Micronutrients and Antioxidants in HIV Infection (MAINTAIN)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
CIHR Canadian HIV Trials Network
Ontario HIV Treatment Network
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00798772
First received: November 25, 2008
Last updated: June 20, 2014
Last verified: June 2014

November 25, 2008
June 20, 2014
January 2009
September 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00798772 on ClinicalTrials.gov Archive Site
  • 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: Yes ]
  • 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: Glucose, BUN, creatinine, total protein, albumin, alkaline phosphatase, ALT, AST, total bilirubin, [ Time Frame: Quarterly ] [ Designated as safety issue: Yes ]
  • Serum micronutrient levels: carotene (quarterly), vitamin B12 (quarterly), folate (six monthly) and vitamin D (25-OHD six monthly) [ Time Frame: Quarterly or as specified ] [ Designated as safety issue: No ]
  • Quality of Life measures [ Time Frame: Quarterly ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Micronutrients and Antioxidants in HIV Infection
A Randomized Control Clinical Trial Of Micronutrient & Antioxidant Supplementation in Persons With Untreated HIV Infection

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.

Background: Antiretroviral therapy (ART) has improved the prognosis of persons with human immunodeficiency virus (HIV) infection, but is expensive and potentially toxic. Micronutrient deficiencies occur even in early stages of HIV infection and increase risk of morbidity, disease progression to acquired immunodeficiency syndrome (AIDS) and mortality, but the role of micronutrient antioxidant supplements in medical management of HIV/AIDS is not clear.

Objective: To determine if supplementation of untreated asymptomatic HIV-infected persons with a broad-spectrum micronutrient and antioxidant preparation will reduce the rate of decline of CD4 T lymphocyte count, or delay emergence of documented CDC-defined AIDS-defining illness, or start of ART compared to 100% recommended daily allowance (RDA) multivitamins and minerals, and is safe.

Study design: A prospective, randomized, controlled, double blind clinical trial of supplementation of 218 untreated asymptomatic HIV-infected adults with a micronutrient and antioxidant preparation or identical appearing RDA multivitamins and minerals for two years, with quarterly follow up in clinic for assessment of time from baseline to CD4 count <350 mm3, or emergence of documented CDC-defined AIDS-defining illness, or start of ART.

Participants and sample size: 218 participants from clinics in Ontario and other participating centres of the CIHR Canadian HIV Trials Network (CTN).

Study duration: approximately five years, allowing for approximately three years for participant accrual and two years follow-up.

Eligibility criteria: The main eligibility criteria are:

• Asymptomatic HIV-infected adults at least 18 years of age

• CD4+ cells ≥375 and ≤750 cells/mm3

• No previous ART (excluding less than seven days and perinatal transmission prophylaxis) Study intervention: Oral supplementation with a broad spectrum micronutrient and antioxidant preparation (n=109) or identical appearing RDA multivitamins and minerals (n=109).

Primary outcome: 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

Secondary outcomes:

• Non-AIDS related adverse events

• Tolerance of and adherence to study medication

• Time from baseline to CD4+ cell count <350 cells/mm3 (confirmed by two measures at least one week apart)

• Time from baseline to emergence of documented CDC-defined AIDS-defining illness

• Time from baseline to start of ART

• Serial quarterly lymphocyte measures: absolute lymphocyte count (ALC), CD4+, CD8+, and CD3+ cell counts, CD4%, CD8%, CD4:CD8

• Serial quarterly HIV RNA plasma viral load

• Serum chemistries: Glucose, BUN, creatinine, total protein, C-reactive protein, albumin, alkaline phosphatase, ALT, AST, total bilirubin

• Serum micronutrient levels: Carotene (quarterly) and vitamin B12 (quarterly), folate (six monthly) and vitamin D (25-OHD, six monthly)

• Quality of Life measures: MOS HIV, EuroQol, and Health Utilities Index (HUI) Statistical analysis: Analysis of the primary outcome by intention-to-treat will compare time from baseline to primary outcome. Interim analyses are planned once 100 participants are followed for one year.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Infection
  • Dietary Supplement: Micronutrients and antioxidants
    8 capsules twice daily for two years
    Other Name: K-PAX Ultra
  • Dietary Supplement: Multivitamins and minerals
    8 capsules twice daily for two years
    Other Name: Centrum-like multivitamins and minerals
  • Experimental: A: Broad spectrum micronutrients
    Intervention: Dietary Supplement: Micronutrients and antioxidants
  • Active Comparator: B: Identical appearing multivitamins
    Intervention: Dietary Supplement: Multivitamins and minerals

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
218
September 2015
September 2014   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00798772
CTN 238
Yes
Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
  • CIHR Canadian HIV Trials Network
  • Ontario HIV Treatment Network
Principal Investigator: William Cameron, MD, FRCPC University of Ottawa at The Ottawa Hospital
Ottawa Hospital Research Institute
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP