PENPACT 1: 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 is a study for children with HIV infection who need to start treatment for the first time. It has 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 will look 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.
Who is included?
Children with HIV infection who are at least 30 days old and less than 18 years of age who have not had previous treatment with anti-HIV drugs.
A total of 266 children are taking part in this trial.
When is it taking place?
This trial closed to recruitment in September 2005. All children will be monitored until September 2009.
Where is it taking place?
Children have been enrolled from countries in Europe and North and South America.
Who is funding the study?
In Europe the trial is funded by PENTA (EU funded) and a number of countries provide local support.
In the UK the trial is funded by the Medical Research Council.
Sites in the USA and South America are funded by the American NIAID and NICHD.
|Type of study:||Randomised trial|
|Study start date:||Sep-02|
|Study end date:||Sep-09|
|Registrations achieved:||263, as of |
|Randomisations achieved:||263, as of September 2007|
|Chief investigator:||Dr. G. Tudor-Williams|
|Inclusion criteria:||1.Children >30 days and <18 years of age. Children may be randomized up to the day before their 18th birthday. 2. A confirmed diagnosis of HIV infection according to the current definition of the PACTG Virology Core Laboratory Committee. The current PACTG definition (April 17, 2000) requires two separate peripheral blood specimens from different days, and each specimen must be positive. The two positive results may be obtained in any combination of the following: at any age: HIV culture, HIV-DNA PCR, or plasma HIV RNA value >10,000 copies/mL ; age >4 weeks: neutralizable HIV p24 antigen (regular or ICD). age >18 months: licensed ELISA with confirmatory Western Blot. 3. Female subjects who are sexually active and able to become pregnant must agree to use the approved birth control methods for the assigned drug regimen under PENPACT 1. 4. Parent/legally authorized representative and child, where appropriate, must be able to provide written informed consent, and assent. 5. Antiretroviral naïve (or have received less than 56consecutive days after birth of antiviral drugs used to prevent mother-to-infant transmission) infants, children, and adolescents.|
|Exclusion criteria:||1. Infant or maternal peripartum NVP exposure for prevention of mother-to-child HIV transmission. 2. Current Grade 3 or 4 clinical or laboratory toxicity as defined by age appropriate toxicity tables in Appendices IV and V (Grade 3 and 4 thrombocytopenia will be allowed only if it is of immunological origin). 3. Active opportunistic infection and/or serious bacterial infection at the time of study entry. (Children may be enrolled after the acute phase). 4. History of clinical pancreatitis, peripheral neuropathy, or other clinical, hematologic, hepatic, or renal contraindications to receiving the trial therapies (i.e. impossibility to identify both a 2 NRTI + PI regimen and a 2 NRTI + NNRTI regimen that the child can take). 5. Current treatment with any medication known to be contraindicated with any of the drugs to be prescribed for the patient’s initial therapy (one of the NNRTIs or the selected PI; refer to Appendix IX).6. Receipt of any cytotoxic therapy for malignancy. 7. Pregnancy or breastfeeding. |
|Intervention and control groups:||Antiretroviral therapy|
|Method of randomisation:||Stratification|
Back to the top of page