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Completed

NCT Number: NCT00149656

The Effects of Nutritional Supplementation and Drug Abuse on HIV

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Marina Hospital

Gaborone, Botswana

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multivitamins

Dietary Supplement

dietary supplement of multivitamins

Selenium

Dietary Supplement

dietary supplement of selenium only

Placebo

Other

placebo pill

Primary outcomes

  1. HIV Disease Progression

    Time frame: For at least 6 months

Secondary outcomes

  1. Morbidity

    Time frame: For at least 6 months

Sponsors and collaborators

Lead sponsor

Florida International University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

HIV Disease, Drug Abuse, and Nutrient Therapy in Botswana

Important dates

Study start
2003
Primary completion
2010
Study completion
2013
First posted
Sep 8, 2005
Registry last updated
Apr 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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