The SPARTAC Trial: a multicentre randomised trial of therapeutic intervention at primary human infection immunodeficiency virus-1 (HIV-1) infectio

Completed

Conditions: Human immunodeficiency virus (HIV)
Infections and Infestations
Virus

Registration Number: ISRCTN76742797

Lead Sponsor: Imperial College London (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 360

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:
a. HIV positive antibody test within six-months of an HIV negative antibody test (randomisation must take place within six months of previous negative test)
b. HIV antibody negative with positive Reverse Transcription Polymerase Chain Reaction (RT-PCR)
c. Test 'incident' at low level (less than 0.6) using detuned assay (must be subtype B)
d. Equivocal HIV antibody test supported by a repeat test within a two-week period showing a rising optical density
e. 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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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