Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients
Information source: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV-1 Infection
Intervention: Raltegravir (Drug); Efavirenz (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Taipei Veterans General Hospital, Taiwan Official(s) and/or principal investigator(s): Wing Wai Wong, MD, Principal Investigator, Affiliation: Taipei Veterans General Hospital, Taiwan
Overall contact: Wing Wai Wong, MD, Phone: +886-938590783, Email: wwwong@vghtpe.gov.tw
Summary
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.
Clinical Details
Official title: An Open Label, Randomized, Parallel Design Estimation Pilot Study to Compare the Efficacy and Safety of Raltegravir-based Versus Efavirenz-based Combination Therapy in Treatment-naïve Patients With HIV-1 Infection
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The proportion of patients who can achieve of less than 20 HIV RNA copies per ml at week 48 of both arms.
Secondary outcome: The proportion of patients with achievement of less than 400 HIV RNA copies per ml at week 48 for both arms.The change from baseline in cluster of differentiation 4(CD4) cell counts at week 48 for both arms. The proportion of treatment failure at week 48 for both arms.
Detailed description:
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.
Eligibility
Minimum age: 20 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients who are infected with HIV-1
- Patients have not yet received any treatment for HIV
- Patients with HIV viral RNA exceeds 5000 copies per ml
- Ages at least 20 years
Exclusion Criteria:
- Patients with acute or decompensated chronic hepatitis
- Patients with chronic hepatitis and serum aminotransferase concentrations are more
than five times the upper limit of the normal range
- Patients with renal insufficiency (need dialysis or have serum creatinine
concentrations of more than twice the upper limit of the normal range
- Patients with any medical disorder that the use of study medications is
contraindicated
- Pregnant or breastfeeding women
- Patients who are lack of expectation to maintain assigned study medication during
study period
- Patients who have received therapy with investigational drugs in the previous 3
months
Locations and Contacts
Wing Wai Wong, MD, Phone: +886-938590783, Email: wwwong@vghtpe.gov.tw
Division of Infectious Diseases, Taipei Veterans General Hospital, Taipei 11217, Taiwan; Recruiting Wing Wai Wong, MD, Phone: +886-938590783, Email: wwwong@vghtpe.gov.tw Wing Wai Wong, MD, Principal Investigator
Additional Information
Related publications: 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. Erratum in: Lancet. 2009 Sep 5;374(9692):786. Lancet. 2009 Dec 19-2010 Jan 1;374(9707):2054. 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. 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-naïve 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.
Starting date: September 2013
Last updated: November 14, 2013
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