Antiretroviral therapy intensification with raltegravir and/or hyper-immune bovine colostrum in Human Immunodeficiency Virus-1 (HIV-1) infected patients with suboptimal immunological response

Phase 3

Active, not recruiting

• Conditions: Human Immunodeficiency Virus (HIV)Infection; Infection - Acquired immune deficiency syndrome (AIDS / HIV)

• Registration Number: ACTRN12609000575235
• Lead Sponsor: niversity of New South Wales (UNSW)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1.Documented HIV-1 infection
2. Age >18 years
3.Signed informed consent
4.Receiving combination ART for at least 12 months with a stable cART regimen for a minimum of 6 months.
5.Two consecutive plasma HIV RNA viral load measurements <50 in the 9 months preceding the screening visit.
6.CD4+ T cell count <350 cells/µL throughout the 6 months preceding the screening visit with <50 cells/µL increase in the last 12 months

Exclusion Criteria

1.Receiving a cART regimen containing an integrase inhibitor
2.Anticipated change of cART in the 24 weeks following randomisation
3.Participating in study with an investigational compound or device within 30 days of signing informed consent
4.Use of immune modulating therapies or immunosuppressive medications within 60 days prior to study entry. Patients using inhaled or nasal steroids are not excluded
5.Pregnant or breastfeeding woman
6.Cow’s milk allergy
7.Concurrent treatment with phenobarbitol, phenytoin or rifampicin.
8.A known cause of impaired CD4+ T cell gain: for example individuals whose current cART regimen contains both tenofovir and didanosine

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline of CD4+ T cell count of comparisons 1) raltegravir versus placebo and 2) hyper-immune bovine colostrum versus placebo as measured in peripheral blood[Primary assessment will be done at 24 weeks from baseline]

Secondary Outcome Measures

Name	Time	Method
Change in T cell count, T cell percentage, activated T cells, microbial translocation markers, plasma HIV Ribonucleic Acid (RNA) - with limit of detection of 0.4 HIV RNA copies/mL, immune activation markers and proportion of patients with CD4+ T cells greater than 350 cells/microlitre over 48 weeks[24 weeks and 48 weeks from baseline]