NCT00149656

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
878

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
Completed

Started Jun 2003

Longer than P75 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 29, 2013

Status Verified

April 1, 2013

Enrollment Period

7.1 years

First QC Date

September 6, 2005

Last Update Submit

April 26, 2013

Conditions

HIV InfectionsSubstance-Related Disorders

Keywords

Treatment NaiveMultivitaminsSeleniumSupplementationHIV Disease Progression

Outcome Measures

Primary Outcomes (1)

  • HIV Disease Progression

    For at least 6 months

Secondary Outcomes (1)

  • Morbidity

    For at least 6 months

Study Arms (4)

1

PLACEBO COMPARATOR
Other: Placebo

2

EXPERIMENTAL

Multivitamins

Dietary Supplement: Multivitamins

3

EXPERIMENTAL

Multivitamins with Selenium

Dietary Supplement: MultivitaminsDietary Supplement: Selenium

4

EXPERIMENTAL

Selenium

Dietary Supplement: Selenium

Interventions

MultivitaminsDIETARY_SUPPLEMENT

dietary supplement of multivitamins

23
SeleniumDIETARY_SUPPLEMENT

dietary supplement of selenium only

34
PlaceboOTHER

placebo pill

1

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Marina Hospital

Gaborone, Botswana

Location

MeSH Terms

Conditions

HIV InfectionsSubstance-Related Disorders

Interventions

GeritolSelenium

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsMinerals

Study Officials

  • Marianna K. Baum, PhD

    Florida International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

June 1, 2003

Primary Completion

July 1, 2010

Study Completion

April 1, 2013

Last Updated

April 29, 2013

Record last verified: 2013-04

Locations

BO(1)