A randomised phase II trial to compare the toxicity, tolerability and activity of 2-drug combinations of the nucleoside analogue reverse transcriptase inhibitors (NRTIs) lamivudine ((-)2'-deoxy-3'thiacytidine, 3tc), zidovudine (ZDV) and 1592U89
ISRCTN | ISRCTN31541725 |
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DOI | https://doi.org/10.1186/ISRCTN31541725 |
Secondary identifying numbers | G9627716 |
- Submission date
- 03/10/2000
- Registration date
- 03/10/2000
- Last edited
- 07/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Diana Gibb
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Phone | +44 (0)20 7670 4709 |
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d.gibb@ctu.mrc.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | A randomised phase II trial to compare the toxicity, tolerability and activity of 2-drug combinations of the nucleoside analogue reverse transcriptase inhibitors (NRTIs) lamivudine ((-)2'-deoxy-3'thiacytidine, 3tc), zidovudine (ZDV) and 1592U89 |
Study acronym | PENTA 5 |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 23/01/1998 |
Completion date | 31/07/1999 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 120 |
Key inclusion criteria | 1. 3 months to 16 years of age 2. Definitive HIV-1 infection |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 23/01/1998 |
Date of final enrolment | 31/07/1999 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
Phone | +44 (0)20 7636 5422 |
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clinical.trial@headoffice.mrc.ac.uk | |
Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan | Not provided at time of registration |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Other publications | 15/04/2000 | Yes | No | ||
Other publications | 01/09/2001 | Yes | No | ||
Results article | 02/03/2002 | Yes | No | ||
Results article | 01/08/2002 | Yes | No | ||
Other publications | 27/09/2002 | Yes | No | ||
Other publications | Adherence to prescribed antiretroviral therapy | 01/01/2003 | Yes | No | |
Other publications | 5 year follow up | 11/05/2007 | Yes | No |
Editorial Notes
07/11/2022: Internal review.