A Trial of Vitamins and HAART in HIV Disease Progression

HIV Infections Clinical Trial

Official title:

Trial of Vitamins in HIV Progression and Transmission (A Trial of Vitamins and HAART in HIV Disease Progression)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00383669
• Other study ID #: HD32257-01
• Secondary ID: P12981-101
• Status: Completed
• Phase: Phase 3
• Start date: November 2006
• Est. completion date: October 2009

Study information

• Verified date: July 2020
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4012
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease Progression
• HIV Infections

Intervention

Dietary Supplement:
• Multivitamins (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).
• Multivitamins 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).

Locations

Country	Name	City	State
Tanzania	Muhimbili University College of Health Sciences	Dar es Salaam

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

Tanzania, 

Outcome

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