Clinical trial NCT01195077: Could Dietary Algae Affect Immunity and Viral Counts in People With HIV?
Official title: Could Dietary Algae Affect Immunity and Viral Counts in People With HIV?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV Infections
Keywords: HIV
Dietary intervention
Algae
HIV progression
Algae specific kind
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2010-09-03
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Drawing inferences from epidemiologic studies of HIV/AIDS as well well as cell culture and animal studies of HIV inhibition by algae, we propose algal consumption as one unifying characteristic of countries with anomalously low rates. HIV/AIDS incidence and prevalence in Eastern Asia (\<1/10,000 adults in Japan and Korea), compared to Africa (≈1/10 adults) strongly suggest that differences in IV drug use and sexual behavior are insufficient to explain the 1000-fold variation. Even in Africa, AIDS/HIV rates vary. Spirulina is part of the daily diet for many people living in Chad, where prevalence of HIV has remained at less than 4% for more than 20 years. Average daily algae consumption in Asia and Africa ranges between 1 to 2 tablespoons (3 - 13 grams).

HIV viral load is the main indicator of infection, however CD4 helper cell counts are most predictive of morbidity and mortality.We hypothesized that the consumption of algae could be important in diminishing the risk of HIV infection, and subsequent progression, possibly by enhancing the immune response.

Detailed description: Twelve HIV+ patients not on antiretroviral therapy were clinically evaluated and enrolled in the three-week study. Subjects received 10 algae capsules/d. Laboratory tests of CD4 counts and HIV RNA were performed at baseline, week 1, week 2, and week 3, and then once a month. Six subjects continued for between 4 and 14 months. In addition to CD4 lymphocyte counts and viral loads, subjects were evaluated monthly for Complete Blood Counts (CBC), Liver profile, Basic Metabolic Panel, and some subjects were evaluated for thyroid function and cholesterol. All subjects completed standard HIV Quality of Life questionnaires at each clinic visit.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of HIV
* Able to swallow pills

Exclusion Criteria:

* Allergy to iodine/seafood
* Thyroid disease
* Not taking antiretroviral therapy

Primary outcomes:
measure: Dietary algae influence on CD4 helper cells and HIV viral load
timeFrame: Once a week for first 3 weeks, then once a month
Secondary outcomes:
measure: Would seaweed (Undaria) or spirulina or a combination of the two algae have more benefit?
timeFrame: Participants were randomized to one of 3 treatments.
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Cancer Prevention and Control Program/University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Jane Teas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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