A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT

HIV Infections Clinical Trial

Official title:

A Phase II Study to Evaluate Pharmacokinetics, Safety, Tolerance and Activity of Dideoxycytidine (ddC) Administered in Combination With Zidovudine (AZT) in Stable, AZT-Treated Pediatric Patients With HIV Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001032
• Other study ID #: ACTG 190
• Secondary ID: 11165
• Status: Completed
• Phase: Phase 2
• Est. completion date: April 1995

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

PRIMARY: To determine safety, tolerance, and pharmacokinetics of zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) when given in combination in clinically stable AZT-treated children.

SECONDARY: To compare combination therapy with mono drug therapy for antiviral activity and laboratory markers of disease progression, as determined by virologic and immunologic determinations. To evaluate the influence of combination therapy on disease progression as determined by evaluation of clinical criteria.

In children currently being treated with AZT, it is unknown whether the addition of another antiretroviral agent such as ddC would help increase efficacy and tolerance. This study will examine the possible advantages of combination AZT/ddC therapy over monotherapy with AZT alone.

Description:

In children currently being treated with AZT, it is unknown whether the addition of another antiretroviral agent such as ddC would help increase efficacy and tolerance. This study will examine the possible advantages of combination AZT/ddC therapy over monotherapy with AZT alone.

Patients are stratified according to duration of ongoing AZT therapy and are randomized to receive AZT either alone or in combination with ddC. Patients receive therapy until the last patient enrolled completes 32 weeks of therapy. The study may be extended for two additional 32-week periods on an optional basis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 1995
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 12 Years

Eligibility

Inclusion Criteria

Concurrent Medication:

Recommended:

• PCP prophylaxis.

Allowed:

• Intravenous and/or intramuscular immunoglobulin.

• Acyclovir (no more than 30 mg/kg/day PO).

• Ketoconazole (no more than 10 mg/kg/day).

• Nystatin.

• Aspirin, acetaminophen, nonsteroidal anti-inflammatory drugs, sedatives, and barbiturates, not to exceed 72 hours.

• Isoniazid in combination with pyridoxine, provided there is no evidence of peripheral neuropathy.

• Trimethoprim / sulfamethoxazole.

• Amphotericin B (no more than 1 mg/kg for 5 days/week).

• Aerosolized ribavirin for bronchiolitis.

• Hematopoietic agents.

• Other drugs with little nephro-, hepato-, or cytotoxicity.

• Nutritional support for HIV wasting syndrome or malnutrition.

Patients must have:

• HIV infection.

• Ongoing stable AZT therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

• Disease progression while on AZT, to the extent that the patient meets the criteria for advanced disease protocols.

• Known allergy or sensitivity to ddC.

• Cardiomyopathy.

Concurrent Medication:

Excluded:

• Biologic modifiers other than IVIG, steroids, or hematopoietic agents.

• Investigational medications unless approved by protocol chair.

• Medications known to cause pancreatitis (unless ddC is interrupted while these medications are given).

Patients with the following prior conditions are excluded:

• History of intolerance or toxicity to AZT.

• History of symptomatic pancreatitis.

• History of peripheral neuropathy or abnormal nerve conduction velocity test.

Prior Medication:

Excluded:

• Antiretroviral agents other than AZT within 2 weeks of study entry.

Required:

• Ongoing stable AZT therapy for more than 6 weeks duration.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infections

Intervention

Drug:
• Zidovudine

• Zalcitabine

Locations

Country	Name	City	State
Puerto Rico	Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.	Bayamon
Puerto Rico	San Juan City Hosp. PR NICHD CRS	San Juan
Puerto Rico	Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS	San Juan
United States	Children's Hospital at Albany Medical Center, Dept. of Peds.	Albany	New York
United States	Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases	Atlanta	Georgia
United States	Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology	Baltimore	Maryland
United States	BMC, Div. of Ped Infectious Diseases	Boston	Massachusetts
United States	HMS - Children's Hosp. Boston, Div. of Infectious Diseases	Boston	Massachusetts
United States	Bronx-Lebanon Hosp. IMPAACT CRS	Bronx	New York
United States	SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS	Brooklyn	New York
United States	Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases	Charleston	South Carolina
United States	Chicago Children's CRS	Chicago	Illinois
United States	Cook County Hosp.	Chicago	Illinois
United States	Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease	Chicago	Illinois
United States	Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.	Chicago	Illinois
United States	Children's Hospital of Michigan NICHD CRS	Detroit	Michigan
United States	DUMC Ped. CRS	Durham	North Carolina
United States	Univ. of Connecticut Health Ctr., Dept. of Ped.	Farmington	Connecticut
United States	North Shore-Long Island Jewish Health System, Dept. of Peds.	Great Neck	New York
United States	Long Beach Memorial Med. Ctr., Miller Children's Hosp.	Long Beach	California
United States	UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS	Los Angeles	California
United States	Usc La Nichd Crs	Los Angeles	California
United States	Univ. of Miami Ped. Perinatal HIV/AIDS CRS	Miami	Florida
United States	UMDNJ - Robert Wood Johnson	New Brunswick	New Jersey
United States	Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease	New Haven	Connecticut
United States	Schneider Children's Hosp., Div. of Infectious Diseases	New Hyde Park	New York
United States	Tulane/LSU Maternal/Child CRS	New Orleans	Louisiana
United States	Columbia IMPAACT CRS	New York	New York
United States	Harlem Hosp. Ctr. NY NICHD CRS	New York	New York
United States	Incarnation Children's Ctr.	New York	New York
United States	Metropolitan Hosp. NICHD CRS	New York	New York
United States	NYU Med. Ctr., Dept. of Medicine	New York	New York
United States	Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.	Oakland	California
United States	St. Joseph's Hosp. & Med. Ctr. of New Jersey	Paterson	New Jersey
United States	St. Christopher's Hosp. for Children	Philadelphia	Pennsylvania
United States	The Children's Hosp. of Philadelphia IMPAACT CRS	Philadelphia	Pennsylvania
United States	Univ. of Rochester ACTG CRS	Rochester	New York
United States	UCSD Maternal, Child, and Adolescent HIV CRS	San Diego	California
United States	San Francisco Gen. Hosp.	San Francisco	California
United States	UCSF Pediatric AIDS CRS	San Francisco	California
United States	UW School of Medicine - CHRMC	Seattle	Washington
United States	Baystate Health, Baystate Med. Ctr.	Springfield	Massachusetts
United States	SUNY Upstate Med. Univ., Dept. of Peds.	Syracuse	New York
United States	Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases	Torrance	California
United States	Children's National Med. Ctr., ACTU	Washington	District of Columbia
United States	Howard Univ. Washington DC NICHD CRS	Washington	District of Columbia
United States	WNE Maternal Pediatric Adolescent AIDS CRS	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (2)

Bakshi SS, Britto P, Capparelli E, Mofenson L, Fowler MG, Rasheed S, Schoenfeld D, Zimmer B, Frank Y, Yogev R, Jimenez E, Salgo M, Boone G, Pahwa SG. Evaluation of pharmacokinetics, safety, tolerance, and activity of combination of zalcitabine and zidovudine in stable, zidovudine-treated pediatric patients with human immunodeficiency virus infection. AIDS Clinical Trials Group Protocol 190 Team. J Infect Dis. 1997 May;175(5):1039-50. — View Citation

Perrier M, Schwarz T, Gonzalez O, Brounts S. Squamous cell carcinoma invading the right temporomandibular joint in a Belgian mare. Can Vet J. 2010 Aug;51(8):885-7. — View Citation