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HIV InfectionsPhase 1NCT00001091

Safety and Effectiveness of Four Anti-HIV Drug Combinations in HIV-Infected Children and Teens

A Phase 1 study testing Ritonavir, Nelfinavir mesylate and Nevirapine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 55 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to see if it is safe and effective to give HIV-infected children and teens 1 of 4 anti-HIV drug combinations. Decreasing HIV levels in infected patients can slow down disease progression. Further study is needed to find out which drug combinations are most effective in doing this. Read more about this study

Who is it for?
Ages 4 months to 17 years
Conditions the study is for
HIV Infections
What is being tested?
Ritonavir, Nelfinavir mesylate and Nevirapine
How many people
200 participants
Where
55 sitesin 2 countries
Study dates
Start not givento Oct 2000
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 months to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Patients may be eligible for this study if they:
  • Are HIV-positive.
  • Have received the same continuous anti-HIV treatment for the past 16 weeks (missing no more than 6 weeks of treatment total during those 16 weeks).
  • Are between 4 months and 17 years old (consent of parent or guardian required).

Who cannot join

  • Patients will not be eligible if they:
  • Have certain serious conditions such as cancer, an opportunistic (AIDS-related) infection, or other serious infection.
  • Have ever taken any of the study drugs or any protease inhibitor.
  • Are currently taking any anti-HIV drugs.
  • Have taken an investigational drug within 14 days of entry into the study. (Co-enrollment in ACTG 219, ACTG 220 and certain ACTG opportunistic infection studies is allowed.)
  • Are taking certain other drugs.
  • Are pregnant.

Trial locations and contacts

55 sites in 2 countries.

55 sites in 2 countries

United States53 sites

  • Emory Univ Hosp / Pediatrics

    Atlanta, Georgia, 30306

  • Med College of Georgia

    Augusta, Georgia, 30912

  • Univ of Maryland at Baltimore / Univ Med Ctr

    Baltimore, Maryland, 21201

  • Johns Hopkins Hosp - Pediatric

    Baltimore, Maryland, 212874933

  • Univ of Alabama at Birmingham - Pediatric

    Birmingham, Alabama, 35233

  • King's County Hosp Ctr / Pediatrics

    Brooklyn, New York, 11203

  • SUNY - Brooklyn

    Brooklyn, New York, 11203

  • Med Univ of South Carolina

    Charleston, South Carolina, 294253312

  • Cook County Hosp

    Chicago, Illinois, 60612

  • Univ of Illinois College of Medicine / Pediatrics

    Chicago, Illinois, 60612

  • Chicago Children's Memorial Hosp

    Chicago, Illinois, 606143394

  • Univ of Chicago Children's Hosp

    Chicago, Illinois, 606371470

  • North Broward Hosp District

    Fort Lauderdale, Florida, 33311

  • Univ of Florida Gainesville

    Gainesville, Florida, 32610

  • North Shore Univ Hosp

    Great Neck, New York, 11021

  • Connecticut Children's Med Ctr - Pediatric

    Hartford, Connecticut, 06106

  • Univ of Mississippi Med Ctr

    Jackson, Mississippi, 39213

  • Univ of Florida Health Science Ctr / Pediatrics

    Jacksonville, Florida, 32209

  • UCSD Med Ctr / Pediatrics / Clinical Sciences

    La Jolla, California, 920930672

  • Long Beach Memorial (Pediatric)

