Trial record 12 of 33 for:
" November 01, 2008":" December 01, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
Micronutrients and Antioxidants in HIV Infection (MAINTAIN)
This study is currently recruiting participants.
Verified May 2013 by Ottawa Hospital Research Institute
Sponsor:
Ottawa Hospital Research Institute
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: May 9, 2013
Last verified: May 2013
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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 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized Control Clinical Trial Of Micronutrient & Antioxidant Supplementation in Persons With Untreated HIV Infection |
Resource links provided by NLM:
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: 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 ]
| Estimated Enrollment: | 218 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A: Broad spectrum micronutrients |
Dietary Supplement: Micronutrients and antioxidants
8 capsules twice daily for two years
Other Name: K-PAX Ultra
|
| Active Comparator: B: Identical appearing multivitamins |
Dietary Supplement: Multivitamins and minerals
8 capsules twice daily for two years
Other Name: Centrum-like multivitamins and minerals
|
Show Detailed Description 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 |
| Contact: Nancy Lamoureux, RN | 613-737-8209 | nlamoureux@ohri.ca |
Locations
| Canada, Ontario | |
| The Ottawa Hospital, General Campus | Recruiting |
| Ottawa, Ontario, Canada, K1H 8L6 | |
Sponsors and Collaborators
Ottawa Hospital Research Institute
CIHR Canadian HIV Trials Network
Ontario HIV Treatment Network
Investigators
| Principal Investigator: | William Cameron, MD, FRCPC | University of Ottawa at The Ottawa Hospital |
More Information
Publications:
| Responsible Party: | Ottawa Hospital Research Institute |
| ClinicalTrials.gov Identifier: | NCT00798772 History of Changes |
| Other Study ID Numbers: | CTN 238 |
| Study First Received: | November 25, 2008 |
| Last Updated: | May 9, 2013 |
| Health Authority: | Canada: Ethics Review Committee Canada: Health Canada |
Keywords provided by Ottawa Hospital Research Institute:
|
HIV infection Micronutrients Antioxidants |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Antioxidants Micronutrients Trace Elements Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Growth Substances |
ClinicalTrials.gov processed this record on May 16, 2013