A Trial of Vitamins and HAART in HIV Disease Progression

NCT00383669 | Completed Phase 3 DMC

• 2 other identifiers: HD32257-01P12981-101
• Study Type: interventional
• Target: 4,012
• Locations: 1 country
• Sites: 1

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).

Conditions

HIV Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Development of a new or recurrent disease progression event, including all-cause death.

  within 24 months after randomization

Secondary Outcomes (1)

• 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

Study Arms (2)

Multiple RDA multivitamins

ACTIVE COMPARATOR

Multivitamins (including B, C, and E)

Dietary Supplement: Multivitamins (including B, C and E)

Single RDA Multivitamins

ACTIVE COMPARATOR

Multivitamins (including B, C, and E)

Dietary Supplement: Multivitamins B, C and E

Interventions

Multivitamins (including B, C and E) DIETARY_SUPPLEMENT

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).

Multiple RDA multivitamins

Multivitamins B, C and E DIETARY_SUPPLEMENT

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).

Single RDA Multivitamins

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Muhimbili University College of Health Sciences

Dar es Salaam, Tanzania

Location

Related Publications (5)

• Abioye AI, Hughes MD, Sudfeld CR, Noor RA, Isanaka S, Lukmanji Z, Mugusi F, Fawzi WW. Dietary Iron Intake and HIV-Related Outcomes Among Adults Initiating Antiretroviral Therapy in Tanzania. J Acquir Immune Defic Syndr. 2023 Sep 1;94(1):57-65. doi: 10.1097/QAI.0000000000003221.

  PMID: 37199401 DERIVED

• 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.

  PMID: 32621487 DERIVED

• 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.

  PMID: 25562355 DERIVED

• 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.

  PMID: 23636235 DERIVED

• 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.

  PMID: 23073950 DERIVED

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; Disease Progression

Interventions

Geritol

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wafaie W Fawzi, MD,DrPH

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Global Health and Population

Study Record Dates

• First Submitted: September 29, 2006
• First Posted: October 3, 2006
• Study Start: November 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: July 16, 2020

Record last verified: 2020-07

Locations

TA (1)