Clinical trial NCT00000971: The Safety and Effectiveness of Clarithromycin Plus Zidovudine or Dideoxyinosine in the Treatment of Mycobacterium Avium Complex (MAC) Infections in Children With AIDS
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mycobacterium Avium-intracellulare Infection
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Mycobacterium avium-intracellulare Infection
Didanosine
Drug Evaluation
Drug Interactions
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Zidovudine
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2001-08-31
Enrollment: 24
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate three doses of clarithromycin in children with AIDS and Mycobacterium avium complex (MAC) infection who are receiving concurrent antiretroviral therapy.

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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hosp of Los Angeles
state: California
city: Bethesda
country: United States
facility: Natl Cancer Institute / HIV / AIDS Malignancy Branch
state: Maryland
Study officials:
name: Pizzo P
role: STUDY_CHAIR
name: Husson R
role: STUDY_CHAIR
References:
citation: Husson RN, Ross LA, Sandelli S, Inderlied CB, Venzon D, Lewis LL, Woods L, Conville PS, Witebsky FG, Pizzo PA. Orally administered clarithromycin for the treatment of systemic Mycobacterium avium complex infection in children with acquired immunodeficiency syndrome. J Pediatr. 1994 May;124(5 Pt 1):807-14. doi: 10.1016/s0022-3476(05)81380-0.