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'Booster' study

Clinical trial • No longer enrolling • 3 August 2010
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

This study is looking at the safety and effectiveness(Of a drug or treatment). The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. In the standard procedure, Phase II clinical trials gauge efficacy, and Phase III trials confirm it. of a new boosting agent or "pharmacoenhancer" called GS-9350 (or Cobicistat).

The drug is used to boost other medications in the blood to make them more effective. Currently, a small dose of ritonavir is often prescribed to perform this function.

All people in the trial will receive  a background regimen containing atazanavir + emtricitabine/tenofovir (Truvada) and either GS-9350 or ritonavir as the boosting agent.

 

Official title:Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9350-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults
What is this trial studying?New drug – cobicistat (GS-9350)
Start date:late 2010

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

How many participants will this trial enrol?700

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 48 weeks.
Links to further information:
Related trials:

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
  • Have never taken HIV treatments
  • Viral load at least 5000 copies/ml

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.

Results:

This Phase 3A large clinical trial designed to establish whether a drug is effective and safe enough for widespread use. Phase III studies include expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling. clinical trialA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. met its 48-week primary objective of non-inferiority to ritonavir. See link to company press release.

Disclaimer

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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This Clinical trial was first published on 3 August 2010 — more than two years ago.

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The content of this website is intended to support, not replace, the relationship between people living with HIV/AIDS and their medical advisers, and is not intended as a substitute for medical advice.

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