 2
NOT COMPLETED
|
0
|
|
Period 3
STARTED
|
19
|
|
Period 3
COMPLETED
|
19
|
|
Period 3
NOT COMPLETED
|
0
|
|
Wait 3
STARTED
|
19
|
|
Wait 3
COMPLETED
|
19
|
|
Wait 3
NOT COMPLETED
|
0
|
|
Period 4
STARTED
|
19
|
|
Period 4
COMPLETED
|
18
|
|
Period 4
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Four Period Fixed Sequence
All participants entered the first of four treatment periods. Period 1: 1200 mg raltegravir alone; followed by Period 2: 1200 mg raltegravir and TUMS Ultra Strength (US) 1000 taken orally concomitantly; followed by Period 3: 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid Maximum Strength (MS) taken orally; followed by Period 4: 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. There was a maximum 7-day wait between each period where participants were treated once daily with 1200 mg raltegravir.
|
|---|---|
|
Wait 1
Withdrawal by Subject
|
1
|
|
Period 4
Lost to Follow-up
|
1
|
Baseline Characteristics
The Effect of Antacids on the Pharmacokinetics (PK) of Raltegravir in Human Immunodeficiency Virus (HIV)-Infected Participants (MK-0518-824)
Baseline characteristics by cohort
| Measure |
All Enrolled Participants
n=20 Participants
All participants who enrolled in the study
|
|---|---|
|
Age, Continuous
|
49.8 Years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dosePopulation: Per-Protocol: Participants who complied with the protocol sufficiently to ensure that generated data would reflect the effects of treatment, according to the underlying scientific model.
In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS Ultra Strength (US) 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid Maximum Strength (MS) taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected from pre-dose up to 24 hours post-dose, and analysis of variance (ANOVA) modeling was performed on natural log-transformed values to derive geometric least-squares means.
Outcome measures
| Measure |
Period 1: Raltegravir Only
n=20 Participants
1200 mg raltegravir, once at the start of Period 1
|
Period 2: Raltegravir + TUMS Concomitantly
n=19 Participants
1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2
|
Period 3: Raltegravir + 12 Hrs Leader Antacid
n=19 Participants
1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS
|
Period 4: Raltegravir + 12 Hrs TUMS
n=19 Participants
1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hrs (AUC 0-24hr) of Raltegravir Following Once Daily Administration of Raltegravir
|
53.7 hr*µM
Interval 44.2 to 65.2
|
14.8 hr*µM
Interval 12.4 to 17.7
|
46.3 hr*µM
Interval 36.0 to 59.6
|
48.5 hr*µM
Interval 39.0 to 60.3
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dosePopulation: Per-Protocol: Participants who complied with the protocol sufficiently to ensure that generated data would reflect the effects of treatment, according to the underlying scientific model.
In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS US 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid MS taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected from pre-dose up to 24 hours post-dose, and ANOVA modeling was performed on natural log-transformed values to derive geometric least-squares means.
Outcome measures
| Measure |
Period 1: Raltegravir Only
n=20 Participants
1200 mg raltegravir, once at the start of Period 1
|
Period 2: Raltegravir + TUMS Concomitantly
n=19 Participants
1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2
|
Period 3: Raltegravir + 12 Hrs Leader Antacid
n=19 Participants
1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS
|
Period 4: Raltegravir + 12 Hrs TUMS
n=19 Participants
1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Raltegravir Following Once Daily Administration of Raltegravir
|
20000 nM
Interval 16500.0 to 24300.0
|
5240 nM
Interval 4230.0 to 6490.0
|
17300 nM
Interval 12800.0 to 23300.0
|
19500 nM
Interval 15900.0 to 24000.0
|
PRIMARY outcome
Timeframe: 24 hours post-dosePopulation: Per-Protocol: Participants who complied with the protocol sufficiently to ensure that generated data would reflect the effects of treatment, according to the underlying scientific model.
In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS US 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid MS taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected at 24 hours post-dose, and ANOVA modeling was performed on natural log-transformed values to derive geometric least-squares means.
Outcome measures
| Measure |
Period 1: Raltegravir Only
n=20 Participants
1200 mg raltegravir, once at the start of Period 1
|
Period 2: Raltegravir + TUMS Concomitantly
n=19 Participants
1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2
|
Period 3: Raltegravir + 12 Hrs Leader Antacid
n=19 Participants
1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS
|
Period 4: Raltegravir + 12 Hrs TUMS
n=19 Participants
1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000
|
|---|---|---|---|---|
|
Plasma Concentration at 24 Hrs Post-dose (C24hr) of Raltegravir Following Once Daily Administration of Raltegravir
|
75.6 nM
Interval 55.3 to 103.0
|
39.6 nM
Interval 29.9 to 52.5
|
32.0 nM
Interval 23.7 to 43.2
|
32.4 nM
Interval 24.6 to 42.6
|
Adverse Events
Period 1: Raltegravir Only
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Period 2: Raltegravir + TUMS Concomitantly
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Period 3: Raltegravir + 12 Hrs Leader Antacid
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Period 4: Raltegravir + 12 Hrs TUMS
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Period 1: Raltegravir Only
n=20 participants at risk
1200 mg raltegravir, once at the start of Period 1
|
Period 2: Raltegravir + TUMS Concomitantly
n=19 participants at risk
1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2
|
Period 3: Raltegravir + 12 Hrs Leader Antacid
n=19 participants at risk
1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS
|
Period 4: Raltegravir + 12 Hrs TUMS
n=19 participants at risk
1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000
|
|---|---|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/20 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
5.3%
1/19 • Number of events 1 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/20 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
5.3%
1/19 • Number of events 1 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
5.3%
1/19 • Number of events 1 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/20 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
5.3%
1/19 • Number of events 1 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
Other adverse events
| Measure |
Period 1: Raltegravir Only
n=20 participants at risk
1200 mg raltegravir, once at the start of Period 1
|
Period 2: Raltegravir + TUMS Concomitantly
n=19 participants at risk
1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2
|
Period 3: Raltegravir + 12 Hrs Leader Antacid
n=19 participants at risk
1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS
|
Period 4: Raltegravir + 12 Hrs TUMS
n=19 participants at risk
1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.0%
1/20 • Number of events 1 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Number of events 1 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Number of events 1 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
5.3%
1/19 • Number of events 1 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
10.5%
2/19 • Number of events 2 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/20 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
5.3%
1/19 • Number of events 1 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
5.3%
1/19 • Number of events 1 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/20 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
5.3%
1/19 • Number of events 1 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
|
Infections and infestations
Upper respiratory tract infection
|
15.0%
3/20 • Number of events 3 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
10.5%
2/19 • Number of events 2 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
5.3%
1/19 • Number of events 1 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
10.5%
2/19 • Number of events 2 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
5.3%
1/19 • Number of events 1 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/20 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
5.3%
1/19 • Number of events 1 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Number of events 1 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/20 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
5.3%
1/19 • Number of events 1 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
|
Nervous system disorders
Headache
|
15.0%
3/20 • Number of events 3 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
5.3%
1/19 • Number of events 1 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/20 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
5.3%
1/19 • Number of events 1 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
0.00%
0/19 • Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir
Participants who received at least one dose of raltegravir
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
- Publication restrictions are in place
Restriction type: OTHER