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| ID | Type | Description | Link |
|---|---|---|---|
| TVGH-IRB-2013-07-030B | Other Identifier | TaipeiVGH |
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A pilot study to compare the efficacy and safety of raltegravir-based versus efavirenz-based combination therapy in treatment-naïve patients with HIV-1 infection.
A single-center, prospective, randomized, open label, parallel study to compare the efficacy and safety of raltegravir-based versus efavirenz-based plus optimal nucleoside reverse-transcriptase inhibitors(NRTIs) backbone combination therapy in treatment-naïve patients with HIV-1 infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Raltegravir | Active Comparator | Raltegravir 400mg oral twice daily |
|
| Efavirenz | Active Comparator | Efavirenz 600mg oral at bedtime |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raltegravir | Drug | Raltegravir 400mg oral twice daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Patients Who Can Achieve of Less Than 20 HIV RNA Copies Per ml at Week 48 of Both Arms. | Virological response to achieve HIV RNA copies <20 copies/mL at week 48 of both arms. | At week 48 of both arms |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Patients With Achievement of Less Than 400 HIV RNA Copies Per ml at Week 48 for Both Arms. | Virological response to achieve HIV RNA copies <400 copies/mL at week 48 of both arms. | At week 48 of both arms |
| The Change From Baseline in Cluster of Differentiation 4(CD4) Cell Counts at Week 48 for Both Arms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wing Wai Wong, MD | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Infectious Diseases, Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19647866 | Background | Lennox JL, DeJesus E, Lazzarin A, Pollard RB, Madruga JV, Berger DS, Zhao J, Xu X, Williams-Diaz A, Rodgers AJ, Barnard RJ, Miller MD, DiNubile MJ, Nguyen BY, Leavitt R, Sklar P; STARTMRK investigators. Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection: a multicentre, double-blind randomised controlled trial. Lancet. 2009 Sep 5;374(9692):796-806. doi: 10.1016/S0140-6736(09)60918-1. Epub 2009 Aug 3. | |
| 20085491 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Raltegravir | Raltegravir 400mg oral twice daily Efavirenz: Efavirenz 600mg oral at bedtime |
| FG001 | Efavirenz | Efavirenz 600mg oral at bedtime Raltegravir: Raltegravir 400mg oral twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Raltegravir | Raltegravir 400mg oral twice daily Efavirenz: Efavirenz 600mg oral at bedtime |
| BG001 | Efavirenz | Efavirenz 600mg oral at bedtime Raltegravir: Raltegravir 400mg oral twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | The Proportion of Patients Who Can Achieve of Less Than 20 HIV RNA Copies Per ml at Week 48 of Both Arms. | Virological response to achieve HIV RNA copies <20 copies/mL at week 48 of both arms. | Posted | Count of Participants | Participants | At week 48 of both arms |
|
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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 | Raltegravir | Raltegravir 400mg oral twice daily Efavirenz: Efavirenz 600mg oral at bedtime |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. WEN-WEI KU | Taipei Veterans General Hospital | +886228751997 | stephaneku@gmail.com |
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| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| C098320 | efavirenz |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Efavirenz | Drug | Efavirenz 600mg oral at bedtime |
|
|
The change from baseline in cluster of differentiation 4(CD4) cell counts at week 48 for both arms. |
| At week 48 of both arms. |
| The Proportion of Treatment Failure at Week 48 for Both Arms. | The proportion of treatment failure, defined as detectable HIV RNA copies copies/mL, at week 48 for both arms. | At week 48 of both arms |
| Background |
| Steigbigel RT, Cooper DA, Teppler H, Eron JJ, Gatell JM, Kumar PN, Rockstroh JK, Schechter M, Katlama C, Markowitz M, Yeni P, Loutfy MR, Lazzarin A, Lennox JL, Clotet B, Zhao J, Wan H, Rhodes RR, Strohmaier KM, Barnard RJ, Isaacs RD, Nguyen BY; BENCHMRK Study Teamsa. Long-term efficacy and safety of Raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant HIV infection: week 96 results of the BENCHMRK 1 and 2 Phase III trials. Clin Infect Dis. 2010 Feb 15;50(4):605-12. doi: 10.1086/650002. |
| 21126956 | Background | Young B, Vanig T, Dejesus E, Hawkins T, St Clair M, Yau L, Ha B, Shield Study Team. A pilot study of abacavir/lamivudine and raltegravir in antiretroviral-naive HIV-1-infected patients: 48-week results of the SHIELD trial. HIV Clin Trials. 2010 Sep-Oct;11(5):260-9. doi: 10.1310/hct1105-260. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Baseline VL >100,000 copies/mL | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | The Proportion of Patients With Achievement of Less Than 400 HIV RNA Copies Per ml at Week 48 for Both Arms. | Virological response to achieve HIV RNA copies <400 copies/mL at week 48 of both arms. | Posted | Count of Participants | Participants | At week 48 of both arms |
|
|
|
| Secondary | The Change From Baseline in Cluster of Differentiation 4(CD4) Cell Counts at Week 48 for Both Arms. | The change from baseline in cluster of differentiation 4(CD4) cell counts at week 48 for both arms. | Not Posted | At week 48 of both arms. | Participants |
| Secondary | The Proportion of Treatment Failure at Week 48 for Both Arms. | The proportion of treatment failure, defined as detectable HIV RNA copies copies/mL, at week 48 for both arms. | Posted | Count of Participants | Participants | At week 48 of both arms |
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| 4 |
| 51 |
| EG001 | Efavirenz | Efavirenz 600mg oral at bedtime Raltegravir: Raltegravir 400mg oral twice daily | 0 | 54 | 0 | 54 | 10 | 54 |
| CK Elevation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hypertriglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Swallowing Difficulties | Gastrointestinal disorders | Systematic Assessment |
|
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