Short pulse antiretroviral therapy at HIV seroconversion:A multi-centre randomised trial of therapeutic intervention at primary HIV-1 infection. Tratamiento antirretroviral en pulsos cortos en la seroconversión por el VIH: ensayo clínico aleatorizado, multicéntrico, de intervención terapéutica en la infección primaria por VIH-1. - SPARTAC

Phase 1

• Conditions: primary HIV infection infección primaria por el VIH; MedDRA version: 9.1 Level: LLT Classification code 10058427 Term: Primary HIV infection

• Registration Number: EUCTR2004-000446-20-ES
• Lead Sponsor: Imperial College

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-05-23
• Study Completion: 2011-01-31
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 371

Inclusion Criteria

1. Have reached the age of consent in their country for participating in a clinical study

2. Are confirmed primary HIV infection by at least one of the following criteria:
- HIV positive antibody test within 6 months of an HIV negative antibody test
- HIV antibody negative with positive RT-PCR test
- Test incident at low level (<0.6) using detuned assay (must be subtype B)
- Equivocal HIV antibody test supported by a repeat test within a 2 week period showing a rising optical density
- Have clinical manifestations of symptomatic HIV seroconversion illness supported by antigen positivity and <4 bands on Western Blot

3. Are able and willing to give written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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 clinical trial of medicinal product
• Study Design: Not specified