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Clinical Trials/EUCTR2004-000446-20-IE
EUCTR2004-000446-20-IE
Active, not recruiting
Not Applicable

A multi-centre randomised trial of therapeutic intervention at primary HIV-1 infection - SPARTAC

Imperial College0 sites360 target enrollmentJune 8, 2006
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ConditionsHIV infectionMedDRA version: 8Level: LLTClassification code 10020161

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV infection
Sponsor
Imperial College
Enrollment
360
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 8, 2006
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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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