Evaluation of the Safety and Efficacy of Once Daily Reformulated Raltegravir with TRUVADA

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This trial is no longer enrolling. This may mean the trial is fully enrolled, or that enrolment in the trial has been halted or suspended. You cannot enrol in this trial.

About this trial

To evaluate the safety and efficacy of reformulated raltegravir 1200 mg once daily in combination with TRUVADA™ versus raltegravir 400 mg twice daily in combination with TRUVADA™ in people with HIV who have not taken treatment before.

 

NAPWHA commentary

Raltegravir is a highly effective and well tolerated HIV treatment.  It is currently approved for the treatment of HIV at a dose of 400mg twice a day when taken in combination with other HIV treatments.  

Some people take Raltegravir once daily after they have become undetectable, as some people prefer to take their treatment once a day.  

This study will establish the safety and effectiveness of starting treatment with at a higher dose of Raltegravir 

Official title: A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Reformulated Raltegravir 1200 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Each in Combination With TRUVADA™, in Treatment-Naïve HIV-1 Infected Subjects
What is this trial studying? Treatment strategy
Start date: June 2014

This may be the proposed or expected start date for trials which have not yet started.

How many participants will this trial enrol? 750

The exact number of participants may be lower or slightly higher than this. Some trials also have specific quotas for participants from each state, city or clinic.

How long is this trial planned to go for? Participants in this trial will be asked to take the trial drug for 48 Weeks. Following the conclusion of the trial, participants will be followed up for a further 96 Weeks.
Related treatments raltegravir
Links to further information: clinicaltrials.gov Evaluation of the Safety and Efficacy of Reformulated Raltegravir (MK-0518) 1200mg Once Daily

Who can enrol in this trial?

You may be eligible to participate in this trial if you meet the following criteria:

  • At least 18 years old
  • HIV-positive
  • Have never taken HIV treatments

You not be be eligible to participate in this trial if you meet any of the following criteria:

  • Currently taking HIV treatments
  • Have taken HIV treatments in the past
  • Demonstrated resistance to multiple HIV drugs and/or drug classes
  • Have active hepatitis B or C
  • Pregnant, or considering becoming pregnant during the course of the trial

This is a summary of key inclusion and exclusion criteria for this trial. There may be other criteria which may exclude some people from participation in this trial. Some laboratory tests may also be required. Consult your doctor, or view the trial protocol or informed consent documentation to see the full range of exclusion and inclusion criteria.

If you are interested in enrolling in this trial

Before making the decision to participate in any clinical trial, NAPWHA recommends that you discuss the potential benefits and risks of participation with your treating doctor. Your doctor can also provide advice about your eligibility to participate in the trial.

While NAPWHA has taken every care to compile the information on this page and to keep it up-to-date, we cannot guarantee its correctness and completeness.

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  • Before making the decision to participate in any clinical research, read our guide to clinical trials.
  • Email NAPWHA if you have any questions or comments about this trial