Condition category
Infections and Infestations
Date applied
06/09/2005
Date assigned
28/09/2005
Last edited
10/07/2014
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.ctu.mrc.ac.uk/initio/

Contact information

Type

Scientific

Primary contact

Prof Abdel Babiker

ORCID ID

Contact details

MRC CTU
222 Euston Road
London
NW1 2DA
United Kingdom

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 measures

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

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

Sponsor information

Organisation

Medical Research Council (UK)

Sponsor details

20 Park Cresent
London
W1B 1AL
United Kingdom

Sponsor type

Research council

Website

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

corporate

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

corporate

Location

Switzerland

Funder name

Merck

Alternative name(s)

Merck & Co., Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

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

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

GlaxoSmithKline

Alternative name(s)

GlaxoSmithKline Plc., GSK

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

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

Results - basic reporting

Publication summary

2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/16860698

Publication citations

  1. 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.

Additional files

Editorial Notes