An open randomised trial to evaluate different therapeutic strategies of combination therapy for HIV-1 infection

Which drugs should we use to treat people who are diagnosed with HIV?

What was this study about?

Antiretroviral therapy (ART) has greatly reduced the number of people whop get ill and die from HIV. But doctors aren’t sure which combination of drugs they should give at which point, and what drugs it[‘s best to give at the beginning of treatment, before the patient builds up a resistance to anti-HIV drugs.

The INITIO trial aimed to address these uncertainties. People who took part in this trial were divided at random into three groups:

  • People in the first group were given three drugs called didanosine, stavudine and efavirenz
  • People in the second group were given drugs called didanosine, stavudine and nelfinavir
  • People in the third group were given didanosine, stavudine, efavirenz and nelfinavir

This was a complex trial, involving people from 17 countries, and funding from 4 drug companies.

What difference did this study make?

Starting antiretroviral therapy with a three-drug regimen which includes the drug efavirenz was better than starting with regimens including nelfinavir or efavirenz plus nelfinavir.

Type of study

Randomised trial

Contact details

Who funded the study?

This study was funded by the drug companies Bristol Myers Squibb, Merck, Roche and GlaxoSmithKline.

When did it take place?

This trial began recruiting people in 1999. It closed to recruitment in 2002. The results of the trial were published in 2006.

Who was included?

911 people took part in this trial.