An open randomised trial to evaluate the activity and tolerability of combinations of reverse transcriptase and protease inhibitors, including induction therapy, in individuals with Human Immunodeficiency Virus-1 (HIV-1) infection and CD4 cell counts greater than 25 x 10 to the power of 6 per litre
ISRCTN | ISRCTN58987964 |
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DOI | https://doi.org/10.1186/ISRCTN58987964 |
Secondary identifying numbers | G9719167 (extension, ProCom trial) |
- Submission date
- 03/10/2000
- Registration date
- 03/10/2000
- Last edited
- 29/09/2009
- 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
Dr Malcolm Hooker
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
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 | |
Study acronym | The FORTE trial |
Study objectives | To evaluate, in patients starting anti-HIV therapy, the activity over at least 48 weeks of two regimens in terms of effects on plasma HIV RNA, CD4 cell counts, viral resistance, progression of HIV disease and survival, and safety and tolerability. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | HIV, Acquired Immunodeficiency Syndrome (AIDS) |
Intervention | 1. Didanosine (ddI), Stavudine (d4T), Nevirapine (NVP) plus Nelfinavir (NFV) for at least 24 weeks, then ddI, d4T and NVP as maintenance therapy 2. Continuous ddI, d4T plus NVP Note: third arm with continuous ddI, d4T, NVP plus NFV deleted November 2000. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | 2 regimens |
Primary outcome measure | Virological failure defined as failure to achieve plasma HIV RNA less than 50 copies per millilitre during the first 24 weeks or, having achieved such a level of suppression, subsequent rebound of plasma HIV RNA above 400 copies per millilitre. |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/10/1999 |
Completion date | 01/07/2002 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Not Specified |
Target number of participants | 100 |
Key inclusion criteria | 1. Age 18 years or more with documented HIV-1 infection and requiring anti-retroviral therapy 2. CD4 count greater than 25 x 10 to the power of 6 per litre 3. Any stage of HIV disease including recent infection (except acute symptomatic primary infection) 4. Likely to survive at least 2 years and take the allocated therapy for at least 6 months 5. Able to give informed consent |
Key exclusion criteria | 1. Previous anti-retroviral treatment or immunotherapies 2. Peripheral nephropathy or a history of pancreatitis 3. Women who are pregnant, breastfeeding or not taking adequate contraception 4. Heterosexual men not willing to use barrier contraception 5. Receiving combination chemotherapy for cancer 6. Receiving parenteral therapy for an opportunistic infection 7. Unlikely to comply with the protocol 8. At screening with creatinine above upper limit of normal (ULN), ALT or AST above 2.5 times ULN, amylase above 1.5 times ULN (except if pancreatic amylase less than 1.5 times ULN), haemoglobin less than 10.5g/dl, neutrophils less than 1.0 or platelets less than 100 |
Date of first enrolment | 01/10/1999 |
Date of final enrolment | 01/07/2002 |
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 (MRC) (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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/10/2007 | Yes | No |