Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NA
Study information
Scientific title
Acronym
INITIO
Study hypothesis
To compare in patients starting therapy for HIV infection, the activity of three strategies for using anti-retroviral regimens for at least 3 years in terms of the effects on CD4 cell counts, plasma HIV RNA, viral resistance, progression of HIV disease and survival.
Ethics approval
Protocol approved in Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, Portugal, Spain, Sweden, Switzerland, UK, Australia, New Zealand, Canada and Brazil.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
HIV-1 infection
Intervention
Randomisation of approximately 1000 participants, from 17 countries worldwide, to one of three drug regimens:
1. 2 NRTIs plus a NNRTI
2. 2 NRTIs plus a PI
3. 2 NRTIs plus a NNRTI and PI
Quality of life substudy:
Quality of life questionnaires to be completed by participants consenting to this substudy in participating countries.
Virology substudy:
Participants joining this substudy at participating sites will have plasma and cells taken for storage for further study.
Immunology substudy:
Participants joining this substudy from specified clinics, within 6-hour delivery time of the centralised immunology labs in five countries, UK, France, Australia, Switzerland and Italy, will have additional blood samples taken for detailed lymphocyte phenotypes, lymphoproliferative assays and CD8 T-cell specific activity. In addition, a tetanus toxoid vaccination will be given at week 24 for research purposes.
Lipodystrophy substudy:
Participants for this substudy will be recruited from Australia and at baseline, every 12 weeks and at first therapeutic failure, a patient assessment of body changes, fasting insulin, C-Peptide, fibrogen and plasminogen activator inhibitor and exercise level assessment will be taken. At baseline, every 24 weeks and at therapeutic failure a record will be made of: DEXA scan, single cut abdominal computed tomography (CT) scan, standardised anthropometry and an electrocardiogram (ECG).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Change in CD4 cell count between 2 and 3 years
2. The proportion of patients with plasma HIV RNA below 50 copies/ml at 3 years
Secondary outcome measures
1. Change in CD4 cell count between 2 and 3 years
2. Change in plasma HIV RNA at 3 years
3. The time on first regimen
4. Time on second regimen (where applicable)
5. The time to first plasma HIV RNA below 50 copies/ml
6. Phenotypic and genotypic drug resistance at 3 years
7. Progression of HIV disease (including death)
Overall trial start date
01/03/1999
Overall trial end date
31/03/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
The participants in the trial must be HIV-1 infected, over 18 years of age, at any stage of HIV disease, but not acute symptomatic primary infection, where anti-retroviral therapy is indicated. Participants should be likely to take their first regimen for at least 6 months and be expected to adhere to the protocol.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1000
Participant exclusion criteria
1. The participants must not have received prior treatment with antiretroviral drugs or immunotherapy
2. There must be no history of peripheral neuropathy or pancreatitis
3. Individuals must not be receiving combination cytotoxic chemotherapy for cancer or parental therapy for an active opportunistic infection
4. Women should not be pregnant, breastfeeding or unwilling to use adequate contraception
5. Participants will be ineligible if biochemistry and haematology blood results from screening are outside the trial upper safety limits.
Recruitment start date
01/03/1999
Recruitment end date
31/03/2001
Locations
Countries of recruitment
Australia, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, New Zealand, Portugal, Spain, Sweden, Switzerland, United Kingdom
Trial participating centre
MRC CTU
London
NW1 2DA
United Kingdom
Funders
Funder type
Industry
Funder name
The trial was supported with respect to funding, antiretroviral drugs, viral load assays and resistance assays by:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Dupont
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
Funder name
Hoffman-La Roche
Alternative name(s)
Hoffman-La Roche, F. Hoffmann-La Roche Ltd.
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
Switzerland
Funder name
Merck
Alternative name(s)
Merck & Co., Inc.
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
Funder name
Bristol Meyers Squibb
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Medical Research Council
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Funder name
GlaxoSmithKline
Alternative name(s)
GlaxoSmithKline plc., GSK
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United Kingdom
Funder name
Virco
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/16860698
Publication citations
-
Results
, Yeni P, Cooper DA, Aboulker JP, Babiker AG, Carey D, Darbyshire JH, Floridia M, Girard PM, Goodall RL, Hooker MH, Mijch A, Meiffredy V, Salzberger B, Virological and immunological outcomes at 3 years after starting antiretroviral therapy with regimens containing non-nucleoside reverse transcriptase inhibitor, protease inhibitor, or both in INITIO: open-label randomised trial., Lancet, 2006, 368, 9532, 287-298, doi: 10.1016/S0140-6736(06)69074-0.