A Trial of Vitamins and HAART in HIV Disease Progression

Conditions

HIV Infections

Keywords

HIV, AIDS, Disease Progression, Multivitamins, Anti-Retroviral Therapy, HAART, Tanzania, Africa

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.

Ajibola Ibraheem Abioye, Michael D. Hughes, Christopher R. Sudfeld, Ramadhani Noor, Sheila Isanaka et al. (8 authors)

JAIDS Journal of Acquired Immune Deficiency Syndromes2023-05-18

10.1097/qai.0000000000003221

Impaired Hematological Status Increases the Risk of Mortality among HIV-Infected Adults Initiating Antiretroviral Therapy in Tanzania.

Noor RA, Abioye AI, Hertzmark E, Darling AM, Aboud S, Mugusi FM, Sudfeld CR, Spiegelman D, Fawzi WW.

2020-09-018 citations

10.1093/jn/nxaa172

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.

Sudfeld CR, Isanaka S, Mugusi FM, Aboud S, Wang M, Chalamilla GE, Giovannucci EL, Fawzi WW.

2013-05-0128 citations

10.3945/ajcn.112.053728

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.

Isanaka S, Mugusi F, Hawkins C, Spiegelman D, Okuma J, Aboud S, Guerino C, Fawzi WW.

2012-10-0136 citations

10.1001/jama.2012.13083

Interventions

DIETARY_SUPPLEMENTMultivitamins (including B, C and E)

One daily oral dose of 20 mg B1, 20 mg B2, 25 mg B6, 100 mg niacin, 50 μg B12, 0.8 mg folic acid, 500 mg C, and 30 mg vitamin E taken taken from randomization until the end of follow-up (24-28 months).

DIETARY_SUPPLEMENTMultivitamins B, C and E

One daily oral dose of 1.2 mg vitamin B1, 1.2 mg vitamin B2, 1.3 mg vitamin B6, 15 mg niacin, 2.4 μg vitamin B12, 0.4 mg folic acid, 80 mg vitamin C, and 15 mg vitamin E taken taken from randomization until the end of follow-up (24-28 months).

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Development of a new or recurrent disease progression event, including all-cause death.	within 24 months after randomization

Secondary

Measure	Time frame
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	within 24 months of randomization

Countries

Tanzania

Outcome results

None listed