HIV InfectionsPhase 3NCT00383669

A Trial of Vitamins and HAART in HIV Disease Progression

A Phase 3 study testing Multivitamins (including B, C and E) and Multivitamins B, C and E in people with HIV Infections, run by Harvard School of Public Health (HSPH) at 1 site in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections
What is being tested?: Multivitamins (including B, C and E) and Multivitamins B, C and E
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4,012 participants
Where: 1 siteTanzania
Study dates: Nov 2006to Oct 2009
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Tanzania1 site

Muhimbili University College of Health Sciences
Dar es Salaam

Other trials in Tanzania

About this study

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

Read the 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".

Conditions: HIV Infections
Being tested: Multivitamins (including B, C and E), Multivitamins B, C and E
Keywords: HIV, AIDS, Disease Progression, Multivitamins, Anti-Retroviral Therapy, HAART, Tanzania, Africa
Medical subject headings: HIV Infections, Acquired Immunodeficiency Syndrome, Disease Progression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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).
Multivitamins B, C and EDietary 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).

Study groups in NCT00383669
Study group	Role	What they receive
Multiple RDA multivitamins	Active comparator	Multivitamins (including B, C, and E) Receives: Dietary Supplement: Multivitamins (including B, C and E)
Single RDA Multivitamins	Active comparator	Multivitamins (including B, C, and E) Receives: Dietary Supplement: Multivitamins B, C and E

What is being measured

The primary outcome is the main question the study is designed to answer.

Development of a new or recurrent disease progression event, including all-cause death.
Measured: 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
Measured: within 24 months of randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2006Oct 2009

First posted3 Oct 2006 (estimated)
Study startNov 2006
Primary completionOct 2009
Study completionOct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 4,012 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00383669
Sponsor's protocol ID: HD32257-01
Other IDs: P12981-101
Status last verified: Jul 2020
First submitted: 29 Sep 2006
Last updated: 16 Jul 2020
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 37199401
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.
PubMed 32621487
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.
PubMed 25562355
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.
PubMed 23636235
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.
PubMed 23073950

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Trial of Vitamins in HIV Progression and Transmission (A Trial of Vitamins and HAART in HIV Disease Progression)
ClinicalTrials.gov ID: NCT00383669
Acronym / sponsor ID: HD32257-01
Conditions: HIV Infections
Keywords: HIV, AIDS, Disease Progression, Multivitamins, Anti-Retroviral Therapy, HAART, Tanzania, Africa
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 4,012 participants (actual)
Lead sponsor: Harvard School of Public Health (HSPH)University, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: Nov 2006
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 3 Oct 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Multiple RDA multivitamins	Active comparator	Dietary Supplement: Multivitamins (including B, C and E)Multivitamins (including B, C, and E)
Single RDA Multivitamins	Active comparator	Dietary Supplement: Multivitamins B, C and EMultivitamins (including B, C, and E)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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).	Dietary supplement	Multiple RDA multivitamins
Multivitamins B, C and EOne 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).	Dietary supplement	Single RDA Multivitamins

Primary outcome

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

1 secondary outcome

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
Time frame: within 24 months of randomization

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
Derived from this study: PubMed 37199401Abioye 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.
Derived from this study: PubMed 32621487Noor 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.
Derived from this study: PubMed 25562355Abioye 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.
Derived from this study: PubMed 23636235Sudfeld 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.
Derived from this study: PubMed 23073950Isanaka 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.

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NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wafaie W Fawzi, MD,DrPH principal investigator

Harvard School of Public Health (HSPH)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Multivitamins (including B, C and E) and Multivitamins B, C and E in people with HIV Infections, run by Harvard School of Public Health (HSPH) at 1 site in Tanzania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Development of a new or recurrent disease progression event, including all-cause death. (time frame: within 24 months after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00383669, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.