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NCT Number: NCT01989910

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

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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Key information

Conditions

HIV-1 Infection

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Division of Infectious Diseases, Taipei Veterans General Hospital

Taipei, 11217, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

raltegravir

Drug

Raltegravir 400mg oral twice daily

Other names: Isentress

Efavirenz

Drug

Efavirenz 600mg oral at bedtime

Other names: Stocrit

Primary outcomes

  1. The Proportion of Patients Who Can Achieve of Less Than 20 HIV RNA Copies Per ml at Week 48 of Both Arms.

    Time frame: At week 48 of both arms

    Virological response to achieve HIV RNA copies <20 copies/mL at week 48 of both arms.

Secondary outcomes

  1. The Proportion of Patients With Achievement of Less Than 400 HIV RNA Copies Per ml at Week 48 for Both Arms.

    Time frame: At week 48 of both arms

    Virological response to achieve HIV RNA copies <400 copies/mL at week 48 of both arms.

  2. The Change From Baseline in Cluster of Differentiation 4(CD4) Cell Counts at Week 48 for Both Arms.

    Time frame: At week 48 of both arms.

    The change from baseline in cluster of differentiation 4(CD4) cell counts at week 48 for both arms.

  3. The Proportion of Treatment Failure at Week 48 for Both Arms.

    Time frame: At week 48 of both arms

    The proportion of treatment failure, defined as detectable HIV RNA copies copies/mL, at week 48 for both arms.

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2017
First posted
Nov 21, 2013
Registry last updated
Feb 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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