Lactoferrin Treatment in HIV Patients

Jason Baker

Status and phase: Completed; Phase 2

Conditions: HIV Infection

Treatments: Drug: Placebo; Drug: Recombinant Lactoferrin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01830595

PCC-006

Details and patient eligibility

About

Our general goal is to evaluate the potential effectiveness of recombinant lactoferrin (1500mg bid) for reducing inflammation among HIV positive participants.

Enrollment: 55 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. HIV-positive participants receiving Antiretroviral Therapy (ART) for >1 year
2. HIV RNA level <200 copies/mL for at least 6 months (≥2 separate values)
3. Age >40 years

Exclusion criteria

1. Prior cardiovascular disease or stroke
2. Diabetes
3. Rheumatologic Diseases
4. Pregnancy
5. Chronic kidney disease, stage IV or V (creatinine clearance <30 mL/min/1.73m2)
6. Cirrhosis or end-stage liver disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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55 participants in 2 patient groups, including a placebo group

Recombinant Lactoferrin

Active Comparator group

Description:

Recombinant lactoferrin will be administered by mouth twice daily

Treatment:

Drug: Recombinant Lactoferrin

Placebo

Placebo Comparator group

Description:

Matched placebo will be administered by mouth twice daily

Treatment:

Drug: Placebo