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Antiretroviral Therapy Intensification With Raltegravir or Addition of Hyper-immune Bovine Colostrum in HIV-1 Infected Patients With Suboptimal CD4+ T Cell Response

NCT00772590 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2012-08-24

Study results available
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Summary

A research study to measure the effect on CD4 counts of adding to current anti-retroviral regimen raltegravir with or without hyper-immune bovine colostrum.

Conditions

  • HIV Infections

Interventions

DRUG

Raltegravir

Tablets, 400mg, twice daily

DRUG

Hyper-immune Bovine Colostrum

Tablet, 1800mg, twice daily

OTHER

raltegravir placebo

One tablet, twice daily

OTHER

Hyper-immune Bovine Colostrum placebo

Three tablets twice daily

DRUG

raltegravir and hyper-immune bovine colostrum

400mg twice daily raltegravir and 1800mg twice daily of hyper-immune bovine colostrum

Sponsors & Collaborators

  • Kirby Institute

    lead OTHER_GOV

Principal Investigators

  • Sean Emery, BSc (Hons), PhD · National Centre in HIV Epidemiology and Clinical Research, University of New South Wales

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-03-31
Completion
2011-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00772590 on ClinicalTrials.gov