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Clinical Trials/EUCTR2004-000446-20-ES
EUCTR2004-000446-20-ES
Active, not recruiting
Phase 1

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

Imperial College0 sites371 target enrollmentMay 23, 2007
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Conditionsprimary HIV infection infección primaria por el VIHMedDRA version: 9.1 Level: LLT Classification code 10058427 Term: Primary HIV infection

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
primary HIV infection infección primaria por el VIH
Sponsor
Imperial College
Enrollment
371
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 23, 2007
End Date
January 31, 2011
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Imperial College

Eligibility Criteria

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:

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

Outcomes

Primary Outcomes

Not specified

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