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The Effects of Nutritional Supplementation and Drug Abuse on HIV

Primary Purpose

HIV Infections, Substance-Related Disorders

Status

Completed

Phase

Not Applicable

Locations

Botswana

Study Type

Interventional

Intervention

Multivitamins

Selenium

Placebo

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Treatment Naive, Multivitamins, Selenium, Supplementation, HIV Disease Progression

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: Current AIDS-defining condition Currently participating in another clinical trial Pregnant or intends to become pregnant during the study

Sites / Locations

Princess Marina Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm Description

Multivitamins

Multivitamins with Selenium

Selenium

Outcomes

Primary Outcome Measures

HIV Disease Progression

Secondary Outcome Measures

Morbidity

Full Information

NCT ID

NCT00149656

First Posted

September 6, 2005

Last Updated

April 26, 2013

Sponsor

Florida International University

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT00149656

Brief Title

The Effects of Nutritional Supplementation and Drug Abuse on HIV

Official Title

HIV Disease, Drug Abuse, and Nutrient Therapy in Botswana

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

June 2003 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Florida International University

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections, Substance-Related Disorders

Keywords

Treatment Naive, Multivitamins, Selenium, Supplementation, HIV Disease Progression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

878 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Experimental

Arm Description

Multivitamins

Arm Title

Arm Type

Experimental

Arm Description

Multivitamins with Selenium

Arm Title

Arm Type

Experimental

Arm Description

Selenium

Intervention Type

Dietary Supplement

Intervention Name(s)

Multivitamins

Intervention Description

dietary supplement of multivitamins

Intervention Type

Dietary Supplement

Intervention Name(s)

Selenium

Intervention Description

dietary supplement of selenium only

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

placebo pill

Primary Outcome Measure Information:

Title

HIV Disease Progression

Time Frame

For at least 6 months

Secondary Outcome Measure Information:

Title

Morbidity

Time Frame

For at least 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marianna K. Baum, PhD

Organizational Affiliation

Florida International University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Princess Marina Hospital

City

Gaborone

Country

Botswana

12. IPD Sharing Statement

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The Effects of Nutritional Supplementation and Drug Abuse on HIV

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