HIV, Immune Activation and Salt Sensitive Hypertension

Study Overview
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Brief Summary
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High dietary salt is associated with immune activation, elevated levels of inflammatory cytokines and hypertension in murine models. Hypertension is independently associated with inflammation in both murine studies and studies in humans. In people living with HIV, these interactions are not well established. The aim of this study is to determine the effect of excess dietary salt on immune cell activation, pro- and anti-inflammatory cytokines and blood pressure between individuals with and without hypertension among people living with HIV and HIV negative persons.

Official Title
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Hypertension, Dietary Salt and Inflammation

Conditions
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HIV-1-infection, Hypertension,Essential

Intervention / Treatment
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* Dietary Supplement: Dietary salt (Sodium chloride)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (aged 18 and above) who will be required to verbally consent and sign a consent form HIV positive or HIV Normotensive individuals or hypertensive If HIV, on antiretroviral therapy ART treated hypertensive individuals Exclusion Criteria: Existence of comorbidities such as diabetes mellitus and cancer Existing and recent past opportunistic infections, syphilis, hepatitis C and B virus infection and tuberculosis infection; Sick persons (clients seeking healthcare due to an illness rather than routine ART clinic reviews) Those with recent and current alcohol consumption and smoking status

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants are instructed on salt deprivation for a week followed by a low salt (4 grams) diet for one week and switched to high salt (9 grams) for the following one week
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIV+ Hypertensive<br>Participants receive 4 grams of dietary salt (equivalent of 1, 560 mg sodium) everyday for seven days followed by 9 grams (equivalent of 3, 510 mg sodium) of dietary salt for the following seven days | Dietary Supplement: Dietary salt (Sodium chloride)<br>* Dietary salt used was sodium chloride tablets (from the research consolidated midland corporation division, New York, USA) which participants crashed and put in their food and/or ingested. Each tablet weighed one (1) gram and contained 394 mg of sodium and 606 mg of chloride.<br>|
| Other: HIV+ Normotensive<br>Participants receive 4 grams of dietary salt (equivalent of 1, 560 mg sodium) everyday for seven days followed by 9 grams (equivalent of 3, 510 mg sodium) of dietary salt for the following seven days | Dietary Supplement: Dietary salt (Sodium chloride)<br>* Dietary salt used was sodium chloride tablets (from the research consolidated midland corporation division, New York, USA) which participants crashed and put in their food and/or ingested. Each tablet weighed one (1) gram and contained 394 mg of sodium and 606 mg of chloride.<br>|
| Experimental: HIV- Hypertensive<br>Participants receive 4 grams of dietary salt (equivalent of 1, 560 mg sodium) everyday for seven days followed by 9 grams (equivalent of 3, 510 mg sodium) of dietary salt for the following seven days | Dietary Supplement: Dietary salt (Sodium chloride)<br>* Dietary salt used was sodium chloride tablets (from the research consolidated midland corporation division, New York, USA) which participants crashed and put in their food and/or ingested. Each tablet weighed one (1) gram and contained 394 mg of sodium and 606 mg of chloride.<br>|
| Other: HIV- Normotensive<br>Participants receive 4 grams of dietary salt (equivalent of 1, 560 mg sodium) everyday for seven days followed by 9 grams (equivalent of 3, 510 mg sodium) of dietary salt for the following seven days | Dietary Supplement: Dietary salt (Sodium chloride)<br>* Dietary salt used was sodium chloride tablets (from the research consolidated midland corporation division, New York, USA) which participants crashed and put in their food and/or ingested. Each tablet weighed one (1) gram and contained 394 mg of sodium and 606 mg of chloride.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pro-inflammatory cytokines | Elevated levels of pro-inflammatory cytokines when compared between low and high salt phase | 2 weeks: At the end of the low- and high-salt phases | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Elevated blood pressure | 2 weeks: At the end of the low- and high-salt phases | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammation, Human immunodeficiency virus (HIV), Salt, Interleukin 6, Interleukin 17A, Hypertension