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A Phase I/II Dose-Ranging, Pharmacokinetic, Drug Interaction, Safety and Preliminary Efficacy Study of Oral Clarithromycin Granules for Suspension, in Combination With Zidovudine or Dideoxyinosine, in the Treatment of Disseminated Mycobacterium Avium Complex Infections in Pediatric Patients With AIDS


Phase 1
3 Months
18 Years
Not Enrolling
Both
Mycobacterium Avium-Intracellulare Infection, HIV Infections

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Trial Information

A Phase I/II Dose-Ranging, Pharmacokinetic, Drug Interaction, Safety and Preliminary Efficacy Study of Oral Clarithromycin Granules for Suspension, in Combination With Zidovudine or Dideoxyinosine, in the Treatment of Disseminated Mycobacterium Avium Complex Infections in Pediatric Patients With AIDS


Before more extensive evaluation of this promising drug for treatment of MAC infection in
children can be done, it is important to study the pharmacokinetics of this drug in this
population, to get information regarding its use in pediatric patients receiving currently
available antiretroviral drugs, and to get information on the antimycobacterial activity of
this drug.

Patients that are included are HIV infected and have started zidovudine (AZT) or didanosine
(ddI) at least 4 weeks before entry into this study. Patients continue taking the
medications at prescribed doses. In addition they also take clarithromycin. Patients
continue treatment with AZT or ddI plus clarithromycin for 12 weeks.

Inclusion Criteria


Inclusion Criteria

Concurrent Medication:

Allowed:

- Prophylaxis treatment for Pneumocystis carinii pneumonia.

- Topical antivirals.

Prior Medication: Required:

- Zidovudine (AZT), 90 - 180 mg/m2 q6h, or didanosine (ddI), 60 - 120 mg/m2 q8h for 4
weeks prior to study entry.

Patients must have the following:

- Diagnosis of AIDS and Mycobacterium avium complex.

- Ability to tolerate therapy with zidovudine or didanosine at specified dosages.

- Written consent from a parent or legal guardian.

- Willing to comply with all procedures and scheduled visits. Relatively stable
clinical condition.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

- History of significant depressive disorder.

- History of allergy to macrolide antibiotics.

- Presence of acute bacterial infection or acute onset of opportunistic infection as
listed in protocol.

Patients with the following are excluded:

- Presence of current opportunistic infection other than Mycobacterium avium complex
defined as systemic candidemia, cryptosporidiosis, isosporiasis, toxoplasmosis,
pneumocystosis, salmonellosis, or acute bacterial infection.

Prior Medication:

Excluded within 30 days of study entry:

- Systemic antimycobacterial drugs, myelosuppressive drugs, nephrotoxic agents,
cytotoxic or experimental chemotherapy, or antiviral drugs.

Active alcohol or drug use sufficient in the opinion of the investigator to prevent
adequate compliance with medication regimen and clinic visits.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Pizzo P

Investigator Role:

Study Chair

Authority:

Unspecified

Study ID:

ACTG 178

NCT ID:

NCT00000971

Start Date:

Completion Date:

Related Keywords:

  • Mycobacterium Avium-Intracellulare Infection
  • HIV Infections
  • AIDS-Related Opportunistic Infections
  • Mycobacterium avium-intracellulare Infection
  • Didanosine
  • Drug Evaluation
  • Drug Interactions
  • Drug Therapy, Combination
  • Acquired Immunodeficiency Syndrome
  • Zidovudine
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Mycobacterium Infections
  • Mycobacterium avium-intracellulare Infection

Name

Location

Children's Hosp of Los AngelesLos Angeles, California  90027
Natl Cancer Institute / HIV / AIDS Malignancy BranchBethesda, Maryland  20892