Phase 1
Completed N=18
A Pharmacokinetic Study to Evaluate the Effect of MAALOX on Raltegravir (MK-0518) in Human Immunodeficiency Virus (HIV)-Infected Participants (MK-0518-295)
Source: ClinicalTrials.gov NCT01930045 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcomePrimary: Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 1 — 241.35; 96.29; 92.22 nM — p=0.507
Summary
This study evaluated the effect of single doses of a magnesium/aluminum antacid (MAALOX) given 4 and 6 hours before or after administration of raltegravir, on the pharmacokinetics of raltegravir in human immunodeficiency virus (HIV)-infected participants. The study consisted of Part 1 (Periods 1, 2, and 3) and Part 2 (Periods 4 and 5), with each study period separated by a washout period of at least 2 days; Part 1 was separated from Part 2 by a Pause. Each study period had a duration of ≥2 days, and paused for evaluation of Part 1 pharmacokinetics results before continuing to Part 2. The same participants participated in Parts 1 and 2. The primary hypothesis tested (in Part 1) was that raltegravir plasma concentration 12 hours after administration (C 12 hrs) would not differ significantly from raltegravir C 12 hrs when antacid is administered 4 hours before or 4 hours after raltegravir.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 1 |
241.35; 96.29; 92.22 | 0.507 |
| PRIMARY Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 1 |
17055.21; 13881.87; 11602.02 | — |
| PRIMARY Maximum Plasma Concentration (C Max) of Raltegravir in Part 1 |
4723.00; 3690.96; 3324.84 | — |
| PRIMARY Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 2 |
241.35; 121.52; 122.39 | — |
| PRIMARY Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 2 |
17055.21; 14799.48; 15104.15 | — |
| PRIMARY Maximum Plasma Concentration (C Max) of Raltegravir in Part 2 |
4723.00; 4268.72; 4256.01 | — |
Eligibility Criteria
Inclusion Criteria
- On a stable raltegravir dose as part of a stable antiretroviral regimen for ≥1 month before the study
- If female, is not pregnant or breast feeding
- Body mass index ≤32 kg/m^2
Exclusion Criteria
- Mentally or physically incapacitated, has significant emotional problems, or history of clinically significant psychiatric disorder within ≤10 years
- History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or disease (excluding HIV)
- History of gastric bypass surgery
- History of cancer, except adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies which have been successfully treated ≥10 years before the study
- History of chronic diarrhea within ≤3 months before the study
- History of significant multiple and/or severe allergies (food, drug, latex), or had an anaphylactic reaction or significant intolerability to drugs or food
- Had major surgery or donated or lost ≥1 unit of blood (500 mL) ≤4 weeks before the study
- Participated in another investigational trial ≤4 weeks before the study
- Taking rifampin or is unable to refrain from the use of 1) any proton pump inhibitor from 2 weeks before and throughout the study, or 2) any histamine H2-blockers, antacids, calcium supplements, or multivitamins from 2 weeks before and throughout the study
- Consumes >3 glasses of alcoholic beverages per day
- Consumes excessive amounts of caffeine beverages (coffee, tea, cola, energy drinks, or other caffeinated drinks) per day
- Currently uses or has a history of drug abuse within ≤6 months before the study
Data sourced from ClinicalTrials.gov (NCT01930045). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.