Completed

A Multicenter Trial To Evaluate Oral Retrovir in the Treatment of Children With Symptomatic HIV Infection

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What is being tested

Zidovudine

Drug
Who is being recruted

HIV Infections

From 3 Months to 12 Years
How is the trial designed

Treatment Study

Phase 2
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: March 14, 2011
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To evaluate the safety and tolerance of oral zidovudine (AZT) when given over a period of 24 weeks to children between 3 months and 12 years of age. The effectiveness of AZT in treating HIV infection in infants and children will also be evaluated. HIV infection in children is most often associated with symptomatic disease and poor prognosis. Treatment with antiviral therapy may be effective in altering the course of the disease and decreasing mortality in these children. AZT has been shown to be effective in certain adult patients with symptomatic HIV infection. It is therefore likely that infected children may also benefit from this treatment. HIV infection in children is most often associated with symptomatic disease and poor prognosis. Treatment with antiviral therapy may be effective in altering the course of the disease and decreasing mortality in these children. AZT has been shown to be effective in certain adult patients with symptomatic HIV infection. It is therefore likely that infected children may also benefit from this treatment. The participants receive AZT mixed with juice at a dose dependent on body size every 6 hours for 24 weeks. The children are evaluated weekly for the first 4 weeks, every two weeks for the subsequent 8 weeks, and monthly thereafter. Blood samples are collected periodically and cerebrospinal fluid (CSF) by lumbar puncture on 2 occasions.

Official TitleA Multicenter Trial To Evaluate Oral Retrovir in the Treatment of Children With Symptomatic HIV Infection 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: March 14, 2011
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
70 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 3 Months to 12 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
Criteria
No eligibility criteria are available at this time.Please check with the study contact for more details. 
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 9 locations
Suspended
Los Angeles County - USC Med CtrLos Angeles, United StatesSee the location
Suspended
San Francisco AIDS Clinic / San Francisco Gen HospSan Francisco, United States
Suspended
Univ of Miami School of MedicineMiami, United States
Suspended
Johns Hopkins Hosp - PediatricBaltimore, United States

Completed9 Study Centers