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| ID | Type | Description | Link |
|---|---|---|---|
| MK0518-054 | |||
| 2009_681 |
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An open-label, 3-period, fixed-sequence study in a panel of 18 HIV-infected patients on MK0518 as part of a stable treatment regimen for HIV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 | Experimental | MK0518 |
|
| Period 2 | Experimental | famotidine + MK0518 |
|
| Period 3 | Experimental | omeprazole + MK0518 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK0518 (Raltegravir) | Drug | 400 mg oral tablet of MK0518 once every 12 hours. Period 1 duration is one day, Period 2 duration is one day, Period 3 duration is five days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir | Area Under the Plasma Concentration-Time Curve and peak concentration | 12 hours postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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A total of 18 participants were enrolled in the study.
Participants were recruited through Abbott Northwestern Hospital Infectious Diseases Clinic, Minneapolis, MN and Prism Research, St. Paul, MN, between June 2008 and March 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Raltegravir/Famotidine/Omeprazole | Period 1 - 400 mg Raltegravir x 1 day Period 2 - 20 mg Famotidine + 400 mg Raltegravir x 1 day Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Raltegravir |
|
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| famotidine | Drug | Single 20 mg famotidine oral tablet taken 2 hours prior to administration of AM dose of MK0518 |
|
| omeprazole | Drug | 20 mg oral tablet of omeprazole, once daily for 5 days |
|
| COMPLETED |
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| NOT COMPLETED |
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| Famotidine + Raltegravir |
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| Omeprazole + Raltegravir |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Raltegravir/Famotidine/Omeprazole | Period 1 - 400 mg Raltegravir x 1 day Period 2 - 20 mg Famotidine + 400 mg Raltegravir x 1 day Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Height | Mean | Full Range | Centimeters |
| |||||||||||||||||
| Weight | Mean | Full Range | Kilograms |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir | Area Under the Plasma Concentration-Time Curve and peak concentration | Eighteen HIV-Infected Patients | Posted | Geometric Mean | 95% Confidence Interval | µM*hr | 12 hours postdose |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prestudy | 1 | 18 | 0 | 18 | |||
| EG001 | 400 mg Raltegravir | Period 1 - 400 mg Raltegravir | 0 | 18 | 2 | 18 | ||
| EG002 | 20 mg Famotidine + 400 mg Raltegravir | Period 2 - 20 mg Famotidine + 400 mg Raltegravir | 0 | 18 | 1 | 18 | ||
| EG003 | 20 mg Omeprazole + 400 mg Raltegravir | Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5days | 0 | 18 | 6 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ruptured coronary artery plaque | Cardiac disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal feces | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| vomiting | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRA 12.1 | Non-systematic Assessment |
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| Knee pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| D015738 | Famotidine |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Geometric Mean Ratio |
| 1.45 |
| 95 |
| 1.09 |
| 1.93 |
| Non-Inferiority or Equivalence |
The raltegravir AUC0-12 hr geometric mean ratio (raltegravir + omeprazole/raltegravir) is noniferior at less than 2.0. |