Study to Evaluate Switching From a Regimen Consisting of the Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (STR) to the Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate STR
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| ClinicalTrials.gov Identifier: NCT01286740 |
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Recruitment Status :
Completed
First Posted : January 31, 2011
Results First Posted : April 19, 2013
Last Update Posted : April 26, 2013
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Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
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Brief Summary:
The purpose of this Phase 2b study was to evaluate the efficacy and safety of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) STR, after switching from the efavirenz (EFV)/FTC/TDF STR at baseline, in maintaining HIV-1 RNA < 50 copies/mL at Week 12. HIV-infected patients were enrolled if they had received EFV/FTC/TDF for ≥ 3 months prior to study start, were experiencing safety or tolerability concerns (in particular, EFV-related intolerance), and wished to change to an alternate, better-tolerated regimen.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV-1 Infection | Drug: FTC/RPV/TDF | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 50 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2B Open Label Pilot Study to Evaluate Switching From a Regimen Consisting of a Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Single Tablet Regimen (STR) to Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) STR in Virologically Suppressed, HIV 1 Infected Subjects |
| Study Start Date : | January 2011 |
| Actual Primary Completion Date : | July 2011 |
| Actual Study Completion Date : | March 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
HIV/AIDS
| Arm | Intervention/treatment |
|---|---|
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Experimental: FTC/RPV/TDF
Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
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Drug: FTC/RPV/TDF
Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg single-tablet regimen (STR) administered orally with a meal once daily
Other Names:
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Primary Outcome Measures :
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 (FDA Snapshot Analysis) [ Time Frame: Week 12 ]The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 12 was analyzed using the FDA snapshot analysis.
Secondary Outcome Measures :
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis) [ Time Frame: Week 24 ]The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the FDA snapshot analysis.
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis) [ Time Frame: Week 48 ]The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA snapshot analysis.
- Plasma Concentration of RPV and EFV at Week 1 [ Time Frame: Week 1 ]The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 1.
- Plasma Concentration of RPV and EFV at Week 2 [ Time Frame: Week 2 ]The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 2.
- Plasma Concentration of RPV and EFV at Week 4 [ Time Frame: Week 4 ]The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 4.
- Plasma Concentration of RPV and EFV at Week 6 [ Time Frame: Week 6 ]The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 6.
- Plasma Concentration of RPV and EFV at Week 8 [ Time Frame: Week 8 ]The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 8.
- Plasma Concentration of RPV at Week 12 [ Time Frame: Week 12 ]The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 12.
- Plasma Concentration of EFV at Week 12 [ Time Frame: Week 12 ]The mean (SD) plasma concentration (ng/mL) of EFV was measured at Week 12. No analyses of EFV plasma concentrations were conducted after Week 12
- Plasma Concentration of RPV at Week 24 [ Time Frame: Week 24 ]The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 24.
- Plasma Concentration of RPV at Week 36 [ Time Frame: Week 36 ]The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 36.
- Plasma Concentration of RPV at Week 48 [ Time Frame: Week 48 ]The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 48.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Ability to understand and sign a written informed consent form
- Receiving EFV/FTC/TDF continuously for ≥ 3 months preceding the screening visit
- Plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels for ≥ 8 weeks prior to the screening visit and HIV-1 RNA < 50 copies/mL at the screening visit
- On their first antiretroviral drug regimen, and no HIV-1 RNA > 50 copies/mL measured at two consecutive time points after first achieving HIV RNA < 50 copies/mL
- Had a genotype prior to starting FTC/RPV/TDF and no known resistance to any of the study agents
- Normal ECG
- Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm^3; platelets ≥ 50,000/mm^3; hemoglobin ≥ 8.5 g/dL)
- Serum amylase ≤ 5 x ULN (subjects with serum amylase > 5 x ULN eligible if serum lipase ≤ 5 x ULN)
- Adequate renal function (estimated glomerular filtration rate ≥ 50 mL/min according to the Cockcroft-Gault formula)
- Males and Females of childbearing potential must have agreed to utilize highly effective contraception methods (two separate forms of contraception, one of which must be an effective barrier method, or be nonheterosexually active, practice sexual abstinence, or have a vasectomized partner) from screening throughout the duration of the study period and for 60 days following the last dose of study drug.
- Age ≥ 18 years
- Life expectancy ≥ 1 year
Exclusion Criteria:
- A new AIDS-defining condition diagnosed within 21 days prior to screening
- Females who were breastfeeding
- Positive serum pregnancy test (female of childbearing potential)
- Proven or suspected acute hepatitis in the 21 days prior to study entry
- Subjects receiving drug treatment for Hepatitis C, or subjects anticipated to receive treatment for Hepatitis C during the course of the study, or with a history of liver disease
- Was experiencing decompensated cirrhosis
- Implanted defibrillator or pacemaker
- Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance
- History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
- Active, serious infections requiring parenteral antibiotic or antifungal therapy within 21 days prior to Baseline
- All investigational drugs
- Ongoing therapy or anticipated need to initiate drugs or herbal/natural supplements during the study that were contraindicated or not recommended for use as indicated in the protocol, including drugs not to be used with FTC, RPV, and TDF; or subjects with known allergies to the excipients of the FTC/RPV/TDF STR
- Participation in any other clinical trial without prior approval from the sponsor was prohibited while participating in this trial
- Treatment with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
- Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01286740
Locations
Show 18 study locations
Sponsors and Collaborators
Gilead Sciences
Investigators
| Study Director: | David Pugatch, MD | Gilead Sciences |
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01286740 |
| Other Study ID Numbers: |
GS-US-264-0111 |
| First Posted: | January 31, 2011 Key Record Dates |
| Results First Posted: | April 19, 2013 |
| Last Update Posted: | April 26, 2013 |
| Last Verified: | April 2013 |
Keywords provided by Gilead Sciences:
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HIV-1 HIV Treatment Experienced |
Additional relevant MeSH terms:
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Emtricitabine, Rilpivirine, Tenofovir Drug Combination Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents |