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Zinc Therapy in HIV Infected Individuals Who Abuse Drugs

Florida International University (FIU) logo

Florida International University (FIU)

Status

Completed

Conditions

Substance-Related Disorders
HIV Infections

Treatments

Dietary Supplement: zinc

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00149552
R01DA014966 (U.S. NIH Grant/Contract)
NIDA-14966-1

Details and patient eligibility

About

Zinc deficiency is prevalent in HIV infected individuals who abuse drugs. The purpose of this study is to determine if zinc therapy will prevent immune failure in HIV infected individuals who abuse drugs and have low plasma zinc levels.

Full description

Low levels of zinc are associated with an increased risk of HIV-related death and opportunistic infections in HIV infected individuals. Drug users are especially susceptible to zinc deficiency. The purpose of this trial is to evaluate the effectiveness of zinc therapy in preventing immune failure in HIV infected individuals who abuse drugs.

This trial will last 30 months. Participants will be randomly assigned to receive either zinc supplements or placebo. Male participants will receive 15 mg of zinc and female participants will receive 12 mg of zinc. Clinical and laboratory study visits will occur at 3 or 6 month intervals throughout the study.

Enrollment

231 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • HIV infected
  • Drug User
  • Blood zinc level greater than 0.35 mcg/mL and less than 0.75mcg/ml

Exclusion criteria

  • Currently participating in an another clinical trial
  • Blood selenium level less than 85 mcg/L
  • Pregnant or intends to become pregnant

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

231 participants in 2 patient groups, including a placebo group

Zinc gluconate
Active Comparator group
Description:
Zinc supplementation
Treatment:
Dietary Supplement: zinc
Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Dietary Supplement: zinc

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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