Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults.
This study is ongoing, but not recruiting participants.
Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01309243
First received: March 3, 2011
Last updated: May 2, 2012
Last verified: April 2012
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Purpose
The purpose of the study is to evaluate the safety and efficacy of a single tablet regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate compared with a single tablet regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV 1 Infected, Antiretroviral Treatment-Naïve Adults. The FTC/RPV/TDF single tablet regimen could offer an alternative treatment option to patients who wish to simplify or improve the tolerability of their treatment but want to avoid using efavirenz due to concerns about central nervous system side effects, rash, elevations in plasma lipids as well as to women of childbearing potential.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV-1 Infection |
Drug: emtricitabine/rilpivirine/tenofovir disoproxil fumarate Drug: efavirenz/emtricitabine/tenofovir disoproxil fumarate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 3B, Randomized, Open-label Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV 1 Infected, Antiretroviral Treatment-Naïve Adults |
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
Atripla
U.S. FDA Resources
Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- The primary efficacy endpoint is the proportion of subjects who achieve HIV 1 RNA < 50 copies/mL at week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The change from baseline in CD4 count in each treatment arm at week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
- The change from baseline in CD4 count in each treatment arm at week 96 [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 700 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: EFV/FTC/TDF single tablet regimen
Single tablet regimen of efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg
|
Drug: efavirenz/emtricitabine/tenofovir disoproxil fumarate
Efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg single tablet regimen administered orally on an empty stomach preferably at bedtime (QHS)
Other Name: Atripla®
|
|
Experimental: FTC/RPV/TDF single tablet regimen
Single tablet regimen of emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg
|
Drug: emtricitabine/rilpivirine/tenofovir disoproxil fumarate
Emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg single tablet regimen administered orally with a meal QD
|
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.
- Plasma HIV 1 RNA levels ≥ 2,500 copies/mL at screening.
- No prior use of any approved or experimental anti-HIV drug for any length of time with the exception of PrEP (pre-exposure prophylaxis).
- No use of Truvada or Viread for pre-exposure prophylaxis (PrEP) within 30 days of screening.
- Screening genotype report showing sensitivity to EFV, FTC, TDF, and lack of the RPV mutations.
- 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.
- Serum amylase ≤ 5 x ULN (subjects with serum amylase > 5 x ULN will remain eligible if serum lipase is ≤ 5 x ULN).
- Adequate renal function.
- Males and Females of childbearing potential must agree to utilize highly effective contraception methods (two separate forms of contraception, one of which must be an effective barrier method, or be non-heterosexually active, practice sexual abstinence or have a vasectomized partner) from screening throughout the duration of study period and for 12 weeks following the last dose of study drug.
- Adult (≥ 18 years) males or non-pregnant females.
- Life expectancy ≥ 1 year.
Exclusion Criteria:
- A new AIDS defining condition diagnosed within the 30 days prior to screening with the exception of CD4 count and percentage.
- Females who are breastfeeding.
- Positive serum pregnancy test (female of childbearing potential).
- Proven or suspected acute hepatitis in the 30 days prior to study entry.
- Subjects receiving drug treatment for Hepatitis C, or subjects who are anticipated to receive treatment for Hepatitis C during the course of the study.
- Subjects experiencing decompensated cirrhosis.
- Have an implanted defibrillator or pacemaker.
- Current alcohol or substance abuse.
- A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma.
- Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline.
- Receiving ongoing therapy or anticipated to need to initiate drugs or herbal/natural supplements during the study that are contraindicated or not recommended for use, including drugs not to be used with FTC, EFV, RPV, TDF, and Atripla®; or subjects with known allergies to the excipients of the FTC/RPV/TDF single tablet regimen and/or Atripla® tablets.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01309243
Show 149 Study Locations
Show 149 Study LocationsSponsors and Collaborators
Gilead Sciences
Investigators
| Study Chair: | Todd Fralich, M.D. | Gilead Sciences |
More Information
No publications provided
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01309243 History of Changes |
| Other Study ID Numbers: | GS-US-264-0110 |
| Study First Received: | March 3, 2011 |
| Last Updated: | May 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Gilead Sciences:
|
HIV HIV-1 Antiretroviral Treatment-Naïve |
Additional relevant MeSH terms:
|
HIV Infections Efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination Emtricitabine 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 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