HIV InfectionsNCT00149656
The Effects of Nutritional Supplementation and Drug Abuse on HIV
A study testing Multivitamins and Selenium in people with HIV Infections and Substance-Related Disorders, run by Florida International University at 1 site in Botswana.
Trial summary
The purpose of this trial is to determine whether supplementation with multivitamins and selenium will delay disease progression in HIV infected individuals in Botswana. The study will also assess how drug abuse modifies the effect of nutritional supplementation on HIV disease progression. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- HIV Infections, Substance-Related Disorders
- What is being tested?
- Multivitamins and Selenium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 878 participants
- Where
- 1 siteBotswana
- Study dates
- Jun 2003to Apr 2013
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infected
- CD4 count greater than 350 cells/mm3
- Identified from the Infectious Disease Care Clinic
- Body mass index greater than 18 for women and greater than 18.5 for men
Who cannot join
- Current AIDS-defining condition
- Currently participating in another clinical trial
- Pregnant or intends to become pregnant during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HIV Disease, Drug Abuse, and Nutrient Therapy in Botswana
The purpose of this trial is to determine whether supplementation with multivitamins and selenium will delay disease progression in HIV infected individuals in Botswana. The study will also assess how drug abuse modifies the effect of nutritional supplementation on HIV disease progression.
Read the detailed description
Botswana has the highest rates of HIV infection in the world. In addition, drug abuse has become an emerging problem in Botswana. Past research suggests that multivitamin and selenium supplementation slows the progression of HIV disease. The purpose of this trial is to evaluate the effectiveness of supplementation with multivitamins and selenium in HIV infected individuals in Botswana.
This trial will last 2 years. Participants will be randomly assigned to 4 groups: a combination of multivitamins with selenium, multivitamins alone, selenium alone, or placebo.
- Conditions
- HIV Infections, Substance-Related Disorders
- Being tested
- Multivitamins, Selenium, Placebo
- Keywords
- Treatment Naive, Multivitamins, Selenium, Supplementation, HIV Disease Progression
- Medical subject headings
- HIV Infections, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MultivitaminsDietary supplement
dietary supplement of multivitamins
SeleniumDietary supplement
dietary supplement of selenium only
PlaceboOther
placebo pill
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Other: Placebo |
| 2 | Experimental | Multivitamins Receives: Dietary Supplement: Multivitamins |
| 3 | Experimental | Multivitamins with Selenium Receives: Dietary Supplement: Multivitamins; Dietary Supplement: Selenium |
| 4 | Experimental | Selenium Receives: Dietary Supplement: Selenium |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Disease Progression
Measured: For at least 6 months
Secondary outcomes (1)
Morbidity
Measured: For at least 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startJun 2003
- Primary completionJul 2010
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 878 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Marianna K. Baum, PhD, Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149656
- Sponsor's protocol ID
- NIDA-16551-1
- Other IDs
- R01DA016551, R01-16551-1, DPMC
- Status last verified
- Apr 2013
- First submitted
- 6 Sep 2005
- Last updated
- 29 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Disease, Drug Abuse, and Nutrient Therapy in Botswana
- ClinicalTrials.gov ID
- NCT00149656
- Acronym / sponsor ID
- NIDA-16551-1
- Conditions
- HIV Infections, Substance-Related Disorders
- Keywords
- Treatment Naive, Multivitamins, Selenium, Supplementation, HIV Disease Progression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 878 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2003
- Primary completion
- Jul 2010 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 8 Sep 2005 (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.
The purpose of this trial is to determine whether supplementation with multivitamins and selenium will delay disease progression in HIV infected individuals in Botswana. The study will also assess how drug abuse modifies the effect of nutritional supplementation on HIV disease progression.
Detailed description
Botswana has the highest rates of HIV infection in the world. In addition, drug abuse has become an emerging problem in Botswana. Past research suggests that multivitamin and selenium supplementation slows the progression of HIV disease. The purpose of this trial is to evaluate the effectiveness of supplementation with multivitamins and selenium in HIV infected individuals in Botswana.
This trial will last 2 years. Participants will be randomly assigned to 4 groups: a combination of multivitamins with selenium, multivitamins alone, selenium alone, or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Other: Placebo |
| 2 | Experimental | Dietary Supplement: MultivitaminsMultivitamins |
| 3 | Experimental | Dietary Supplement: Multivitamins, Dietary Supplement: SeleniumMultivitamins with Selenium |
| 4 | Experimental | Dietary Supplement: SeleniumSelenium |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV infected
- CD4 count greater than 350 cells/mm3
- Identified from the Infectious Disease Care Clinic
- Body mass index greater than 18 for women and greater than 18.5 for men
Key exclusion criteria (3 listed)
- Current AIDS-defining condition
- Currently participating in another clinical trial
- Pregnant or intends to become pregnant during the study
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 |
|---|---|---|
| Multivitaminsdietary supplement of multivitamins | Dietary supplement | 2, 3 |
| Seleniumdietary supplement of selenium only | Dietary supplement | 3, 4 |
| Placeboplacebo pill | Other | 1 |
Primary outcome
HIV Disease Progression
Time frame: For at least 6 months
1 secondary outcome
Morbidity
Time frame: For at least 6 months
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 29 Apr 2013.
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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.
Marianna K. Baum, PhD principal investigator
Florida International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multivitamins and Selenium in people with HIV Infections and Substance-Related Disorders, run by Florida International University at 1 site in Botswana.
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 29 Apr 2013. 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 Botswana. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
HIV Disease Progression (time frame: For at least 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2013.