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| ID | Type | Description | Link |
|---|---|---|---|
| ISR-In-US-264-0123 | Other Identifier | Gilead Sciences |
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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The study will be an open-label, pilot study in virologically suppressed patients comparing the efficacy, safety and tolerability of two Antiretroviral regimen strategies:
Arm A: "Immediate switch" Rilpivirine/Emtricitabine/Tenofovir (single tablet formulation (STF))at randomization
Arm B: "Delayed switch" Continue Nevirapine/Lamivudine/other Nucleoside reverse transcriptase inhibitor (NRTI)through 24 weeks then switch to STF of Rilpivirine/emtrictabine/tenofovir and followed through 48 weeks.
The current study is designed to be the first study to compare a continued nevirapine-based regimen to a switch to the FDC of rilpivirine/emtricitabine/tenofovir. Rwanda is a model country for implementation of newer approaches to more innovative ART strategies with an excellent National HIV Treatment program in place but has limited experience with clinical trials and as with most African countries has no clinical experience with Rilpivirine in treating HIV infected adults. Done in collaboration with Rwanda Biomedical center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rilpivirine/Emtricitabine/Tenofovir | Active Comparator | "Immediate switch": RILPIVIRINE/ EMTRICITABINE /TENOFOVIR FDC QDAY at randomization. |
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| Nevirapine/Lamivudine/ plus other NNRTI | Active Comparator | "Delayed switch": Continue NEVIRAPINE 200MG BID + LAMIVUDINE 300MG + OTHER NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR (NRTI) through 24 weeks then switch to RILPIVIRINE 25MG/ EMTRICITABINE 200MG/TENOFOVIR 300MG FDC QDAY and then follow through 48 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rilpivirine/Emtricitabine/Tenofovir | Drug | Rilpivirine 25mg/Emtricitiabine 200mg/Tenofovir 300mg FDC qday |
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| Measure | Description | Time Frame |
|---|---|---|
| Explore Efficacy | To compare proportion of subjects successfully maintaining a plasma viral load <200 copies /mL at week 24 in subjects randomized to rilpivirine/emtricitabine/tenofovir vs. in those randomized to initially continue nevirapine-based ART in this pilot study. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HIV RNA levels | To compare between arms the probability of having an HIV RNA level <50 and <400 copies/mL at 24 weeks | 24 weeks |
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Inclusion Criteria:
HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. A second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test or a previous detectable HIV RNA level
HIV RNA level below the limit of quantification of the viral load assay in use in-country within the last 12 months
Screening HIV RNA level below the limit of quantification as defined by the local assay
At least twelve months of stable first-line antiretroviral therapy consisting of nevirapine and 2 nRTIs approved by the Rwandan HIV Treatment guidelines. (No prior changes in ART are allowed)
Enrolled in the Rwanda National ART Program with no in-country transfer within the program.
Negative TB symptom screen or eligible based on algorithm outlined in
Laboratory values obtained within 30 days prior to study entry:
Hemoglobin greater than 8.0 g/dL
Platelet count greater than 40,000/mm3
AST (SGOT), ALT (SGPT), and alkaline phosphatase less than 5 X ULN
Total bilirubin less than 2.5 x ULN
Calculated creatinine clearance greater than 60 mL/min as estimated by the Cockcroft-Gault equation:
"Women of reproductive potential" is defined as women who have not been post-menopausal for at least 24 consecutive months (i.e., who have had menses within the preceding 24 months) and have not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation).
Age greater than18 years.
Ability and willingness of subject to give informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Zolopa, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rwanda Military Hospital | Kinombe | Rwanda |
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| ID | Term |
|---|---|
| D000068696 | Rilpivirine |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D000068678 | Emtricitabine, Rilpivirine, Tenofovir Drug Combination |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| D006571 |
| Heterocyclic Compounds |
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |