Antiretroviral therapy intensification with raltegravir and/or hyper-immune bovine colostrum in Human Immunodeficiency Virus-1 (HIV-1) infected patients with suboptimal immunological 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, Human Immunodeficiency Virus-1 (HIV-1) infected individuals with suboptimal CD4+ T cell responses despite prolonged virologic suppression

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000575235

Acronym

CORAL

Enrollment

Registered

2009-07-14

Start date

2009-03-16

Completion date

Unknown

Last updated

2026-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

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 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.

Interventions

Intensification of antiretroviral therapy with oral raltegravir and or oral hyper-immune bovine colostrum 48 weeks. Particiapants be be randomly allocated to one of four arms of the study I. Raltegravir 400mg (1 tablet) twice daily + hyper-immune bovine colostrum placebo (3 tablets) twice daily II. Raltegravir placebo (1 tablet) twice daily + hyper-immune bovine colostrum 1800mg (3 tablets) twice daily III. Raltegravir 400mg (1 tablet) twice daily + hyper-immune bovine colostrum 1800mg (3 tablet

Study design

Allocation

Randomised controlled trial

Intervention model

Factorial

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results