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

NCT00000716 | Completed Phase 2

• 5 other identifiers: ACTG 043NCI-T88-0191NProtocol 26,341--08Project P53FDA 9C
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

HIV Infections

Keywords

Drug Evaluation; Administration, Oral; Acquired Immunodeficiency Syndrome; Zidovudine

Interventions

Zidovudine DRUG

Eligibility Criteria

• Age: 3 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Concurrent Medication:
• Allowed:
• Amphotericin B and antituberculosis chemotherapy.
• Children who have advanced lymphocytic interstitial pneumonitis (LIP) who are steroid dependent may remain on such therapy.
• Secondary prophylaxis for Pneumocystis carinii pneumonia (PCP) with careful monitoring for possible toxicity due to combination therapy with zidovudine (AZT).
• Concurrent Treatment:
• Allowed:
• Blood transfusions for hematologic toxicity.
• Immunoglobulin therapy for development of = or \> 3 serious bacterial infections while receiving zidovudine. A serious bacterial infection includes septicemia (not catheter related), pneumonia, meningitis, bone or joint infection, or abscess of the body cavity or internal organ.
• The pathogen must be one of the following organisms:
• Staphylococcus aureus, Streptococcus pyogenes, Escherichia coli, Streptococcus group B, Pseudomonas aeruginosa, Hemophilus influenzae B, and Pneumococcus. Laboratory documentation of the pathogen is required.
• Patients must comply with the following:
• Life expectancy of more than 6 months.
• Children must have laboratory evidence of HIV infections as demonstrated by either a positive viral culture or detectable serum p24 antigen or repeated positive test for HIV antibody determined by a federally licensed ELISA test and confirmed by Western blot.
• Children under 15 months of age, who are thought to have acquired HIV through perinatal transmission and whose only laboratory evidence of HIV infection is a positive antibody test, must also have increased immunoglobulin levels and decreased absolute number of CD4+ cells or a decreased helper/suppressor ratio.

You may not qualify if:

• Co-existing Condition:
• Patients with the following will be excluded:
• Any active or chronic opportunistic infection at time of entry requiring acute therapy with experimental agents or agents which may affect zidovudine (AZT) toxicity or safety, nor serious bacterial, fungal, or parasitic infections requiring parenteral therapy at the time of entry.
• Concurrent Medication:
• Concomitant medications should be kept to a minimum.
• Excluded:
• Chronic use of drugs that are metabolized by hepatic glucuronidation, such as acetaminophen.
• Acute therapy for active or chronic opportunistic infection with experimental agents or agents which may affect zidovudine (AZT) toxicity.
• Parenteral therapy for serious bacterial, fungal, or parasitic infections.
• Prophylaxis for Pneumocystis carinii pneumonia (PCP) for children who have not had a previous episode of PCP, oral candidiasis, or otitis media.
• Immunoglobulin therapy. Note: Immunoglobulin therapy may be administered to children who develop = \> 3 serious bacterial infections while receiving AZT.
• Children with lymphocytic interstitial pneumonitis (LIP) as their only clinical sign of HIV infection will be excluded from the study. Children with any of the following laboratory findings within 2 weeks of entry will be excluded:
• A total bilirubin \> 3 times Upper Limit of Normal (ULN).
• SGOT \> 5 x Upper Limit of Normal in the presence of an age-adjusted abnormal bilirubin.
• Creatinine clearance \< 50 ml/min/1.73 m2.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (9)

Los Angeles County - USC Med Ctr

Los Angeles, California, 90033, United States

Location

San Francisco AIDS Clinic / San Francisco Gen Hosp

San Francisco, California, 941102859, United States

Location

Univ of Miami School of Medicine

Miami, Florida, 331361013, United States

Location

Johns Hopkins Hosp - Pediatric

Baltimore, Maryland, 212874933, United States

Location

Johns Hopkins Hosp

Baltimore, Maryland, 21287, United States

Location

Children's Hosp of Boston

Boston, Massachusetts, 021155724, United States

Location

Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl

Newark, New Jersey, 071072198, United States

Location

Bellevue Hosp / New York Univ Med Ctr

New York, New York, 10016, United States

Location

Duke Univ Med Ctr

Durham, North Carolina, 27710, United States

Location

Related Publications (6)

• McKinney RE Jr, Wilfert C. Growth as a prognostic indicator in children with human immunodeficiency virus infection treated with zidovudine. AIDS Clinical Trials Group Protocol 043 Study Group. J Pediatr. 1994 Nov;125(5 Pt 1):728-33. doi: 10.1016/s0022-3476(94)70065-6.

  PMID: 7965424 BACKGROUND

• McKinney RE Jr, Maha MA, Connor EM, Feinberg J, Scott GB, Wulfsohn M, McIntosh K, Borkowsky W, Modlin JF, Weintrub P, et al. A multicenter trial of oral zidovudine in children with advanced human immunodeficiency virus disease. The Protocol 043 Study Group. N Engl J Med. 1991 Apr 11;324(15):1018-25. doi: 10.1056/NEJM199104113241503.

  PMID: 1672443 BACKGROUND

• Connor E. Lymphocyte subset changes in children with advanced symptomatic HIV infection treated with oral zidovudine. Int Conf AIDS. 1990 Jun 20-23;6(2):95 (abstract no FB21)

  BACKGROUND

• Kavanaugh-McHugh A, Ruff A, Rowe S, Holt E, Modlin J, Maha M, Wilfert C. Cardiac abnormalities in pediatric HIV infection. Int Conf AIDS. 1990 Jun 20-23;6(2):198 (abstract no FB483)

  BACKGROUND

• McKinney RE, Wilfert CM. The efficacy of oral, intermittent zidovudine (ZDV) in a phase II pediatric trial (AIDS clinical trials group study 043). Int Conf AIDS. 1990 Jun 20-23;6(2):94 (abstract no FB18)

  BACKGROUND

• McKinney RS. Markers prognostic for survival in zidovudine treated, HIV infected children. ACTG Protocol 043 Study Group. American Pediatric Society 104th annual meeting and Society for Pediatric Research 63rd annual meeting; 1994 May 2-5; Seattle. Pediatr AIDS HIV Infect. 1994 Oct;5(5):323 (unnumbered abstract)

  BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Wilfert C

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Primary Completion: January 1, 1991
• Last Updated: March 14, 2011

Record last verified: 1990-05

Locations

US (9)