The HIV Micronutrient Study:
Study Protocol

Broad-Spectrum Micronutrient Supplementation in Patients Who Develop Peripheral Neuropathy While Taking Stavudine or Didanosine Antiviral Therapy

The results of the HIV Micronutrient Study were presented at the 11th Conference on Retroviruses and Opportunistic Infections held in San Francisco this February 2004. The results showed that the patients who took a high-dose micronutrient formula (Dr. Jon Kaiser's Immune Support Formula) experienced an average increase of 26% in their CD4 counts during a 12 week period. The increase in CD4 count was statistically significant in both the on-treatment and intent-to-treat analysis.

What follows below is a summary of the study protocol.

This research was funded in part by a generous grant from the Bristol-Myers Squibb Company. It is the first study to look at broad spectrum micronutrient supplementation as an adjunct to standard medical therapy for HIV-infected individuals.

Study Protocal Synopsis

Objective: To determine if broad-spectrum, micronutrient supplementation is an effective, non-toxic treatment for medication-induced peripheral neuropathy in HIV-infected patients.

Design: A randomized, double-blind, placebo-controlled, clinical trial to study the use of high-dose broad-spectrum micronutrient supplementation vs. placebo for the treatment of stavudine and/or didanosine-induced peripheral neuropathy in patients with HIV infection.

Statistics: A 1:1 patient ratio, randomized to high-dose vs. placebo arms, is to be analyzed.

Sample Size: A total of 60 patients are to be enrolled.

Study Population: Sixty HIV-infected patients who meet the following criteria will be admitted to the study.

Inclusion Criteria:

  1. HIV infection. This diagnosis can be based on the medical history, clinical signs and symptoms, or results of laboratory testing.
  2. CD4 cells greater or equal to 100 cells/mm3.
  3. Acute onset of lower extremity peripheral neuropathy, based on history and physical exam, during the past twelve months.
  4. Currently taking antiviral therapy with stavudine (D4T) and/or didanosine (DDI), appropriately dosed based upon weight.
  5. At least 18 years of age.
  6. Women of child bearing potential must have a negative pregnancy test within two weeks prior to randomization and agree to practice barrier method birth control during the study period.
  7. Willingness and ability to sign an informed consent statement and to comply with the protocol.

Exclusion Criteria:

  1. Known allergy or intolerance to any nutrient supplements contained in the treatment arm.
  2. Pregnancy.
  3. Active treatment for an acute opportunistic infection or malignancy, except for non-systemic treatment of Kaposi's Sarcoma.
  4. Symptoms of lower extremity peripheral neuropathy that have been present for greater than twelve months.
  5. CD4 cell count < 100 cells/mm3.
  6. Vitamin B12 deficiency.
  7. ALT greater than 10X normal range.
  8. Serum creatinine greater or equal to 2.0 mg/dL.
  9. Therapy with recombinant human growth hormone during the past week and/or during the study period. Patients on prior therapy can participate in the study providing they "wash out" during the period between the screening and baseline visits.
  10. Any pharmacologic treatment for peripheral neuropathy during the past week ("wash out" for one week prior to baseline visit is required). This includes both prescription and non-prescription- strength non-steroidal anti-inflammatory drugs (NSAIDS), narcotic and non-narcotic analgesics, tricyclic antidepressants, and anticonvulsant medications such as gabapentin (Neurontin).
  11. Acupuncture and/or massage therapy, specifically to treat peripheral neuropathy symptoms, during the past four weeks.
  12. Currently taking micronutrient or herbal supplements greater than one multivitamin pill per day.

Study Intervention: Patients in both arms of the study will consume one nutrient packet twice daily at the beginning of a meal.

Each micronutrient packet will include the following nutrients:

1) Multivitamin - high potency
2) Multimineral -high potency
3) Vitamin B6 100 mg
4) Acetyl L-carnitine 500 mg
5) Alpha-lipoic acid 200 mg
6) N-acetyl cysteine 600 mg

Each placebo nutrient packet will include an identical appearing packet of placebo capsules.

Efficacy Evaluations:

  1. Changes in pain intensity at 4, 8, and 12 weeks of treatment will be assessed by the Neuropathy Inventory Linear Analog Scale (NILAS).
  2. Changes in quality of life at 4, 8, and 12 weeks of treatment will be assessed by the Linear Analog Scale Assessment (LASA) and the Medical Outcomes HIV Health Survey (MOS-HIV).
  3. Changes in the neurological examination at 4, 8, and 12 weeks of treatment will be assessed by the Neurologic Examination Assessment Tool (NEAT).
  4. The percentage of patients in each group able to continue their original antiviral medications at 4, 8, and 12 weeks of treatment will be assessed.
  5. The percentage of patients in each group able to avoid taking prescription strength pain medications at 4, 8, and 12 weeks of treatment will be assessed.
  6. Any changes in metabolic and immunologic measurements (including CD4 cells, HIV RNA, fasting plasma lactate, fasting lipid panel. fasting insulin level, fasting glucose level, and liver function tests in each group will be measured at 4, 8, and 12 weeks of treatment.

Safety Evaluations: Assessment of laboratory tests, vital signs, as well as incidence and severity of adverse experiences will be closely monitored by study personnel.

 

 

  

Search E-newsletter and Answers from Dr. Kaiser archives:

Our Approach

Micronutrient Research Project

BulletStudy Summary

CD4 count increase graph

Background Information

Wisdom from the 12th CROI

Wisdom from the 11th CROI

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