Clinical trial NCT00383669: A Trial of Vitamins and HAART in HIV Disease Progression
Official title: Trial of Vitamins in HIV Progression and Transmission (A Trial of Vitamins and HAART in HIV Disease Progression)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV
AIDS
Disease Progression
Multivitamins
Anti-Retroviral Therapy
HAART
Tanzania
Africa
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2006-10-03
Enrollment: 4012
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This study is a double-blind randomized clinical trial, conducted to examine the effects of multivitamins (including B, C, and E) on HIV disease progression among HIV-positive Tanzanian adult men and women taking highly active anti-retroviral therapy (HAART).

Detailed description: Access to Highly Active Anti-Retroviral Therapy (HAART) for the treatment of HIV in developing regions is limited, but gradually becoming standard of care in some countries. Multivitamin supplements have demonstrated immune-enhancing effects among individuals in pre-HAART HIV disease stages. However, the efficacy and safety of micronutrient supplements need to be documented in the context of HAART. This study is a double-blind randomized clinical trial, conducted to examine the effect of multivitamins (including B, C, and E) on HIV disease progression among individuals taking HAART. Participants are HIV-positive Tanzanian men and women aged 18 years and older, who are initiating HAART at the time of randomization. Eligible individuals are randomized to receive daily oral supplements in one of two intervention groups: a) multivitamins at the single Recommended Dietary Allowance (RDA) level; and b) multivitamins at multiples of the RDA at the same doses used in our previous study "A Trial of Vitamins in HIV Progression and Transmission".

Eligibility criteria: Inclusion Criteria:

* HIV-positive
* Men or Women
* 18 Years of Age or older
* Initiating HAART at time of randomization

Exclusion Criteria:

* Pregnant or Lactating Women
* Individuals at pre-HAART disease stages
* BMI less than 16

Primary outcomes:
measure: Development of a new or recurrent disease progression event, including all-cause death.
timeFrame: within 24 months after randomization
Secondary outcomes:
measure: Changes in: (a) CD4 cell count, (b) plasma HIV-1 RNA concentration, (c) weight, and (d) alteration to second-line anti-retroviral treatment; and occurrence of (a) adverse events, specifically peripheral neuropathy
timeFrame: within 24 months of randomization
Other outcomes:
Locations:
city: Dar es Salaam
country: Tanzania
facility: Muhimbili University College of Health Sciences
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Wafaie W Fawzi, MD,DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Noor RA, Abioye AI, Hertzmark E, Darling AM, Aboud S, Mugusi FM, Sudfeld CR, Spiegelman D, Fawzi WW. Impaired Hematological Status Increases the Risk of Mortality among HIV-Infected Adults Initiating Antiretroviral Therapy in Tanzania. J Nutr. 2020 Sep 1;150(9):2375-2382. doi: 10.1093/jn/nxaa172.
citation: Abioye AI, Isanaka S, Liu E, Mwiru RS, Noor RA, Spiegelman D, Mugusi F, Fawzi W. Gender differences in diet and nutrition among adults initiating antiretroviral therapy in Dar es Salaam, Tanzania. AIDS Care. 2015;27(6):706-15. doi: 10.1080/09540121.2014.996517. Epub 2015 Jan 6.
citation: Sudfeld CR, Isanaka S, Mugusi FM, Aboud S, Wang M, Chalamilla GE, Giovannucci EL, Fawzi WW. Weight change at 1 mo of antiretroviral therapy and its association with subsequent mortality, morbidity, and CD4 T cell reconstitution in a Tanzanian HIV-infected adult cohort. Am J Clin Nutr. 2013 Jun;97(6):1278-87. doi: 10.3945/ajcn.112.053728. Epub 2013 May 1.
citation: Isanaka S, Mugusi F, Hawkins C, Spiegelman D, Okuma J, Aboud S, Guerino C, Fawzi WW. Effect of high-dose vs standard-dose multivitamin supplementation at the initiation of HAART on HIV disease progression and mortality in Tanzania: a randomized controlled trial. JAMA. 2012 Oct 17;308(15):1535-44. doi: 10.1001/jama.2012.13083.