Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV-1 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Raltegravir

Raltegravir 400mg oral twice daily

Group Type ACTIVE_COMPARATOR

Efavirenz

Intervention Type DRUG

Efavirenz 600mg oral at bedtime

Efavirenz

Efavirenz 600mg oral at bedtime

Group Type ACTIVE_COMPARATOR

Raltegravir

Intervention Type DRUG

Raltegravir 400mg oral twice daily

Interventions

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Raltegravir

Raltegravir 400mg oral twice daily

Intervention Type DRUG

Efavirenz

Efavirenz 600mg oral at bedtime

Intervention Type DRUG

Other Intervention Names

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Isentress Stocrit

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No