AVX-754

This trial is concluded. This means the trial has been completed. When the results of the trial have been made public, they will be summarised in the 'outcomes' section of this page. You cannot enrol in this trial.

About this trial

The study will measure how safe and effective AVX-754 (a new Nucleoside Reverse Transcriptase Inhibitor [NRTIA type of anti-HIV drug that works by inhibiting a stage of the HIV life cycle called reverse transcription. Non-nucleosides work in a similar way, but are chemically different.]) is in treating people who have failed treatment with lamivudine (3TC).

Background information

People who have developed a resistance to (or 'failed' on) lamivudine (3TC) will show the M184V mutation.

Official title:

A Phase II, Randomised, Double-blind, Dose-ranging Study of AVX754 Versus Lamivudine in Treatment-experienced HIV-1 Infected Patients With the M184V Mutation in Reverse Transcriptase

What is this trial studying?

new_drug – NRTIs

Start date:

July 2005 (This may be the proposed or expected start date for trials which have not yet started.)

How many participants will this trial enrol?

52 (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 3 weeks. Following the conclusion of the trial, participants will be followed up for a further 24 weeks.

Links to further information:

• http://clinicaltrials.gov/ct2/show/NCT00126880?term=HIV&cond=HIV&cntry1=PA%3AAU&rank=21

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
• Viral load at least 2000 copies/ml
• Participants must have the M184V mutation

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

• You must not have hepatitis B (HBV)
• You must not have hepatitis C (HCV)
• Pregnant, or considering becoming pregnant during the course of the trial
• must not be currently taking lamivudine (3TC)

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.

Disclaimer

While NAPWA 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.

Before making the decision to participate in any clinical research, visit the NAPWA website for background information on participating in clinical research.

Contact NAPWA if you have any questions or comments about this trial.