AIDS, HIV, Immunological Deficiency, Inadequate Immune Recovery, Viral Replication
Conditions
Keywords
HIV, AIDS, zinc, zinc supplement, immunological deficiency
Brief summary
INTRODUCTION: An adequate zinc supplementation is essential for a good immunological function. However, zinc deficiency is seen in more than 50% of adults infected with HIV. The safety and efficiency of zinc supplements in the progression of HIV is evaluated in the short-term. HYPOTHESIS Null hypothesis: Zinc supplementation does not improve the immunological recovery of HIV patients after three months of daily consumption. Alternate hypothesis: Zinc supplementation improves the immunological recovery of HIV patients after three months of daily consumption
Detailed description
GOAL: To assess the effect of zinc supplementation in the natural history of HIV, emphasizing on the immunological recovery of patients in a health care provider program in Medellín in 2012. METHODS: A prospective, randomized, double-blind, controlled clinical trial will be conducted. The selected group will consist of male and female patients over 18 years of age, who comply with the inclusion criteria, with digital clinical history, in an HIV/AIDS program of a health care provider in Medellín. They will receive zinc supplements for 3 months. A comparison will be made between the immunological recovery among those patients taking the zinc supplement and those who are not. The CD4 lymphocytes value will be taken as an independent variable.
Interventions
DIETARY_SUPPLEMENTZinc supplementation
Intervention group A: Patients who will orally receive zinc for 3 months.
DIETARY_SUPPLEMENTPlacebo supplementation
Intervention Group B: Patients who will orally receive a placebo for 3 months.
Sponsors
IPS Fundación SIAM
CES University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults suffering from HIV/AIDS, over 18 years of age with first- and second-line antiretroviral therapy. * Patients with two viral loads less than 40 copies/ml (viral supression) and a stable or inferior CD4 lymphocyte count. * Patients with body mass index over 18.5 kg/m2. * Patients without opportunistic diseases.
Exclusion criteria
* Pregnant women. * Hospitalized patients with cognitive disability evaluated by a doctor. * Patients who are unwilling to participate. * Patients taking zinc supplements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunological Recovery | Three months | Zinc supplementation is expected to enhance the immunological response of HIV+ patients. This can be demonstrated comparing the initial analysis with the final report (3 months later). |
| EFFECT OF ZINC SUPPLEMENTATION ON IMMUNE RECOVERY PROGRAM HIV PATIENTS | THREE MONTHS | Compare the variation in levels of CD4 lymphocytes at baseline and three months after surgery (zinc or placebo) in each study patient. |
Countries
Colombia
Contacts
Primary ContactMARCELA DUQUE
Backup ContactHEIDY CONTRERAS
Outcome results
None listed