Trial record 14 of 44 for:
" January 19, 2011":" February 18, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
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
This study has been completed.
Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01286740
First received: January 27, 2011
Last updated: April 19, 2013
Last verified: April 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
HIV-1 Infection |
Drug: FTC/RPV/TDF |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Formic acid
Emtricitabine
Tenofovir
Efavirenz
Tenofovir Disoproxil Fumarate
Rilpivirine
Complera
U.S. FDA Resources
Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 (FDA Snapshot Analysis) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 48.
| Enrollment: | 50 |
| Study Start Date: | January 2011 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: FTC/RPV/TDF
Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
|
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:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286740
Locations
| United States, California | |
| Living Hope Clinical Foundation | |
| Long Beach, California, United States, 90814 | |
| Anthony Mills MD, Inc. | |
| Los Angeles, California, United States, 90069 | |
| Peter J. Ruane MD Inc | |
| Los Angeles, California, United States, 90036 | |
| La Playa Medical Group and Clinical Research | |
| San Diego, California, United States, 92103 | |
| United States, District of Columbia | |
| Whitman Walker Clinic | |
| Washington, District of Columbia, United States, 20009 | |
| Capital Medical Associates, PC | |
| Washington, District of Columbia, United States, 20036 | |
| Dupont Circle Physicians Group, P.C. | |
| Washington, District of Columbia, United States, 20009 | |
| United States, Florida | |
| The Kinder Medical Group | |
| Miami, Florida, United States, 33133 | |
| Orlando Immunology Center | |
| Orlando, Florida, United States, 32803 | |
| United States, Georgia | |
| Atlanta ID Group | |
| Atlanta, Georgia, United States, 30309 | |
| Infectious Disease Specialists of Atlanta | |
| Decatur, Georgia, United States, 30033 | |
| United States, Illinois | |
| Northstar Medical Center | |
| Chicago, Illinois, United States, 60657 | |
| United States, Massachusetts | |
| Community Research Initiative of New England | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Michigan | |
| Be Well Medical Center, P.C. | |
| Berkley, Michigan, United States, 48072 | |
| United States, Missouri | |
| Southampton Healthcare, Inc. | |
| St. Louis, Missouri, United States, 63139 | |
| United States, Texas | |
| Southwest Infectious Disease Clinical Research, Inc. | |
| Addison, Texas, United States, 75001 | |
| Central Texas Clinical Research | |
| Austin, Texas, United States, 78705 | |
| United States, Washington | |
| Peter Shalit, M.D. | |
| Seattle, Washington, United States, 98104 | |
Sponsors and Collaborators
Gilead Sciences
Investigators
| Study Director: | David Pugatch, MD | Gilead Sciences |
More Information
No publications provided
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01286740 History of Changes |
| Other Study ID Numbers: | GS-US-264-0111 |
| Study First Received: | January 27, 2011 |
| Results First Received: | March 8, 2013 |
| Last Updated: | April 19, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Gilead Sciences:
|
HIV-1 HIV Treatment Experienced |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Tenofovir Tenofovir disoproxil Efavirenz |
Efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination Emtricitabine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 22, 2013