Overview

This trial is active, not recruiting.

Condition hiv infection
Treatments micronutrients and antioxidants, multivitamins and minerals
Phase phase 2/phase 3
Sponsor Ottawa Hospital Research Institute
Collaborator CIHR Canadian HIV Trials Network
Start date January 2009
End date May 2014
Trial size 218 participants
Trial identifier NCT00798772, CTN 238

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
micronutrients and antioxidants K-PAX Ultra
8 capsules twice daily for two years
(Active Comparator)
multivitamins and minerals Centrum-like multivitamins and minerals
8 capsules twice daily for two years

Primary Outcomes

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

Secondary Outcomes

Measure
Non-AIDS related adverse events
time frame: Quarterly
Tolerance of and adherence to study medication
time frame: Quarterly
Time from baseline to CD4+ cell count <350 cells/mm3 (confirmed by two measures at least one week apart)
time frame: Quarterly
Time from baseline to emergence of documented CDC-defined AIDS-defining illness
time frame: Quarterly
Time from baseline to start of ART
time frame: Quarterly
Serial quarterly lymphocyte measures (ALC, CD4+, CD8+, and CD3+ cell counts, CD4%, CD8%, CD4:CD8)
time frame: Quarterly
Serial quarterly HIV RNA plasma viral load
time frame: Quarterly
Serum chemistries: Glucose, BUN, creatinine, total protein, albumin, alkaline phosphatase, ALT, AST, total bilirubin,
time frame: Quarterly
Serum micronutrient levels: carotene (quarterly), vitamin B12 (quarterly), folate (six monthly) and vitamin D (25-OHD six monthly)
time frame: Quarterly or as specified
Quality of Life measures
time frame: Quarterly

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

Official title A Randomized Control Clinical Trial Of Micronutrient & Antioxidant Supplementation in Persons With Untreated HIV Infection
Principal investigator William Cameron, MD, FRCPC
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Ottawa Hospital Research Institute.