The study authors noted that the study did not include children with advanced HIV but rather children with proper immune function and relatively high CD4 (white blood cell) counts. The authors also pointed out that vitamin D insufficiency is common in children with HIV and recommended daily dosages of 1,000 to 2,000 International Units (25 to 50 micrograms) of vitamin D to maintain proper bone health, which is higher than the Institute of Medicine’s recommended daily dose of 600 IU for children.

“Vitamin D status evaluation/supplementation should be part of routine care. Some caregivers may prefer testing and then electively treating, others may prefer to simply supplement automatically (in standard doses),” said Dr. Ari Bitnun, lead investigator of the study, in correspondence with the AIDS Beacon.

“Future potential research includes evaluating the impact of vitamin D in individuals with more advance disease, and a better understanding of the role of vitamin D on the immune system in general,” he added.

Vitamin D, which can be obtained from sunlight, diet, and vitamin supplements, is important for the absorption of calcium, bone formation, muscle strength, reduction of inflammation, and for a healthy immune system.

People living with HIV often have lower levels of vitamin D, and studies have shown that people with HIV who are taking antiretrovirals are more prone to vitamin D deficiencies (see related AIDS Beacon news).

According to the study authors, previous studies have also shown that low vitamin D levels are associated with faster HIV progression and increased risk of death, although the reason for this is not clear. Some studies have found that vitamin D supplementation may help increase CD4 counts, which could help decrease progression and risk of death; however, results have been conflicting.

In this study, researchers investigated the influence of vitamin D supplementation on CD4 count in children with HIV. The study included 53 children aged 3 to 18 years old. The children were monitored for six months.

The researchers randomly assigned the children to one of three groups: one group received 5,600 International Units (IU) of vitamin D once per week (equivalent to 800 IU daily), one group received 11,200 IU of vitamin D once per week (equivalent to 1,600 IU daily), and one group did not receive vitamin D.

The authors assessed the children’s viral loads (amount of HIV in the blood), CD4 percentages, and CD4 counts. CD4 cell percentages (the fraction of white blood cells that are CD4 cells, the cells targeted by HIV) are sometimes used in children because they vary less by age; normal CD4 cell percentages should be above 25 percent.

The authors also assessed the children’s levels of vitamin D metabolites, which are a measure of how much active vitamin D is in the bloodstream, to characterize any vitamin D deficiencies.

At the start of the study, 85 percent of the children had insufficient vitamin D levels.

Results showed that after six months, vitamin D metabolite levels increased significantly in children who received vitamin D compared to children who did not receive vitamin D. Overall, 39 percent of children in the 5,600 IU group and 67 percent of children in the 11,200 IU group achieved vitamin D sufficiency.

However, the researchers found no difference in the children’s CD4 counts, CD4 percentages, or viral loads over the course of the study.

The researchers speculated that any effects vitamin D may have on CD4 counts are not evident in children whose immune systems are still relatively healthy.

They suggested that additional studies focus on determining the optimal vitamin D supplement dose for children with HIV to sufficiently support bone and immune system health.

For more information, please see the study in the Journal of Pediatrics (abstract).

However, the researchers noted that the supplement did not significantly affect study participants’ viral loads (amount of HIV in the blood) or CD4 (white blood cell) counts.

The results were presented at the 6th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention (IAS 2011) in Rome last month.

Micronutrients are minerals and vitamins that are needed in small amounts to maintain proper health. Examples of micronutrients include vitamin C and zinc, which are important for immune function; potassium and sodium, which are important for heart and nerve function; and calcium, which is important for bone health.

Previous studies have indicated that nutrient deficiencies and unintentional weight loss are common in people with HIV, possibly due to poor absorption of nutrients in the intestines (as a result of HIV or opportunistic infections of the gut); poor diet; or gastrointestinal problems such as vomiting, diarrhea, or loss of appetite, which can be caused by HIV or can be side effects of antiretrovirals.

Additionally, past studies have shown that nutritional deficiencies are associated with a higher rate of opportunistic infections, faster progression of HIV, and HIV-related deaths.

Several clinical trials conducted in HIV-positive patients have shown that participants taking micronutrient supplements may have improved clinical outcomes, such as increased CD4 counts, slower disease progression, and decreased mortality.

For example, a study conducted in 2006 showed that participants taking a micronutrient supplement formulated for immunocompromised people had significantly increased CD4 counts compared to participants not taking the supplement.

In the current study, researchers investigated whether taking K-PAX, a commercially available micronutrient supplement for people with compromised immune systems, would affect health outcomes in 60 HIV-positive individuals. K-PAX contains a variety of antioxidants, vitamins, and minerals, such as zinc and selenium, that, according to some studies, may help boost the immune system.

The study included 51 men, 8 women, and 1 transgender individual. The average age of participants was 48 years. Almost all (90 percent) of participants were on antiretroviral therapy, and 58 percent had undetectable viral loads at the beginning of the study.

All study participants took K-PAX for six months. During this time the researchers recorded participants’ viral loads, CD4 counts, and body weight.

Results showed that participants’ viral loads decreased, although not significantly. The average viral load at the beginning of the study was approximately 315 copies per milliliter of blood, compared to 254 copies per milliliter of blood after six months of K-PAX use.

The use of K-PAX also resulted in a slight but not significant decrease in participants’ CD4 cell counts. The average CD4 count before K-PAX use was 426 cells per microliter of blood, compared to 414 cells per microliter of blood after six months of K-PAX use.

However, results also showed that participants’ body weight increased after six months of K-PAX use, with an average increase in weight of three pounds.

For more information, please see the study abstract and poster on the IAS 2011 conference website.

Based on their results, the study authors recommended that people with HIV be monitored for vitamin D deficiencies and given supplements or alternate antiretroviral regimens if severe deficiencies develop.

People living with HIV often have lower levels of vitamin D, which is an important vitamin obtained from sunlight, diet, and vitamin supplements.

Vitamin D is important for the absorption of calcium, bone formation, muscle strength, reduction of inflammation, and for a healthy immune system.

Studies have shown that very low vitamin D levels are associated with a greater risk of osteoporosis, muscle weakness, and certain types of cancers. Studies have also shown that people with HIV who are taking antiretrovirals are more prone to vitamin D deficiencies (see related AIDS Beacon news).

In this study, researchers aimed to determine whether vitamin D deficiencies are associated with particular antiretrovirals and if switching treatments could help alleviate the deficiencies.

At the beginning of the study, participants’ vitamin D levels were measured by blood tests. All 219 study participants were taking antiretroviral drugs at the time. All regimens included at least two nucleoside reverse transcriptase inhibitors (NRTIs).

Participants then switched to treatment with Prezista (darunavir) boosted with Norvir (ritonavir). Participants either took Prezista plus Norvir alone or in combination with two NRTIs.

After two years, the participants’ vitamin D levels were measured again and compared to levels from the beginning of the trial.

Results showed that at the beginning of the study, low vitamin D levels were associated with winter months, being black, and taking Sustiva (efavirenz) or zidovudine (Retrovir).

By the end of the trial, there were fewer study participants with severe vitamin D deficiency than there were at the start of the study. This was true regardless of participants’ initial antiretroviral regimen; however, the increases were greatest for those who had switched from Sustiva or zidovudine.

Participants switching from Sustiva or zidovudine had average blood vitamin D levels increase around 40 percent over the two year period, compared to an average increase of less than 30 percent for other antiretrovirals.

The researchers noted that due to the long period of time between blood samples, it was not possible to evaluate how quickly vitamin D levels increased after switching treatment.

There were no differences in vitamin D levels between participants who took Prezista alone versus in combination with NRTIs.

For more information, please see the study in AIDS Research and Human Retroviruses.

Theratechnologies And Sanofi-Aventis Partner To Market Egrifta In Latin America, Africa, And The Middle East – Theratechnologies announced today that it has reached an agreement with Sanofi-Aventis for the introduction of Egrifta (tesamorelin) in Latin America, Africa, and the Middle East. Under the agreement, Theratechnologies will be responsible for producing Egrifta and conducting any additional clinical research, while Sanofi-Aventis will be in charge of obtaining regulatory approval and marketing the drug. Egrifta is used to reduce excess abdominal fat in people with HIV who suffer from lipodystrophy, a common side effect of antiretrovirals in which body fat is abnormally redistributed. Egrifta was approved by the U.S. Food and Drug Administration in November for sale in the U.S. (see related AIDS Beacon news). For more information, please see the press release on the Theratechnologies website.

Clinical Trial On Vitamin D Supplements In People With HIV Is Now Recruiting – A new clinical trial studying the effects of vitamin D supplementation in vitamin D deficient HIV-positive adults is now recruiting participants in Los Angeles. Participants will receive 50,000 IU of vitamin D twice weekly for 5 weeks, followed by 2,000 IU daily for 7 weeks. The current vitamin D recommendation for adults is 600 IU daily. The study aims to see if high doses of vitamin D can effectively eliminate deficiencies in trial participants. Vitamin D deficiencies are thought to contribute to bone loss, which is a common problem in people with HIV (see related AIDS Beacon news). Participants must be HIV positive, 18 to 90 years old, and have viral loads (amount of virus in the blood) of 200 copies per milliliter or less. Participants also cannot be taking vitamin D supplements and must be patients at the University of California, Los Angeles Center for Clinical AIDS Research & Education. For more information, please see the United States Clinical Trials Registry.

The researchers suggested that future studies evaluate whether taking vitamin D and calcium supplements can help alleviate high parathyroid hormone levels in people who take these antiretrovirals.

Parathyroid hormone is released by the parathyroid gland and is involved in regulating calcium and phosphorous levels in the body. Normally, parathyroid hormone is released when calcium levels are low to draw calcium from the bones into the bloodstream. If parathyroid hormone levels are chronically elevated, however, this can lead to bone loss and bone weakening over time.

Studies have shown that people with HIV who are on antiretroviral therapy have an increased risk of bone loss and fractures (see related AIDS Beacon news). In particular, Viread (tenofovir), which is also an ingredient in Truvada (emtricitabine/tenofovir), has been associated with the greatest bone loss in comparison to other antiretroviral medications.

Although the mechanism of this bone loss is not yet clear, Viread has also been associated with high parathyroid hormone levels.

In this study, researchers examined whether high parathyroid hormone levels in people who take Viread or Truvada are linked to low vitamin D levels. Vitamin D aids in the absorption of calcium in the body and is important for bone health. Low vitamin D levels may lead to calcium deficiencies, which could further elevate parathyroid hormone levels.

The study included 45 men receiving antiretroviral therapy. Of these, one participant was taking Viread, 32 participants were taking Truvada, and the other 12 were taking other antiretrovirals.

Consistent with previous studies, the researchers found that a third of the men taking Viread or Truvada had high parathyroid hormone levels. None of the men in the alternate treatment group had high parathyroid hormone levels.

Results also showed that average parathyroid hormone levels were higher in men with vitamin D deficiencies. The average parathyroid hormone level was 80 picograms per milliliter for men taking Viread or Truvada who were deficient in vitamin D, compared to 56 picograms per milliliter in men taking these antiretrovirals who did not have vitamin D deficiencies.

Overall, 41 percent of men who had vitamin D deficiencies and took Viread or Truvada also had high parathyroid hormone levels. None of the men taking Viread or Truvada who had normal vitamin D levels had high parathyroid hormone levels.

The researchers also found that vitamin D deficiencies were common in both treatment groups, at 83 percent, and were tied to daily vitamin D supplement use. Sixty-eight percent of the men who took vitamin D supplements had vitamin D deficiencies, compared to 96 percent of the men who did not take vitamin D supplements.

The researchers concluded that vitamin D supplements may help reduce the risk of high parathyroid hormone levels and resulting bone loss in people with HIV taking Viread or Truvada. However, they also noted that the study was small and other effects that could change parathyroid hormone levels, such as calcium intake, were not measured.

The researchers proposed that further studies be done to examine whether vitamin D and calcium supplements can aid patients with HIV who have high parathyroid hormone levels.

For more information, please see the study in AIDS Research and Human Retroviruses (abstract).

Studies Find That Vitamin A Increases The Amount Of HIV In Breast Milk – Researchers at the University of Michigan School of Public Health have found that vitamin A and beta-carotene supplements are not safe in HIV-positive women who are breastfeeding because they may increase the amount of HIV in breast milk, raising the risk of transmitting HIV to the baby. The researchers think the supplements may increase the risk of breast inflammation, which can allow small amounts of blood to leak into the milk. Breastfeeding is not recommended for women with HIV in the United States, but is recommended in places where clean drinking water is scarce as long as women are receiving antiretroviral therapy. For more information, please visit the University of Michigan website.

Coalition For A National AIDS Strategy To Host Webinars On The National HIV/AIDS Strategy – The Coalition for a National AIDS Strategy will host two identical webinars to provide more details about implementation of the National HIV/AIDS Strategy, which was introduced by President Obama on July 13. The presenters will cover the important aspects of the Strategy, current efforts in implementation, and the need for community advocacy. The 90 minute webinars will be held on Thursday, September 2 at 1 p.m. EST and Tuesday, September 7 at 6 p.m. EST. For more information, please visit the AIDS.gov website.

“The positive effect of micronutrient supplements in HIV patients goes beyond their positive effect on the immune system,” said Dr. Marianna Baum, Professor of Dietetics and Nutrition at Florida International University Stempel School of Public Health, in email correspondence with The AIDS Beacon.

“They improve mood, depression, quality of life, energy levels, capacity to exercise, and [illnesses] among other factors of daily living,” she added. Dr. Baum was the lead researcher on the studies.

The supplements in the studies contain micronutrients, which are vitamins and minerals that the body needs in very small amounts to produce enzymes, hormones, and other substances necessary for growth and development.

Although two of the studies are small and need to be confirmed by larger studies, results suggest that specific micronutrients may help improve immune system health of people living with HIV/AIDS.

Micronutrient Supplements May Slow HIV Disease Progression

The first study investigated whether micronutrient supplementation could improve immune function and delay the onset of AIDS in HIV-positive adults in Botswana. Results showed that supplementation with micronutrients was safe and significantly delayed the progression of HIV to AIDS.

The study enrolled 875 HIV-positive adults and was carried out over 24 months. Participants started with CD4 (white blood cell) counts greater than 350 cells per microliter. None were on antiretroviral therapy.

Participants were randomly assigned to receive either a placebo or a nutritional supplement containing vitamin B-complex, vitamins C and E, and selenium. Researchers then monitored the participants’ HIV disease progression by tracking their CD4 cell counts.

Participants whose CD4 counts dropped below 250 cells per microliter were diagnosed as having progressed to AIDS and were started on antiretroviral therapy.

Results showed that over the two-year study period, taking micronutrient supplements reduced the probability of a participant’s CD4 count falling below the 250 threshold by 38 percent.

The researchers concluded that supplements may increase the amount of time before people with HIV show symptoms or need to start antiretroviral therapy.

Additional studies are currently in progress on the effect of micronutrient supplementation on illness and mortality rates in people with HIV.

Zinc May Help Prevent Immune System Failure In HIV-Positive Adults

Results from this small study suggest that zinc supplementation is safe and may help prevent immune failure in HIV-positive adults on antiretroviral therapy.

Zinc is an important micronutrient that the body requires to develop CD4 cells and activate the immune system. Zinc is naturally found in beans, nuts, whole grains, and certain types of seafood, but can also be taken as a supplement in pill form.

Immune system failure occurs in people with HIV when their CD4 cell count is too low to protect the body from infection. When this happens, patients are at a greater risk of disease progression and death.

For the study, researchers monitored 40 HIV-positive adults who were on antiretroviral therapy and had achieved viral suppression (viral load, or amount of virus in the blood, of 50 copies per milliliter or less).

Participants were randomly assigned to receive either a zinc supplement or a placebo. CD4 cell counts and viral loads were monitored over 18 months. Immune system failure was defined as having a CD4 count of 200 cells per microliter or less.

By the end of the study, four participants in the placebo group (21 percent) experienced immune system failure. None of the participants taking zinc supplements experienced immune system failure.

The researchers concluded that zinc supplements may help maintain immune system health when taken with antiretroviral drugs. However, long-term studies with more participants are still needed to conclusively assess the benefits of zinc supplementation in people with HIV.

Antioxidants May Improve Immune Health And Reduce Mitochondrial Damage

This small study found that taking antioxidants may help improve immune system health and reduce mitochondrial damage.

Mitochondria are the power centers of cells. They provide the energy that cells need to move, divide, and perform other functions. HIV infection and long-term antiretroviral therapy have been associated with mitochondrial damage.

Antioxidants can help prevent damage to cells and mitochondria by scavenging free radicals – highly reactive chemicals that can damage DNA, proteins, and other biological molecules. Antioxidants are found in many fruits, vegetables, nuts, and some meats.

The purpose of this study was to see if antioxidants could help improve immune function and prevent mitochondrial damage in people with HIV who are taking antiretroviral drugs.

The study involved 25 HIV-positive adults on antiretroviral therapy. Participants were randomly assigned to receive either an antioxidant supplement or a placebo for 8 weeks. The supplement contained vitamin B-complex, vitamins C and E, zinc, selenium, N-acetyl cysteine, and α-lipoic acid.

Both groups were evaluated at the beginning and end of the study to gauge changes in CD4 count, viral load, mitochondrial damage, insulin levels, and body size and proportions.

Results showed that participants taking antioxidants had reduced mitochondrial damage compared to participants taking a placebo.

They also had small increases in the proportion of CD4 immune cells and small decreases in insulin resistance, although these were too small to be significant in this small study. There were no safety issues observed with the supplements.

The researchers concluded that antioxidants may help with immune system recovery and reduce mitochondrial damage in HIV-positive adults. However, long-term studies with more participants are still needed to confirm the benefits of antioxidant supplements in people with HIV.

For more information, please see the AIDS 2010 conference website.

Tibotec Pharmaceuticals Submits New Drug Application For Rilpivirine To Treat HIV – Tibotec Pharmaceuticals has submitted a new drug application to the U.S. Food and Drug Administration (FDA) for rilpivirine (TMC278), a new non-nucleoside reverse transcriptase inhibitor. Rilpivirine is being studied for once-daily use with other antiretroviral drugs in treatment-naive HIV-positive adults. The application is based on the results of two Phase 3 clinical trials evaluating rilpivirine plus Truvada (emtricitabine/tenofovir) versus Sustiva (efavirenz). Tibotec has also agreed to collaborate with Gilead Sciences to develop a once-daily combination pill of rilpivirine and Truvada. For more information, please see the Tibotec Pharmaceuticals website and press release.

FDA Warns Consumers Of Serious Harm From Drinking Miracle Mineral Solution – The FDA is warning consumers not to drink Miracle Mineral Solution, also known as Miracle Mineral Supplement (MMS). MMS is sold online and falsely claims to treat multiple diseases, including HIV/AIDS, hepatitis, and cancer. The supplement contains an industrial bleach that can cause serious illness or injury, including severe nausea, vomiting, and life-threatening low blood pressure caused by dehydration. The FDA has warned consumers who have MMS to stop using it immediately and throw it away. For more information, please see the FDA website.

Some Dietary Supplements For People With HIV May Be Contaminated And Unsafe – The September issue of Consumer Reports identifies 12 dietary supplements that consumers should avoid because of possible health risks to the heart, liver, and kidneys. The list includes supplements such as colloidal silver (also known as ionic silver, native silver, or silver in suspending agent) and germanium (also known as Ge, Ge-132, or germanium-132) that are commonly used by people with HIV. Supplement manufacturers are not required to demonstrate the safety and efficacy of their products, which can be contaminated with heavy metals, pesticides, or prescription drugs. Consumer Reports developed the harmful ingredient list with the Natural Medicines Comprehensive Database, an organization that researches and evaluates the safety and effectiveness of dietary supplements. For more information, please see the Consumer Reports website.

The study examined 884 HIV-infected pregnant women who were enrolled in a multivitamin supplementation trial that did not include vitamin D. After following these women for 69.5 months, researchers recorded information on HIV disease progression, hemoglobin levels, and mortality. Later, they connected this information with the vitamin D status of the women.

At the conclusion of the study, researchers found an association between low vitamin D status and progression to World Health Organization HIV stage III disease. Women with low vitamin D status also had a 46 percent increased risk of developing severe anemia. Women with higher vitamin D status had a 42 percent lower risk of mortality from any cause.

Vitamin D is necessary for calcium absorption in the intestines, which subsequently supports bone growth and prevents osteoporosis in adults. In addition, vitamin D regulates the immune system and certain genes responsible for cell differentiation, proliferation, and apoptosis (cell death).

Vitamin D, which is present in some foods, is also produced by the human body when individuals are exposed to sunlight. It can also be taken in the form of dietary supplement pills for those who are not obtaining enough through these natural means.

If the human body is not producing vitamin D due to lack of exposure to sunlight, the recommended dosage for men and women from 14 to 50 years of age is 5 micrograms per day. For older individuals, higher amounts of vitamin D are recommended.

The results of this study are significant for HIV patients, as further studies on the effects of vitamin D on HIV disease progression could lead to vitamin D becoming recognized as an accessible and economical way of prolonging the initiation of antiretroviral therapy.

For more information please see the PLoS One Web site.