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| PENPACT 1: A phase II/III randomised, open-label study of combination antiretroviral regimens and treatment-switching strategies in antiretroviral naive children >30 days and <18 years of age |
| ISRCTN | ISRCTN73318385 |
| ClinicalTrials.gov identifier | NCT00039741 |
| Public title | PENPACT 1: A phase II/III randomised, open-label study of combination antiretroviral regimens and treatment-switching strategies in antiretroviral naive children >30 days and <18 years of age |
| Scientific title | |
| Acronym | PENPACT 1/ PENTA 9 |
| Serial number at source | E164/66 |
| Study hypothesis | PENPACT 1 is designed to evaluate the long-term efficacy, as measured by human immunodeficiency virus (HIV)-1 RNA over four years, of different initial highly active antiretroviral therapy (HAART) combinations in children and different strategies for switching therapy. The trial is also known as PENTA 9 and PACTG 390. |
| Ethics approval | Added as of 24/09/2007: Full ethics approval granted by Eastern Multi-centre Research Ethics Committee on 22/03/2002. |
| Study design | Randomised controlled trial |
| Countries of recruitment | Argentina, Austria, Bahamas, Brazil, France, Germany, Irleand, Italy, Puerto Rico, Romania, Spain, United Kingdom, United States of America |
| Disease/condition/study domain | Paediatric HIV |
| Participants - inclusion criteria |
1. Children >30 days and <18 years of age
2. A confirmed diagnosis of HIV infection 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. In most cases, drug regimens mandate the use of two methods of birth control. In these instances, hormonal birth control alone would not be considered adequate or effective. A medically accepted barrier method of contraception (e.g. condom) must also be used during the study. The interaction between study drugs and hormonal birth control has not been studied. 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 56 consecutive days after birth of antiviral drugs used to prevent mother-to-infant transmission) infants, children, and adolescents |
| Participants - exclusion criteria |
1. Infant or maternal peripartum nevirapine (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 nucleoside reverse transcriptase inhibitor [NRTI] + protease inhibitor [PI] regimen and a 2 NRTI + non-nucleoside reverse transcriptase inhibitor [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) 6. Receipt of any cytotoxic therapy for malignancy 7. Pregnancy or breastfeeding |
| Anticipated start date | 01/09/2002 |
| Anticipated end date | 01/09/2009 |
| Status of trial | Ongoing |
| Patient information material | Patient information can be found in the full protocol at: http://www.pentatrials.org/pp1v3web.pdf |
| Target number of participants | 256 planned, 263 recruited as of Sept 2006 |
| Interventions |
Status of trial: Closed to recruitment. In follow-up.
Randomisation to: 1. Start therapy with a regimen containing a protease inhibitor (PI) or a non-nucleoside reverse transcriptase inhibitor (NNRTI) 2. Switch therapy when HIV viral load reaches 1000 or 30,000 copies/ml |
| Primary outcome measure(s) |
1. To compare the combination of two NRTIs plus a protease inhibitor (PI) versus two NRTIs plus a non-nucleoside reverse transcriptase inhibitor (NNRTI) as initial therapy, followed by second-line therapy if virologic failure occurs, in terms of their effects on a long-term virologic endpoint
2. To compare two different viral load criteria for switching from first-line to second-line therapy |
| Secondary outcome measure(s) |
1. To evaluate and compare the safety and tolerability of each drug combination (including first- and second-line therapies)
2. To compare the long-term clinical and immunologic outcomes (by the initial randomization) 3. To compare the proportions of children who have undergone one regimen switch or reached study end-point (by the initial randomization) 4. To compare time from randomization to virologic failure (RNA >400 copies/ml at or after week 24) of the first-line therapy analyzed by initial randomization to either protease inhibitor (PI) or NNRTI containing regimens 5. To compare time from randomization to virologic failure of the second line therapy (RNA >30,000 copies/ml) analyzed by the initial randomization 6. To compare the proportion of children with plasma HIV-1 RNA <400 copies/ml at 4 years (by the initial randomization) 7. To describe resistance patterns at 4 years (by the initial randomization) |
| Sources of funding | PENPACT 1 is a collaboration between PENTA (funded by the EU) and the PACTG (funded by the NIAID/NICHD). Funding is also received from the UK Medical Research Council. |
| Trial website | http://www.pentatrials.org/trials.htm#penpact1 |
| Publications |
1. PENTA guidelines for the use of antiretroviral therapy, 2004, on http://www.ncbi.nlm.nih.gov/pubmed/15239717
2. Gibb DM, Melvin A, Compagnucci A, McKinney R, Tudor-Williams G, Walker AS, Harper L, Hodge J, Powell C, Green H, Saidi Y, Ortiz AA, Toye M, Girard S, Mofenson L, Giaquinto C, Hughes M on behalf of the PENPACT 1 Trial. Choice of first-line ART regimen in PENPACT 1: a randomized trial of combination antiretroviral regimens and treatment switching strategies in antiretroviral naive children >30 days and <18 years of age. XV International AIDS Conference, 11-16 July 2004, Bangkok. Poster TuPeB4442 |
| Contact name | Prof Diana Gibb |
| Address |
MRC Clinical Trials Unit
222 Euston Road |
| City/town | London |
| Zip/Postcode | NW1 2DA |
| Country | United Kingdom |
| Tel | +44 (0)207 670 4709 |
| Fax | +44 (0)207 670 4818 |
| d.gibb@ctu.mrc.ac.uk | |
| Sponsor | PENTA Foundation (Italy) |
| Address |
Dipartimento di Pediatria
Universita di Padova Via Giustiniani 3 |
| City/town | Padova |
| Zip/Postcode | 35128 |
| Country | Italy |
| Tel | +39 (0)49 821 3563 |
| Fax | +39 (0)49 875 3865 |
| carlog@pediatria.unipd.it | |
| Sponsor website: | http://www.pentatrials.org.uk |
| Date applied | 19/07/2002 |
| Last edited | 12/09/2008 |
| Date ISRCTN assigned | 19/07/2002 |
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