A phase II/III randomised, open-label study of combination antiretroviral regimens and treatment-switching strategies in HIV-1 infected antiretroviral naïve children >30 days and <18 years of age.

What is the best combination of anti-HIV drugs for children who are starting therapy for the first time? And when should they switch to different combinations?

What is this study about?

PENPACT 1 was a study for children with HIV infection who needed to start treatment for the first time. It had two main aims:

  1. To compare different combinations of anti-HIV drugs to see which is the best to start with in order to slow the growth of the HIV virus in the body, and to see which has the least side-effects for children.
  2. To decide what to do if the HIV level rises again in the blood. This trial looked at whether it is better to change to a new set of anti-HIV drugs as soon as the virus becomes detectable, or if it is better to wait until the amount of virus in the blood is higher.

Type of study

Randomised trial

Contact details

Who is funding the study?

In Europe the trial was funded by PENTA (EU funded) and a number of countries provided local support. In the UK the trial was funded by the Medical Research Council. Sites in the USA and South America were funded by the American NIAID and NICHD.

When is it taking place?

This trial closed to recruitment in September 2005. All children were monitored until September 2009.

Where is it taking place?

Children were enrolled from countries in Europe and North and South America.

Who is included?

Children with HIV infection who were at least 30 days old and less than 18 years of age who had not had previous treatment with anti-HIV drugs. A total of 266 children took part in this trial.