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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This is a pilot, open-label study of raltegravir and maraviroc in combination for the treatment of antiretroviral naïve patients. The study will enroll 7 antiretroviral naïve patients with CD4 counts ≥ 350 and viral loads > 5,000. The subjects will be followed for 48 weeks. The combination of these two agents has the potential to be a potent regimen with minimal metabolic complications. However, they have not been studied in combination previously.
This pilot study proposes to evaluate this combination in antiretroviral naïve patients to document the safety and efficacy of this combination in order to provide clinicians with a treatment regimen that minimizes the risk of metabolic complications.
Seven antiretroviral naïve HIV infected participants will be treated with a combination of raltegravir and maraviroc and followed for 48 weeks to determine the time to virologic suppression of (HIV-1 viral load < 50 copies/ml).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label ART | Experimental | Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raltegravir and Maraviroc in combination | Drug | Raltegravir 400 mg tablet twice a day, ~12 hours (10 to 14 hours) apart Maraviroc 300 mg tablet twice a day, ~12 hours (10 to 14 hours) apart |
| Measure | Description | Time Frame |
|---|---|---|
| Viral Load | Percentage of subjects with HIV-1 viral load < 50 copies/ml | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Viral Suppression | Time to attainment of virologic suppression | 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert R. Redfield, MD | University of Maryland, Institute of Human Virology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland, Institute of Human Virology | Baltimore | Maryland | 21201 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Label ART | Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks. Raltegravir and Maraviroc in combination: Raltegravir 400 mg tablet twice a day, ~12 hours (10 to 14 hours) apart Maraviroc 300 mg tablet twice a day, ~12 hours (10 to 14 hours) apart |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label ART | Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks. Raltegravir and Maraviroc in combination: Raltegravir 400 mg tablet twice a day, ~12 hours (10 to 14 hours) apart Maraviroc 300 mg tablet twice a day, ~12 hours (10 to 14 hours) apart |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Viral Load | Percentage of subjects with HIV-1 viral load < 50 copies/ml | Posted | Count of Participants | Participants | 48 weeks |
|
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48 weeks
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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 | Open Label ART | Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks. Raltegravir and Maraviroc in combination: Raltegravir 400 mg tablet twice a day, ~12 hours (10 to 14 hours) apart Maraviroc 300 mg tablet twice a day, ~12 hours (10 to 14 hours) apart |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Cardiac disorders | Systematic Assessment | Not study related, Adverse Event occurred before study drug started. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment | Fatigue resolved |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory Brogden | University of Maryland, Baltimore, IHV | 410-706-1660 | gbrogden@ihv.umaryland.edu |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| D000077592 | Maraviroc |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Single arm treatment study
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|
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Secondary | Viral Suppression | Time to attainment of virologic suppression | Posted | Number | weeks | 48 weeks |
|
|
|
|
| 0 |
| 7 |
| 2 |
| 7 |
| 6 |
| 7 |
|
| Gunshot Wound | Gastrointestinal disorders | Systematic Assessment | Not study related |
|
| Light headedness | General disorders | Systematic Assessment | Resolved |
|
| Mouth ulcers | General disorders | Systematic Assessment | Resolved |
|
| Dental Infection | Infections and infestations | Systematic Assessment | Treatment Resolved |
|
| Syncopal Episode | General disorders | Systematic Assessment | Dehydration, resolved |
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| Kidney Stones | Renal and urinary disorders | Systematic Assessment | Treatment resolved |
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| 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 |
| D012897 | Slow Virus Diseases |
| D003510 |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |