Micronutrients and Antioxidants in HIV Infection - Full Text View

Sponsored by:	Ottawa Hospital Research Institute
Information provided by:	Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:	NCT00798772

Purpose

Infection with human immunodeficiency virus (HIV) causes decline in immunity or the ability to fight infection and progresses to acquired immunodeficiency disease (AIDS). Anti-HIV drug treatment has improved the prognosis of persons with HIV infection, but is expensive and potentially toxic. Low micronutrient levels occur in the blood even in early stages of HIV infection and increase risk of a poorer prognosis, but the role of micronutrient and antioxidant supplements in medical management of HIV/AIDS is not well defined. The proposed clinical trial aims to assess if supplementation of untreated HIV-infected adults with a micronutrient and antioxidant preparation can delay decline in immunity or disease progression or start of anti-HIV drug treatment compared with supplementation with standard multivitamins. If the findings are positive, the study has implications for health and health care savings.

Condition	Intervention	Phase
HIV Infection	Dietary Supplement: Micronutrients and antioxidants Dietary Supplement: Multivitamins and minerals	Phase II Phase III

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Control Clinical Trial Of Micronutrient & Antioxidant Supplementation in Persons With Untreated HIV Infection

Resource links provided by NLM:

MedlinePlus related topics: AIDS Antioxidants Dietary Supplements Diets Minerals

U.S. FDA Resources

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:

Time from baseline to CD4+ cell count <350 cells/mm3 (confirmed by two measures at least one week apart), or emergence of documented CDC-defined AIDS-defining illness, or start of ART [ Time Frame: Quarterly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Non-AIDS related adverse events [ Time Frame: Quarterly ] [ Designated as safety issue: Yes ]
Tolerance of and adherence to study medication [ Time Frame: Quarterly ] [ Designated as safety issue: No ]
Time from baseline to CD4+ cell count <350 cells/mm3 (confirmed by two measures at least one week apart) [ Time Frame: Quarterly ] [ Designated as safety issue: No ]
Time from baseline to emergence of documented CDC-defined AIDS-defining illness [ Time Frame: Quarterly ] [ Designated as safety issue: No ]
Time from baseline to start of ART [ Time Frame: Quarterly ] [ Designated as safety issue: No ]
Serial quarterly lymphocyte measures (ALC, CD4+, CD8+, and CD3+ cell counts, CD4%, CD8%, CD4:CD8) [ Time Frame: Quarterly ] [ Designated as safety issue: No ]
Serial quarterly HIV RNA plasma viral load [ Time Frame: Quarterly ] [ Designated as safety issue: No ]
Serum chemistries: Fasting glucose, BUN, creatinine, total protein, albumin, alkaline phosphatase, lactate, ALT, AST, amylase, lipase, total bilirubin, [ Time Frame: Quarterly ] [ Designated as safety issue: Yes ]
Serum micronutrient levels: carotene, vitamin B12 , folate (six monthly) and vitamin D (25-OHD annually) [ Time Frame: Quarterly or as specified ] [ Designated as safety issue: No ]
Quality of Life measures [ Time Frame: Quarterly ] [ Designated as safety issue: No ]

Estimated Enrollment:	218
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Broad spectrum micronutrients: Experimental	Dietary Supplement: Micronutrients and antioxidants 8 capsules twice daily for two years
B: Identical appearing multivitamins: Active Comparator	Dietary Supplement: Multivitamins and minerals 8 capsules twice daily for two years

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

be an asymptomatic HIV infected adult
at least 18 years of age
have CD4+ cells between 375 and 750 cells/mm3
have received no ART (excluding less than seven days and perinatal transmission prophylaxis)
if a woman of child bearing potential, have a negative pregnancy test within two weeks prior to randomization and agree to practice barrier method of birth control during the study
be willing and able to sign informed consent and to comply with the study protocol

Exclusion Criteria:

have HIV-2 infection alone
have known allergy or intolerance to any study medication ingredient
be pregnant
have active treatment for an acute opportunistic infection or malignancy
have ALT greater than 3 x normal range
have known cirrhosis of the liver
have serum creatinine less than 133 umol/L
abuse alcohol and recreational drugs
be taking micronutrient (except vitamin D*) or natural health product supplements within 30 days of randomization
- Maximum 2000 IU daily (Health Canada Guidelines).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798772

Contacts

Contact: William Cameron, MD

613-737-8923

bcameron@ohri.ca

Locations

Canada, Ontario
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada, K1H 8L6

Sponsors and Collaborators

Ottawa Hospital Research Institute

Investigators

Principal Investigator:

William Cameron, MD, FRCPC

University of Ottawa at The Ottawa Hospital

More Information

Publications:

Austin J, Singhal N, Voigt R, Smaill F, Gill MJ, Walmsley S, Salit I, Gilmour J, Schlech WF 3rd, Choudhri S, Rachlis A, Cohen J, Trottier S, Toma E, Phillips P, Ford PM, Woods R, Singer J, Zarowny DP, Cameron DW; CTN 091/CRIT Cartenoids Study Group. A community randomized controlled clinical trial of mixed carotenoids and micronutrient supplementation of patients with acquired immunodeficiency syndrome. Eur J Clin Nutr. 2006 Nov;60(11):1266-76. Epub 2006 May 24.

Kaiser JD, Campa AM, Ondercin JP, Leoung GS, Pless RF, Baum MK. Micronutrient supplementation increases CD4 count in HIV-infected individuals on highly active antiretroviral therapy: a prospective, double-blinded, placebo-controlled trial. J Acquir Immune Defic Syndr. 2006 Aug 15;42(5):523-8.

Responsible Party:	Ottawa Health Research Institute ( Dr. D. William Cameron )
Study ID Numbers:	CTNS 238
Study First Received:	November 25, 2008
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00798772 History of Changes
Health Authority:	Canada: Ethics Review Committee; Canada: Health Canada

Keywords provided by Ottawa Hospital Research Institute:

HIV infection
Micronutrients
Antioxidants

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Antioxidants
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Trace Elements
Micronutrients
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Antioxidants
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Growth Substances
Physiological Effects of Drugs
Acquired Immunodeficiency Syndrome
Trace Elements

Infection
Protective Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Micronutrients
Retroviridae Infections

ClinicalTrials.gov processed this record on September 10, 2009