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A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection Clinical research trials and A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection. A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection clinical trial. Subjects often receive the most expert healthcare possible for their A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.

Home > "A" Clinical Trials Conditions > A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection

A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection



A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection

For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Glaxo Wellcome
Synopsis: Primary: To determine the efficacy of early treatment with zidovudine (AZT) in HIV-infected asymptomatic infants. To determine the safety and tolerance of AZT in this patient population. Secondary: To compare the virologic and immunologic parameters between the treatment groups. To determine the efficacy of AZT as an early treatment to prevent development of CD4+ cell depletion in HIV-infected asymptomatic infants. AZT is currently indicated for primary treatment in children with HIV-associated signs and symptoms and for those with significant immunodeficiency. This study will attempt to determine whether early treatment with AZT prevents the development of symptoms in HIV-infected infants who are asymptomatic.
Details: AZT is currently indicated for primary treatment in children with HIV-associated signs and symptoms and for those with significant immunodeficiency. This study will attempt to determine whether early treatment with AZT prevents the development of symptoms in HIV-infected infants who are asymptomatic. Patients are randomized to receive oral AZT (at age-adjusted doses) or placebo. Patients are evaluated at weeks 2 and 4 and every 4 weeks thereafter; those who reach a study endpoint will have their treatment unblinded to allow the clinician to determine which treatment regimen the patient should then receive. Patients who meet the criteria for changes to open-label AZT will be given the appropriate age-adjusted dose without unblinding the original randomization assignment. Patients who complete or discontinue treatment are followed every 6 months for up to 2 years.
Eligibility:
Study Type:
  Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: /9 Months
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HIV infection. - CD4 count >= 2000 cells/mm3 AND >= 30 percent of total lymphocytes. - No signs or symptoms of HIV infection (other than lymphadenopathy, mild hepatomegaly, hypergammaglobulinemia, or splenomegaly, which is permitted). - Consent of parent or guardian. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: - Serious acute infection requiring parenteral therapy at time of entry. - One or more serious, proven bacterial infections including any of the following: - septicemia; pneumonia; meningitis; bone or joint infection; or abscess of an internal organ or body cavity (excluding otitis media or superficial skin or mucosal abscesses) that are caused by Haemophilus, Streptococcus (including pneumococcus), or other pyogenic bacteria. - Clinical neurologic/neuropsychologic deficits, or a head circumference less than the fifth percentile. Concurrent Medication: Excluded: - Any agent with known antiretroviral activity. - Acetaminophen, ibuprofen, or aspirin for more than 72 hours continuously. Prior Medication: Excluded: - More than 7 weeks of prior antiretroviral or immunomodulator therapy post-natally. Recommended: - PCP prophylaxis. - Immunizations according to current recommendations.
Total Enrollment: 400

Location and Contact Information:

Overall Study Official:
EConnor,  Study Chair, 

Lincoln Hosp Ctr
Bronx,  New York,  10451
United States
 

Univ of Connecticut / Farmington
Farmington,  Connecticut,  06032
United States
 

Children's Med Ctr of Dallas
Dallas,  Texas,  75235
United States
 

Duke Univ Med Ctr
Durham,  North Carolina,  277103499
United States
 

Albert Einstein College of Medicine
Bronx,  New York,  10461
United States
 

UCLA Med Ctr / Pediatric
Los Angeles,  California,  900951752
United States
 

Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark,  New Jersey,  071032714
United States
 

Westchester Hosp
Valhalla,  New York,  10595
United States
 

Children's Hosp at Albany Med Ctr
Albany,  New York,  12208
United States
 

Yale Univ Med School
New Haven,  Connecticut,  06504
United States
 

Metropolitan Hosp Ctr
New York City,  New York,  10029
United States
 

Children's Hosp of Washington DC
Washington D.C.,  District of Columbia,  200102916
United States
 

Univ of Massachusetts Med School
Worcester,  Massachusetts,  016550001
United States
 

Univ of Illinois College of Medicine / Pediatrics
Chicago,  Illinois,  60612
United States
 

Med Univ of South Carolina
Charleston,  South Carolina,  294253312
United States
 

Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore,  Maryland,  21201
United States
 

King's County Hosp Ctr / Pediatrics
Brooklyn,  New York,  11203
United States
 

Cook County Hosp
Chicago,  Illinois,  60612
United States
 

San Juan City Hosp
San Juan,  ,  009367344
Puerto Rico
 

Kaiser Permanente / UCLA Med Ctr
Downey,  California,  902422814
United States
 

Saint Jude Children's Research Hosp of Memphis
Memphis,  Tennessee,  381052794
United States
 

UCSF / Moffitt Hosp - Pediatric
San Francisco,  California,  941430105
United States
 

Tulane Univ / Charity Hosp of New Orleans
New Orleans,  Louisiana,  701122699
United States
 

Univ of Miami (Pediatric)
Miami,  Florida,  33161
United States
 

Children's Hosp Pact Prog / Children's Hosp of Buffalo
Buffalo,  New York,  14222
United States
 

North Shore Univ Hosp
Great Neck,  New York,  11021
United States
 

Columbus Children's Hosp
Columbus,  Ohio,  432052696
United States
 

Georgetown Univ Med Ctr
Washington D.C.,  District of Columbia,  20007
United States
 

Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark,  New Jersey,  071072198
United States
 

Baystate Med Ctr of Springfield
Springfield,  Massachusetts,  01199
United States
 

Univ of Rochester Medical Center
Rochester,  New York,  14642
United States
 

San Francisco Gen Hosp
San Francisco,  California,  94110
United States
 

Children's Hosp of Boston
Boston,  Massachusetts,  021155724
United States
 

Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham,  Alabama,  35294
United States
 

Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles,  California,  905022004
United States
 

Mount Sinai Med Ctr / Pediatrics
New York City,  New York,  10029
United States
 

Children's Hosp of Denver
Denver,  Colorado,  802181088
United States
 

Howard Univ Hosp
Washington D.C.,  District of Columbia,  20060
United States
 

Univ of Chicago Children's Hosp
Chicago,  Illinois,  606371470
United States
 

Chicago Children's Memorial Hosp
Chicago,  Illinois,  606143394
United States
 

Harlem Hosp Ctr
New York City,  New York,  10037
United States
 

Bronx Lebanon Hosp Ctr
Bronx,  New York,  10457
United States
 


Additional Information:
Study ID Numbers:
  ACTG 182; 
Study Start Date: 
Record last reviewed: October 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000750

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4. A Study of Peer Education to Prevent HIV Transmission among Injection Drug Users and Their HIV Risk Contacts

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A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection

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