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Clinical Trials/ISRCTN81868024
ISRCTN81868024
Completed
Not Applicable

A randomised, double-blind, controlled study on the effect of one year administration of a nutritional concept on immunological status in human immunodeficiency virus-1 positive adults not on anti-retroviral therapy

umico Research B.V. (The Netherlands)0 sites800 target enrollmentFebruary 26, 2007
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ConditionsHIVInfections and Infestations

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV
Sponsor
umico Research B.V. (The Netherlands)
Enrollment
800
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 26, 2007
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional

Investigators

Sponsor
umico Research B.V. (The Netherlands)

Eligibility Criteria

Inclusion Criteria

  • •Main inclusion criteria:
  • •1\. HIV\-1 positive adults who have not received (Highly Active) Anti\-Retroviral Therapy (\[HA]ART) in the past year and are not anticipated to start therapy within the next six months
  • •2\. HIV\-1 Ribonucleic Acid (RNA) more than 5,000 copies/ml in the three months prior to screening visit
  • •3\. CD4\+ T\-cell count less than or equal to 800 cells/µl in the three months prior to screening visit
  • •4\. More than or equal to 18 years old

Exclusion Criteria

  • •Main exclusion criteria:
  • •1\. (HA)ART anticipated to be required within the next six months
  • •2\. Unintended weight loss of more than 10% in the three months prior to screening visit

Outcomes

Primary Outcomes

Not specified

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