Comparison of New Anti-HIV Drug Combinations in HIV-Infected Children Who Have Taken Anti-HIV Drugs

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

For PRAM-1: Evidence supports combination therapy with 2 or more antiviral agents as beneficial in the long-term management of HIV. The possibility exists that combination therapy may result in a synergistic or additive activity over a prolonged period of time. Also hypothesized is that the development of resistance to individual agents will be developed if viral replication is significantly decreased.

AS PER AMENDMENT 10/20/97: For PRAM-1, Step 2: Interim analysis at 12 weeks on PRAM-1 indicates that the proportion of children reaching undetectable RNA levels on the ZDV + 3TC arm is signi...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • IVIG and opportunistic infection prophylaxis will be allowed.
• • Erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) and granulocyte-macrophage colony- stimulating factor (GM-CSF) will be allowed for the management of hematologic toxicity.
• • Treatment with trimethoprim is allowed at the discretion of the principal investigator.
• Patients must have:
• • Laboratory evidence (at least 2 viral tests) of HIV-1 infection.
• • Clinical and immunological stability \[maintained CDC category 1 or 2 immunologic status for past 4 months and no new CDC category (diagnosis within the past year)\].
• • Patients must have received continuous antiretroviral therapy for the past 16 weeks (missing no more than 6 weeks of therapy during the previous 16 weeks).
• AS PER AMENDMENT 10/20/97: For PRAM-1, Step 2:
• • Viral load \>= 10,000 and \< 100,000 copies/ml at week 12, 24, or 36 in children initially assigned to Arm I (ZDV + 3TC) of PRAM-1 and currently on study.
• Prior Medication:
• Required:
• • Patients must have received continuous antiretroviral therapy for the past 16 weeks.
• Allowed:
• • Patients who have received immunomodulator therapy as part of perinatal clinical trials or in trials for HIV- exposed infants are eligible.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Current grade 3/4 clinical or laboratory toxicity and/or current grade 2 or higher amylase/lipase toxicity.
• • Active opportunistic infection and/or serious bacterial infection.
• • Current diagnosis of malignancy.
• Concurrent Medication:
• Excluded:
• * Current antiretroviral therapy identical to any of the following regimens:
• • ZDV + 3TC, d4T + ritonavir and ZDV + 3TC + ritonavir.
• • Concurrent therapy with any other anti-HIV-1 therapy, biologic response modifiers (EPO, G-CSF and GM-CSF allowed), human growth hormone and megestrol acetate.
• • Use of continuous systemic corticosteroids (\>= 14 days duration) is not allowed.
• • Medications that are incompatible with ritonavir.
• • Probenecid and daily intravenous pentamidine.
• \[AS PER AMENDMENT 10/23/98: The following are excluded in patients receiving indinavir:
• • terfenadine, astemizole, cisapride, rifampin, rifabutin, triazolam, ketoconazole, clarithromycin, carbamazepine, phenobarbital, phenytoin, calcium channel blockers, midazolam, and ergot derivatives.\]
• Patients with the following prior conditions and symptoms are excluded:
• • Documented hypersensitivity to a therapy included in any of the treatment arms.
• Prior Medication:
• Excluded:
• • Investigational drug therapy within 2 weeks prior to randomization.
• NOTE:
• • Co-enrollment in ACTG 219, ACTG 220 and certain ACTG opportunistic infection protocols is allowed.