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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| St. Joseph's Hospital, Florida | OTHER |
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The purpose of this study is to determine whether raltegravir 400 mg b.i.d. in a boosted PI regimen is as efficacious and safe as the NRTI backbone in a boosted PI regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: Boosted PI+RAL | Experimental | Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen Subjects in this study are HIV-Infected Patients who are on a stable boosted PI regimen; in this group are assigned to switched from their NRTIs as a Backbone to Raltegravir |
|
| 2: Boosted PI+NRTIs | No Intervention | Group 2 Continue the same regimen without change |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Switch NRTIs as a Backbone to Raltegravir | Drug | This is a multicenter, pilot randomized, controlled study to evaluate the safety and efficacy of raltegravir in patients switched from a stable boosted PI-based regimen with a NRTI backbone to raltegravir instead of their current NRTIs. A stable boosted PI-based regimen is defined as having a documented HIV RNA <75 copies/mL for ≥ 3 months prior to study entry, while receiving a boosted PI-based with NRTI backbone. Additionally, patients must not have had HIV RNA ≥ 75 copies/mL during the three months prior to study entry. Approximately 25 patients will be enrolled in the raltegravir treatment arm (Group 1) and approximately 25 patients in the continuation of the current NRTI backbone regimen treatment arm (Group 2). Patients will be randomly assigned 1:1 to a treatment group. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Suppressed Viral Load(<75 Copies/ml)in Raltegravir 400 mg Bid vs. NRTI Backbone, Each in Combination of Boosted PI Regimen | Number of patients with virologic suppression< 75 copies/ ml at 24 wk,in raltegravir 400 mg bid vs. NRTI backbone, each in combination of boosted PI regimen. | at 24weeks for each patient |
| Measure | Description | Time Frame |
|---|---|---|
| Virologic Suppression of < 75 Copies/ml at 48 Weeks | at 48 weeks for each patient |
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Inclusion Criteria:
Patient is a male or female at least 18 years of age on the day of signing the informed consent.
Patient is HIV positive as determined by enzyme-linked immunosorbent assay (ELISA) or HIV PCR.
Patient has documented HIV RNA <75 copies/mL for at least 3 months prior to study entry while on a stable boosted PI based regimen without a change in antiretroviral therapy and with no documentation of HIV RNA > or = 75 copies/mL during this time.
Patient has no history of documented coronary artery disease that clinical investigator deems as clinically significant.
Patient has the following laboratory values within 35 days prior to the treatment phase of this study:
Patient has no clinical evidence of active pulmonary disease; at the investigators, discretion a chest x-ray could be obtained if felt necessary.
Patient who is of reproductive potential agrees to use an acceptable method of birth control throughout the study.
Patient agrees to remain off prohibited concomitant medications as outlined in Section 3.2.1 of the protocol.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hillsborough Health Department Specialty Care Center | Tampa | Florida | 33602 | United States |
Per the inclusion and exclusion criteria
Participants were recruited from the HIllsborough County Health Department, and Tampa Care Clinic, Tampa, Florida.
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| ID | Title | Description |
|---|---|---|
| FG000 | Switched | Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen |
| FG001 | Controlled | Group 2 Continue the same regimen without change |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1: Boosted PI+RAL | Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen |
| BG001 | 2: Boosted PI+NRTIs | Group 2 Continue the same regimen without change |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Number of Patients With Suppressed Viral Load(<75 Copies/ml)in Raltegravir 400 mg Bid vs. NRTI Backbone, Each in Combination of Boosted PI Regimen | Number of patients with virologic suppression< 75 copies/ ml at 24 wk,in raltegravir 400 mg bid vs. NRTI backbone, each in combination of boosted PI regimen. | Posted | Number | participants | at 24weeks for each patient |
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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 | Switched | Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Faconi syndrome | Renal and urinary disorders | Faconi's syndrome in a patient who is on TDF/FTC base regimen. The patient recovered, the regimen switched TDF/FTC was switched to TDF sparing regimen and the patient was wihtdrawn form the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erthema | Skin and subcutaneous tissue disorders | Grade 1, Not related, not anticipated |
This is a pilot study and has a small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charurut Somboonwit, MD | USF Health | 813 3078067 | csomboon@health.usf.edu |
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| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
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| Participants |
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| Secondary | Virologic Suppression of < 75 Copies/ml at 48 Weeks | Posted | Number | participants | at 48 weeks for each patient |
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| 0 |
| 21 |
| 18 |
| 21 |
| EG001 | Controlled | Group 2 Continue the same regimen without change | 1 | 25 | 18 | 25 |
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| Constipation | Gastrointestinal disorders | Grade 1, Not related, not anticipated |
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| Pruritus( local, not drug rash)) | Skin and subcutaneous tissue disorders | Grade 1, Not related, not anticipated |
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| fatigue | General disorders | Grade 1, Not related, not anticipated |
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| swelling | Skin and subcutaneous tissue disorders | Grade 2, Not related, not anticipated |
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| rash | Skin and subcutaneous tissue disorders | Grade 1, Not related, not anticipated |
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| Instability | Nervous system disorders | Grade 2, Not related, not anticipated |
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| loss appetitie | General disorders | Grade 1, Not related, not anticipated |
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| Headache | Nervous system disorders | Grade 1, Not related, and anticipated Two event in the RAL arm is grade 2. Not related, and anticipated |
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| Depression | Psychiatric disorders | Grade 1, Not related, not anticipated |
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| Insomnia | Psychiatric disorders | Grade 1, Not related, not anticipated |
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| dry mouth | General disorders | Grade 1, Not related, not anticipated |
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| wheezing | Respiratory, thoracic and mediastinal disorders | Grade 1, Not related, not anticipated |
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| Back pain | Musculoskeletal and connective tissue disorders | Grade 1, Not related, not anticipated |
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| Worsening seasonal allergy | Immune system disorders | Grade 1, Not related, not anticipated |
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| sore throat | Infections and infestations | Grade 1, Not related, not anticipated |
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| weight gain | General disorders | Grade 1, Not related, not anticipated |
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| vomiting | Gastrointestinal disorders | Grade 2, Not related, not anticipated |
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| Cough | Respiratory, thoracic and mediastinal disorders | Grade 1, Not related, not anticipated |
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| Urinary frequency | Renal and urinary disorders | Grade 1, Not related, not anticipated |
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| flatulence | Gastrointestinal disorders | Grade 1, Not related, not anticipated |
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| Increase appetite | General disorders | Grade 1, Not related, not anticipated |
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| Dizziness | General disorders | Grade 1, Not related, not anticipated |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Grade 1 and 2, Not related, not anticipated |
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| abdominal pain | Gastrointestinal disorders | Grade 2, Not related, not anticipated |
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| Bronchitis | Respiratory, thoracic and mediastinal disorders | Grade 1 |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Grade 2 |
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| Condyloma removal | Surgical and medical procedures | Grade 2-not related |
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| Squamous cell carcinoma insitu | Skin and subcutaneous tissue disorders | Grade 2-not related |
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| diarrhea | Gastrointestinal disorders | Grade 1 |
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| Abnormal liver function | Gastrointestinal disorders | Grade 3, recovered , no action taken |
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| Basal cell carcinoma | Skin and subcutaneous tissue disorders | Grade 1-no action taken |
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