San Francisco, California 94143

  • HIV Infections

Purpose:

To evaluate and compare the long-term (48-177 weeks) safety, tolerance, and efficacy of two doses of zalcitabine ( dideoxycytidine; ddC ) taken orally every 8 hours in children with symptomatic HIV infection who have one of the following: intolerance to zidovudine ( AZT ) (development of toxicity during prolonged AZT therapy), demonstrated disease progression after 6 months of AZT therapy, OR both AZT intolerance and disease progression after 6 months of AZT therapy. As useful as AZT appears to be in the treatment of patients infected with HIV, it is associated with significant toxicity in some patients, and it does not prevent ultimate progression to AIDS and eventual mortality. Thus, there is a clear need for new antiretroviral drugs, and ddC is one such promising agent.


Study summary:

As useful as AZT appears to be in the treatment of patients infected with HIV, it is associated with significant toxicity in some patients, and it does not prevent ultimate progression to AIDS and eventual mortality. Thus, there is a clear need for new antiretroviral drugs, and ddC is one such promising agent. Patients receive oral ddC for 48 to 177 weeks.


Criteria:

Inclusion Criteria Concurrent Medication: Allowed: - Procrit. - Amphotericin B (1 mg/kg up to 5 days/week). - Prophylaxis treatment as per ACTG recommendations for Pneumocystis carinii pneumonia. - Acyclovir (up to 1000 mg/day PO; for > 1000 mg/day PO or for any IV dose, suggest interrupting ddC). - Ketoconazole (up to 10 mg/kg/day). - Nystatin. - Aspirin, acetaminophen, sedatives, and barbiturates (for up to 72 hours). - Isoniazid (INH), if there is no evidence of peripheral neuropathy at entry. Children should receive pyridoxine, 25 - 50 mg/day to avoid possible INH-associated neuropathy. - Trimethoprim / sulfamethoxazole (T/S). - Immunoglobulin therapy. - Aerosolized pentamidine. - Drugs with little nephro-, hepato-, cytotoxicity that the patient has been taking and tolerating well for an ongoing condition. Concurrent Treatment: Allowed: - Immunoglobulin therapy. - Nutritional support (for children with wasting syndrome and/or malnutritional) including hyperalimentation (TPN) of dietary supplements. AMENDED: - Patients enrolled in ACTG 051 may participate in ACTG 138 if they show intolerance to AZT or show disease progression after 6 months of AZT therapy and meet entry criteria for the study. ORIGINAL design: - Patients enrolled in ACTG protocols 051 or 128 must meet study end points or meet protocol definitions for being permanently off zidovudine (AZT) before enrolling in this protocol. Patients must have the following: - Absence of acute opportunistic infection at time of entry. - However, if patient is successfully treated for opportunistic infection and has remained stable for 2 weeks after treatment, the patient is then allowed to enter the study. Children receiving maintenance therapy for > 4 weeks are eligible. - Parent or guardian available to give written informed consent. Allowed at time of study entry: - Prophylaxis treatment as per ACTG recommendations, for Pneumocystis carinii pneumonia (PCP). - Immunoglobulin therapy. Prior Medication: AMENDED: - AZT or ddI up until study entry, other antiretrovirals up until 4 weeks of study entry Allowed: - Zidovudine (AZT) within 4 weeks of entry. - Dideoxyinosine (ddI) within 43 weeks of entry if no peripheral neuropathy has been observed while receiving ddI. - Other toxicities observed while on ddI must resolve to level 2 or better before patient can begin treatment with ddC. - Vitamin, folate, iron supplements. Exclusion Criteria Co-existing Condition: AMENDED: - 04-25-91 Additional excluded symptoms and conditions: - Symptomatic cardiomyopathy. - Seizures which are not well controlled by ongoing anticonvulsant therapy. - Active malignancy requiring concomitant chemotherapy. - Symptomatic pancreatitis. - Grade I or greater peripheral neuropathy. - Receiving concomitant zidovudine (AZT). - Patients with the following conditions or symptoms are excluded: - Acute bacterial infections requiring IV or oral antibiotic treatment at time of entry. - Known hypersensitivity to dideoxycytidine (ddC). Concurrent Medication: Excluded: - Other antiviral agents, biological modifiers, and investigational medications. - Drugs with potential to cause peripheral neuropathy, including chloramphenicol, iodoquinol, phenytoin, ethionamide, gold, ribavirin, vincristine, cisplatin, dapsone, disulfiram, glutethimide, hydralazine, metronidazole, nitrofurantoin. Patients with the following are excluded: - Acute bacterial infections requiring IV or oral antibiotic treatment at time of entry. - Known hypersensitivity to dideoxycytidine (ddC). - Active opportunistic infection requiring treatment with an excluded concomitant medication. Prior Medication: Excluded: - Antiretroviral agents (other than zidovudine (AZT) or didanosine (ddI)) within 4 weeks of entry. - Immunomodulating agents such as interferons, isoprinosine, or interleukin-2 within 2 weeks of entry. - Any other experimental therapy, drugs that cause prolonged neutropenia, significant nephrotoxicity, or peripheral neuropathy within 1 week of entry.


Study is Available At:


Original ID:

ACTG 138


NCT ID:

NCT00000653


Secondary ID:

11113


Study Acronym:


Brief Title:

A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who S


Official Title:

A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

3 Months


Maximum Age:

18 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Allergy and Infectious Diseases (NIAID)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

140


Enrollment Type:


Overall Contact Information

Official Name:Spector SA
Study Chair

Study Dates

Completion Date:June 1995
Completion Type:Actual
Verification Date:March 2012
Last Changed Date:March 29, 2012
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Zalcitabine

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Allergy and Infectious Diseases (NIAID)
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Hoffmann-La Roche

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Dankner WM, Lindsey JC, Levin MJ. Correlates of opportunistic infections in children infected with the human immunodeficiency virus managed before highly active antiretroviral therapy. Pediatr Infect Dis J. 2001 Jan;20(1):40-8.
PMID:11176565
Reference Type:Reference
Citation:Spector SA, Blanchard S, Connor EM, Salgo MP, McNamara J. Results of a clinical trial comparing two doses of 2'3'-dideoxycytidine (ddC) in the treatment of children with symptomatic human immunodeficiency virus (HIV) infection who were intolerant or had failed zidovudine (ZDV) therapy (ACTG 138). The Pediatric AIDS Clinical Trials 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)

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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