Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Contact information



Primary contact

Prof Jonathan Weber


Contact details

Imperial College of Sci Tech & Med
Medical School
Wright-Fleming Institute
Norfolk Place
W2 1PG
United Kingdom
+44 (0)20 7594 3905

Additional identifiers

EudraCT number

2004-000446-20 number

Protocol/serial number


Study information

Scientific title

Short Pulse AntiRetroviral Therapy At human infection immunodeficiency virus (HIV) seroConversion: a Multicentre randomised trial of therapeutic intervention at primary HIV-1 infection



Study hypothesis

The study is a randomised controlled trial comparing three different strategies of intervention in Primary Human Immunodeficiency Virus (HIV) Infection (PHI). The primary objective is to determine the effect of two anti-HIV treatment schedules of limited duration in PHI on the rate of CD4 decline and, consequently, on the time to initiating long-term anti-HIV therapy. The secondary objective is to evaluate the effect of different durations of treatment during PHI on HIV-specific immune response and disease progression. The aim of early antiretroviral intervention is to preserve HIV-specific CD4+ T-cell responses from HIV-induced lysis in order to confer enhanced control of viral replication when therapy is subsequently discontinued.

Ethics approval

The London Multicentre Research Ethics Committee (MREC), 29/07/2004, ref: 04/2/025

Study design

Multicentre randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact to request a patient information sheet


Human immunodeficiency virus (HIV)


Participants will be randomly allocated in a 1:1:1 ratio at trial entry to start one of the regimens of open treatment with:
Arm A: Long course Combination AntiRetroviral Therapy (LCART) for 48 weeks
Arm B: Short course Combination AntiRetroviral Therapy (SCART) for 12 weeks
Arm C: No antiretroviral therapy

The regimen should be started, ideally, on the day of randomisation, or within 72 hours.

Intervention type



Not Applicable

Drug names

Primary outcome measure

Time to CD4 cell count less than 350 cells/l (excluding counts in the first three months after diagnosis) on two consecutive occasions not more than four weeks apart. Intervention at PHI is termed PTX (primary treatment) to distinguish it from late treatment (LTX), which may be administered according to local HIV treatment guidelines when indicated.

Secondary outcome measures

1. HIV-specific CD4+ and CD8+ T-cell responses at week 60
2. Slope of CD4 decline
3. Time from randomisation to virological failure of first regimen of late treatment (LTX) or death
4. Development of drug resistance not present at baseline, before starting LTX or at week 120 whichever is earlier
5. Development of an AutoImmune Deficiency Syndrome (AIDS) defining illness or death
6. Time from randomisation to the initiation of late treatment (LTX)
7. Differences in blood pressure from randomisation at week 12 and week 48

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Patients of both sexes will be eligible for screening if they:
1. Have reached the age of consent in their country for participating in a clinical study
2. Are confirmed PHI by at least one of following criteria:
2.1. HIV positive antibody test within six-months of an HIV negative antibody test (randomisation must take place within six months of previous negative test)
2.2. HIV antibody negative with positive Reverse Transcription Polymerase Chain Reaction (RT-PCR)
2.3. Test 'incident' at low level (less than 0.6) using detuned assay (must be subtype B)
2.4. Equivocal HIV antibody test supported by a repeat test within a two-week period showing a rising optical density
2.5. Have clinical manifestations of symptomatic HIV seroconversion illness supported by antigen positivity and less than four bands positive on Western Blot
3. Able and willing to give written informed consent

Participant type


Age group




Target number of participants


Participant exclusion criteria

Patients will not be eligible for screening if:
1. Pregnant
2. Unlikely to comply with protocol, and in particular adhere to therapeutic regimen
3. Likely to use narcotics during the study period
4. Antiretroviral therapy is indicated
5. Antiretroviral therapy is contraindicated

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Imperial College of Sci Tech & Med
W2 1PG
United Kingdom

Sponsor information


Imperial College London (UK)

Sponsor details

Level 2
Faculty Building
Clinical Research Office
South Kensington campus
United Kingdom

Sponsor type




Funder type


Funder name

Wellcome Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

International organizations


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

Basic results (scientific)

Publication list

2013 results in:
2013 results in:
2014 results in:

Publication citations

  1. Results

    , Fidler S, Porter K, Ewings F, Frater J, Ramjee G, Cooper D, Rees H, Fisher M, Schechter M, Kaleebu P, Tambussi G, Kinloch S, Miro JM, Kelleher A, McClure M, Kaye S, Gabriel M, Phillips R, Weber J, Babiker A, Short-course antiretroviral therapy in primary HIV infection., N. Engl. J. Med., 2013, 368, 3, 207-217, doi: 10.1056/NEJMoa1110039.

  2. Results

    Frater J, Ewings F, Hurst J, Brown H, Robinson N, Fidler S, Babiker A, Weber J, Porter K, Phillips RE, HIV-1-specific CD4+ responses in primary HIV-1 infection predict disease progression., AIDS, 2014, 28, 5, 699-708, doi: 10.1097/QAD.0000000000000130.

  3. Results

    Stöhr W, Fidler S, McClure M, Weber J, Cooper D, Ramjee G, Kaleebu P, Tambussi G, Schechter M, Babiker A, Phillips RE, Porter K, Frater J, Duration of HIV-1 viral suppression on cessation of antiretroviral therapy in primary infection correlates with time on therapy, PLoS One, 2013 , 8, 10, e78287, doi: 10.1371/journal.pone.0078287.

Additional files

Editorial Notes