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A Phase I Study to Evaluate the Safety and Toxicity of the Combination of Zidovudine and 2',3'-Dideoxyinosine (Didanosine) in Children With HIV Infection


Phase 1
3 Months
18 Years
Not Enrolling
Both
HIV Infections

Thank you

Trial Information

A Phase I Study to Evaluate the Safety and Toxicity of the Combination of Zidovudine and 2',3'-Dideoxyinosine (Didanosine) in Children With HIV Infection


New approaches to using available agents may provide increased or improved treatment options
for AIDS. Combination therapy is expected to play a major role in improving survival and
quality of life for HIV-infected individuals. AZT and ddI are two agents that have been most
extensively evaluated and for which the evidence for antiretroviral effectiveness is
strongest.

Patients take AZT and ddI on an empty stomach; ddI is taken 2 minutes after taking antacid.
Part A patients receive AZT plus ddI each at ranging doses. Patients in part B may receive
a higher dose of ddI than patients in part A. The first patients enrolled are given the
lowest dose. Subsequent patients receive increasingly higher doses until a dose limiting
toxicity occurs.

Inclusion Criteria


Inclusion Criteria

Concurrent Medication:

Allowed:

- Corticosteroids for treatment of lymphocytic interstitial pneumonitis.

Concurrent Treatment:

Allowed:

- Intravenous hyperalimentation.

Patients must have the following:

- P-2 class symptomatic HIV infection as defined by CDC OR who are asymptomatic but
whose total CD4 cell count is < 500 cells/mm3.

- Freedom from significant active opportunistic or other infection requiring specific
therapy.

Part B patients:

- Prior treatment with zidovudine (AZT) that was discontinued because of hematologic
toxicity.

- Availability of a parent or legal guardian who is sufficiently reliable to give
informed consent and follow necessary study procedures including administration of
medications and return for follow-up visits.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

- Critically ill, clinically unstable, or receiving drug therapy for an opportunistic
or other infection.

- History of acute or chronic pancreatitis.

Patients with the following are excluded:

- Critically ill, clinically unstable, or receiving drug therapy for an opportunistic
or other infection.

- History of acute or chronic pancreatitis.

Prior Medication:

Excluded:

- Antiretroviral or other antiviral agent within 14 days of entry into study.

- Immunomodulating agents, cytolytic chemotherapeutic agents, corticosteroids within 30
days (except for lymphocytic interstitial pneumonitis).

Part A patients:

- Zidovudine (AZT) or didanosine (ddI).

Part B patients:

- Didanosine (ddI).

Prior Treatment:

Excluded:

- Radiation therapy within 30 days.

- Intravenous immunoglobulin preparations within 14 days of entry into study.

Type of Study:

Interventional

Study Design:

Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Principal Investigator

PA Pizzo

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 176

NCT ID:

NCT00000652

Start Date:

Completion Date:

November 1995

Related Keywords:

  • HIV Infections
  • Didanosine
  • Drug Evaluation
  • Drug Therapy, Combination
  • Zidovudine
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

Name

Location

Children's Hosp of Los Angeles/UCLA Med CtrLos Angeles, California  900276016