Tenofovir Disoproxil Fumarate/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects
NCT ID: NCT00112047
Last Updated: 2010-10-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
517 participants
INTERVENTIONAL
2003-07-31
2009-06-30
Brief Summary
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Detailed Description
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Week 48 to Week 96:
The study was extended and continued to evaluate the efficacy and safety of the two regimens up to a total treatment duration of 96 weeks. The regimen of EFV+FTC+TDF continued to be dosed as the component drugs (EFV + FTC + TDF), once daily, without regard to meals. The regimen of CBV+EFV was dosed as 2 pills (CBV, twice daily in the morning without regard to meals) + EFV (once daily, without regard to meals).
Week 96 to Week 144:
A further study extension changed the 3-pill EFV+FTC+TDF regimen to a 2-pill regimen of EFV + Truvada (\[TVD\]: a fixed-dose combination pill containing FTC/TDF), once daily without regard to meals, and continued to evaluate the efficacy and safety of the two regimens for a further 48 weeks up to a total study treatment duration of 144 weeks. The regimen of CBV+EFV continued to be dosed as 2 pills (CBV, twice daily in the morning without regard to meals) + EFV (once daily, without regard to meals).
Week 144 to end of study (Week 240):
A final study extension provided all study participants from both treatment regimens the option to switch their respective treatments to the 1-pill regimen of for a further 96 weeks up to a total study duration of 240 weeks (5 years) to further assess the efficacy and safety of ART regimen simplification. At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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EFV+CBV
Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine 150 mg + zidovudine 300 mg) taken twice daily from the start of the study until Week 144. At Week 144 all participants who opted to roll over into the additional 96-week study extension received Atripla (\[ATR\]; the fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg/EFV 600 mg) taken once daily until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Efavirenz (EFV)
Tablet containing 600 mg EFV, taken once daily, for 96 weeks
Lamivudine/zidovudine
Fixed-dose combination tablet containing lamivudine 150 mg/zidovudine 300 mg, taken twice daily, for 240 weeks
EFV+FTC+TDF
Participants in this arm received 3 component drugs: efaviren (EFV; 600 mg) + emtricitabine (FTC; 200 mg) + tenofovir disoproxil fumarate (tenofovir DF \[TDF\]; 300 mg) as 3 separate pills once daily from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF \[200/300 mg\] once daily) replaced the 2 component drugs FTC + TDF; participants continued to receive EFV 600 mg once daily. At Week 144 all participants who opted to roll over into the further 96-week study extension received ATR. At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Emtricitabine (FTC)
Capsule containing 200 mg FTC, taken once daily, for 96 weeks
Tenofovir Disoproxil Fumarate (TDF)
Tablet containing 300 mg TDF, taken once daily, for 96 weeks
Efavirenz (EFV)
Tablet containing 600 mg EFV, taken once daily, for 96 weeks
FTC/TDF
Fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg, once daily, from Week 96 to 144
FTC/TDF/EFV
Fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg/EFV 600 mg, taken once daily, from Week 144 to 240
Interventions
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Emtricitabine (FTC)
Capsule containing 200 mg FTC, taken once daily, for 96 weeks
Tenofovir Disoproxil Fumarate (TDF)
Tablet containing 300 mg TDF, taken once daily, for 96 weeks
Efavirenz (EFV)
Tablet containing 600 mg EFV, taken once daily, for 96 weeks
FTC/TDF
Fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg, once daily, from Week 96 to 144
FTC/TDF/EFV
Fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg/EFV 600 mg, taken once daily, from Week 144 to 240
Lamivudine/zidovudine
Fixed-dose combination tablet containing lamivudine 150 mg/zidovudine 300 mg, taken twice daily, for 240 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adequate renal function: Calculated creatinine clearance greater than or equal to 50 mL/min according to the Cockcroft-Gault Formula.
* Hepatic transaminases (aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\]) 3 x upper limit of normal (ULN).
* Total bilirubin less than or equal to 1.5 mg/dL.
* Adequate hematologic function (absolute neutrophil count greater than or equal to 1,000/mm\^3; platelets greater than or equal to 50,000/mm\^3; hemoglobin greater than or equal to 8.0 g/dL).
* Serum amylase less than or equal to 1.5 x ULN.
* Serum phosphorus greater than or equal to 2.2 mg/dL.
* Willingness to use effective contraception by both males and females while on study treatment and for 30 days following study drug completion.
* Life expectancy greater than or equal to 1 year
* The ability to understand and sign written informed consent form obtained prior to initiation of study procedures.
Exclusion Criteria
* A new AIDS-defining condition diagnosed (exception CD4 criteria) within 30 days of baseline.
* Receiving ongoing therapy with any of the following: nephrotoxic agents, probenecid, systemic chemotherapeutic agents, systemic corticosteroids, interleukin-2, drugs that interact with efavirenz. Administration of any of the above medications must be discontinued at least 30 days prior to baseline visit and for duration of study.
* Pregnant or lactating participants.
* Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma. Participants with biopsy-confirmed KS were eligible but must not have received any systemic therapy for KS within 30 days of baseline and not anticipated starting systemic therapy during the study.
* Prior history of renal or bone disease.
* Any other clinical condition prior to therapy that would make the participant unsuitable for the study or unable to comply with the dosing requirements in the opinion of the investigator.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Gilead Sciences, Inc
Principal Investigators
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Andrew Cheng, MD, PhD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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AIDS Healthcare Foundation Research
Beverly Hills, California, United States
Capital Medical Associates, P.C.
Washington D.C., District of Columbia, United States
Orlando Immunology Center
Orlando, Florida, United States
NorthStar Medical Center
Chicago, Illinois, United States
Jemsek Clinic
Huntersville, North Carolina, United States
Countries
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References
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Gallant JE, DeJesus E, Arribas JR, Pozniak AL, Gazzard B, Campo RE, Lu B, McColl D, Chuck S, Enejosa J, Toole JJ, Cheng AK; Study 934 Group. Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV. N Engl J Med. 2006 Jan 19;354(3):251-60. doi: 10.1056/NEJMoa051871.
Related Links
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Gilead Website
Viread website
Sustiva website
Other Identifiers
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GS-01-934
Identifier Type: -
Identifier Source: org_study_id