Condition category
Infections and Infestations
Date applied
03/10/2000
Date assigned
03/10/2000
Last edited
14/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.pentatrials.org/trials.htm#penpact1

Contact information

Type

Scientific

Primary contact

Prof Diana Gibb

ORCID ID

Contact details

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
+44 (0)20 7670 4709
d.gibb@ctu.mrc.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G9627716

Study information

Scientific title

Acronym

PENTA 5

Study hypothesis

Primary:
1. To compare the toxicity, tolerability and activity of three different 2-drug NRTI combinations in children taking either NFV or NFV placebo in Part A, and in those taking NFV in Part B. Activity will be assessed by effect on viral load measured by plasma HIV-1 RNA
2. To assess the tolerability and toxicity of NFV and NFV placebo in children in Part A

Secondary:
1. To compare the activity of NFV and NFV placebo in children taking one of the three 2-drug combinations in Part A
2. To describe the effect on viral resistance, CD4 cell count and clinical progression separately for the three NRTI groups and the NFV and NFV placebo groups
3. To compare the plasma viral load as measured by HIV-1 RNA in the 1592-containing arms with that in the non-1592 arms in children taking NFV or NFV placebo

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Human Immunodeficiency Virus (HIV), Acquired Immunodeficiency Syndrome (AIDS)

Intervention

Three different 2-drug nucleoside analogue reverse transcriptase inhibitors (NRTI) combinations in children taking either nelfinavir (NFV) or nelfinavir (NFV) placebo

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 measures

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)

Overall trial start date

23/01/1998

Overall trial end date

31/07/1999

Reason abandoned

Eligibility

Participant inclusion criteria

1. 3 months to 16 years of age
2. Definitive HIV-1 infection

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

120

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

23/01/1998

Recruitment end date

31/07/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results:
1. http://www.ncbi.nlm.nih.gov/pubmed/11531953
2. http://www.ncbi.nlm.nih.gov/pubmed/10776748
3. http://www.ncbi.nlm.nih.gov/pubmed/12134227
4. http://www.ncbi.nlm.nih.gov/pubmed/12351958
5. http://www.ncbi.nlm.nih.gov/pubmed/12544410
6. http://www.ncbi.nlm.nih.gov/pubmed/17457088
7. http://www.ncbi.nlm.nih.gov/pubmed/11888583

Publication citations

  1. King DJ, Gotch FM, Larsson-Sciard EL, , T-cell re-population in HIV-infected children on highly active anti-retroviral therapy (HAART)., Clin. Exp. Immunol., 2001, 125, 3, 447-454.

  2. Gibb DM, Newberry A, Klein N, de Rossi A, Grosch-Woerner I, Babiker A, Immune repopulation after HAART in previously untreated HIV-1-infected children. Paediatric European Network for Treatment of AIDS (PENTA) Steering Committee., Lancet, 2000, 355, 9212, 1331-1332.

  3. De Rossi A, Walker AS, Klein N, De Forni D, King D, Gibb DM, Increased thymic output after initiation of antiretroviral therapy in human immunodeficiency virus type 1-infected children in the Paediatric European Network for Treatment of AIDS (PENTA) 5 Trial., J. Infect. Dis., 2002, 186, 3, 312-320, doi: 10.1086/341657.

  4. De Rossi A, Walker AS, De Forni D, Gibb DM, , Biphasic decay of cell-associated HIV-1 DNA in HIV-1-infected children on antiretroviral therapy., AIDS, 2002, 16, 14, 1961-1963.

  5. Gibb DM, Goodall RL, Giacomet V, McGee L, Compagnucci A, Lyall H, , Adherence to prescribed antiretroviral therapy in human immunodeficiency virus-infected children in the PENTA 5 trial., Pediatr. Infect. Dis. J., 2003, 22, 1, 56-62, doi: 10.1097/01.inf.0000047674.63657.cd.

  6. Green H, Gibb DM, Walker AS, Pillay D, Butler K, Candeias F, Castelli-Gattinara G, Compagnucci A, Della Negra M, de Rossi A, Feiterna-Sperling C, Giaquinto C, Harper L, Levy J, Saidi Y, Wintergerst U, , Lamivudine/abacavir maintains virological superiority over zidovudine/lamivudine and zidovudine/abacavir beyond 5 years in children., AIDS, 2007, 21, 8, 947-955, doi: 10.1097/QAD.0b013e3280e087e7.

  7. Comparison of dual nucleoside-analogue reverse-transcriptase inhibitor regimens with and without nelfinavir in children with HIV-1 who have not previously been treated: the PENTA 5 randomised trial., Lancet, 2002, 359, 9308, 733-740, doi: 10.1016/S0140-6736(02)07874-1.

Additional files

Editorial Notes