NCT01195077

Could Dietary Algae Affect Immunity and Viral Counts in People With HIV?

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
OTHER	seaweed, spirulina, seaweed + spirulina	Arm 1: Seaweed. Ten capsules of .5 grams per capsule for a total of 10 grams per day. Arm 2: Spirulina: Ten capsules of .5 grams per capsule for a total of 10 grams per day. Arm 3: Seaweed: (2.5 grams) plus Spirulina (2.5 grams). Ten capsules of .5 grams per capsule for a total of 10 grams per day. Spirulina: Ten capsules of .5 grams per capsule for a total of 10 grams per day.

Timeline

• Start date: 2003-02-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2010-09-03
• Last updated: 2021-05-11

Locations

1 site across 1 country: United States