NCT00772590

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

Randomised Double-blind Placebo Controlled Study to Measure the Effect of Antiretroviral Therapy (ART) Intensification With Raltegravir and/or Hyper-immune Bovine Colostrum on CD4+ T Cell Count in ART Treated, HIV-1 Infected Individuals With Suboptimal CD4+ T Cell Responses

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Kirby Institute · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of this study is to measure the effect on CD4+ T cell outcome as measured by the mean time weighted CD4+ T cell count change over 24 weeks of two interventions: (I) cART intensification with raltegravir and (II) cART combined with hyper-immune bovine colostrum in HIV-1 infected individuals who have failed to achieve a CD4+ T cell count greater than 350 cells/µL despite persistent HIV plasma viraemia below 50 copies/mL on cART. Eligible patients will be randomised to one of four arms. I. Raltegravir + hyper-immune bovine colostrum placebo II. Raltegravir placebo + hyper-immune bovine colostrum III. Raltegravir + hyper-immune bovine colostrum IV. Raltegravir placebo + hyper-immune bovine colostrum placebo

Conditions

• HIV Infections

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-03-01
• Completion: 2011-06-01
• First posted: 2008-10-15
• Last updated: 2012-08-24
• Results posted: 2012-08-24