Search / Trial NCT00001083

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

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Trial Information

Current as of November 28, 2023

Completed

Keywords

Hiv 1 Drug Therapy, Combination Zidovudine Nevirapine Stavudine Hiv Protease Inhibitors Ritonavir Lamivudine Indinavir Rna, Viral Reverse Transcriptase Inhibitors Anti Hiv Agents

Description

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.

Attachments

readout_NCT00001083_2023-11-28.pdf

4.5 MB

NCT00001083_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Los Angeles, California, United States

Springfield, Massachusetts, United States

Seattle, Washington, United States

Bronx, New York, United States

La Jolla, California, United States

Long Beach, California, United States

Los Angeles, California, United States

Los Angeles, California, United States

Oakland, California, United States

San Francisco, California, United States

New Haven, Connecticut, United States

Washington, District Of Columbia, United States

Washington, District Of Columbia, United States

Miami, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

New Brunswick, New Jersey, United States

Newark, New Jersey, United States

Albany, New York, United States

Brooklyn, New York, United States

Brooklyn, New York, United States

Great Neck, New York, United States

New Hyde Park, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Stony Brook, New York, United States

Syracuse, New York, United States

Valhalla, New York, United States

Durham, North Carolina, United States

Columbus, Ohio, United States

Philadelphia, Pennsylvania, United States

Charleston, South Carolina, United States

Dallas, Texas, United States

Houston, Texas, United States

Bayamon, , Puerto Rico

San Juan, , Puerto Rico

San Juan, , Puerto Rico

Newark, New Jersey, United States

Bronx, New York, United States

Los Angeles, California, United States

Farmington, Connecticut, United States

New Orleans, Louisiana, United States

Worcester, Massachusetts, United States

Jacksonville, Florida, United States

Rochester, New York, United States

Birmingham, Alabama, United States

Fort Lauderdale, Florida, United States

Gainesville, Florida, United States

Riviera Beach, Florida, United States

Jackson, Mississippi, United States

Richmond, Virginia, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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