An open, randomised trial to evaluate the activity and tolerability of combinations of reverse transcriptase and protease inhibitors, including induction therapy, in individuals with HIV-1 infection and CD4 counts greater than 25 x 106/L

Does adding a 4th drug to the usual treatment of 3 drugs help people with HIV?

What was this study about?

People living in the UK who are diagnosed with HIV are usually treated with a combination of 3 drugs. This treatment is usually very successful, but for some people (between 2 and 4 in every 10 people), it works less well.

The FORTE trial aimed to find out whether adding a 4th drug for the first 32 weeks of treatment could help to reduce unwanted side effects in the long term, and help to stop people becoming resistant to anti-HIV drugs. This way of treating people is called an induction/maintenance approach.

What difference did this study make?

This trial found that adding a 4th drug, and therefore adopting an induction/maintenance approach, could keep the amount of HIV virus in the blood lower for longer, whilst not increasing unwanted side effects.

Type of study

Randomised trial

Contact details

Who funded the study?

This study was funded by the Medical Research Council, and supported by a number of drug companies – Roche, Bristol Myers Squibb, Boehringer Ingelheim, Chiron and Bayer Diagnostics.

Where did it take place?

14 hospitals across the UK.

Who was included?

122 people took part in this trial.