    Long Beach, California, 90801

  • Children's Hosp of Los Angeles/UCLA Med Ctr

    Los Angeles, California, 900276016

  • Los Angeles County - USC Med Ctr

    Los Angeles, California, 90033

  • UCLA Med Ctr / Pediatric

    Los Angeles, California, 900951752

  • Harbor - UCLA Med Ctr / UCLA School of Medicine

    Los Angeles, California, 905022004

  • Vanderbilt Univ Med Ctr

    Nashville, Tennessee, 372322581

  • UMDNJ - Robert Wood Johnson Med School / Pediatrics

    New Brunswick, New Jersey, 089030019

  • Yale Univ Med School

    New Haven, Connecticut, 06504

  • Schneider Children's Hosp

    New Hyde Park, New York, 11040

  • Tulane Univ / Charity Hosp of New Orleans

    New Orleans, Louisiana, 701122699

  • Bellevue Hosp / New York Univ Med Ctr

    New York, New York, 10016

  • Cornell Univ Med College

    New York, New York, 10021

  • Metropolitan Hosp Ctr

    New York, New York, 10029

  • Columbia Presbyterian Med Ctr

    New York, New York, 10032

  • Incarnation Children's Ctr / Columbia Presbyterian Med Ctr

    New York, New York, 10032

  • Harlem Hosp Ctr

    New York, New York, 10037

  • Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl

    Newark, New Jersey, 07103

  • Children's Hosp of the King's Daughters

    Norfolk, Virginia, 23507

  • Children's Hosp of Oakland

    Oakland, California, 946091809

  • Children's Hosp of Philadelphia

    Philadelphia, Pennsylvania, 191044318

  • Saint Christopher's Hosp for Children

    Philadelphia, Pennsylvania, 191341095

  • Palm Beach County Health Dept

    Riviera Beach, Florida, 33404

  • Univ of Rochester Med Ctr

    Rochester, New York, 146420001

  • UCSF / Moffitt Hosp - Pediatric

    San Francisco, California, 941430105

  • Children's Hospital & Medical Center / Seattle ACTU

    Seattle, Washington, 981050371

  • Baystate Med Ctr of Springfield

    Springfield, Massachusetts, 01199

  • State Univ of New York at Stony Brook

    Stony Brook, New York, 117948111

  • Bronx Lebanon Hosp Ctr

    The Bronx, New York, 10457

  • Bronx Municipal Hosp Ctr / Bronx Lebanon Hosp Ctr

    The Bronx, New York, 10461

  • Bronx Municipal Hosp Ctr/Jacobi Med Ctr

    The Bronx, New York, 10461

  • Children's Hosp of Washington DC

    Washington D.C., District of Columbia, 200102916

  • Washington Hosp Ctr

    Washington D.C., District of Columbia, 200102931

  • Howard Univ Hosp

    Washington D.C., District of Columbia, 20060

  • Univ of Massachusetts Med School

    Worcester, Massachusetts, 016550001

Other trials in United States

Puerto Rico2 sites

  • Ramon Ruiz Arnau Univ Hosp / Pediatrics

    Bayamón, 00956

  • San Juan City Hosp

    San Juan, 009367344

Other trials in Puerto Rico

About this study

Official title: A Phase II Rolling Arm Master Protocol (PRAM) of Novel Antiretroviral Therapy in Stable Experienced HIV-Infected Children. PRAM-2: A Phase I/II Randomized, Multicenter Protocol Comparing Four Antiretroviral Regimens Containing Combinations of Protease Inhibitors, NRTIs and an NNRTI

The purpose of this study is to see if it is safe and effective to give HIV-infected children and teens 1 of 4 anti-HIV drug combinations.

Decreasing HIV levels in infected patients can slow down disease progression. Further study is needed to find out which drug combinations are most effective in doing this.

Read the detailed description

For PRAM 2: Evidence suggests that as a consequence of antiviral therapy, decreases in plasma HIV-1 RNA are strongly associated with a delay in clinical progression. Therefore, the drug regimens proposed in this study are designed to result in a much larger sustained drop in plasma HIV-1 RNA and greater clinical benefit. Further intent of this study is to evaluate the virologic and therapeutic potential of novel combinations of antiretrovirals and to better define the pharmacokinetics and drug-drug interactions of therapies included in this regimen.

The Master PRAM schema is designed to allow new therapeutic arms to be studied as "rolling screens" through multiple generations of PRAMs. There is a common, "linking" regimen between any 2 sequential PRAM generations that will permit an indirect comparison of included therapies. (NOTE: Due to significant changes in study design between PRAM 1 and PRAM 2, there is no "linking" arm between them. The linkage will be reinstated from PRAM 2 and subsequent PRAM generations.) The therapeutic potential of the treatment arms is assessed by their ability to decrease HIV copy numbers as defined by plasma HIV-1 RNA copy number. Once accrual to a PRAM is complete, a new treatment comparison will open for accrual.

For PRAM 2: This study will compare the following 4 treatment arms:

Arm A - stavudine (d4T)/nevirapine/ritonavir Arm B - d4T/lamivudine (3TC)/nelfinavir Arm C - d4T/nevirapine/nelfinavir Arm D - d4T/3TC/nevirapine/nelfinavir. Prior to randomization to 1 of the PRAM 2 treatment arms, patients are stratified based on their CD4% (less than 25% and greater than or equal to 25%) and by age (less than 24 months and greater than or equal to 24 months). The first 35 subjects/treatment arm are evaluated with special immunologic studies including lymphoproliferative assays and extended panel immunophenotyping. There is an interim analysis after all patients have completed 12 weeks of treatment. Patients are treated for 48 weeks. [AS PER AMENDMENT 6/11/99: The study has been extended for an additional 48 weeks (96 weeks total) to permit long-term follow-up of clinically stable, HIV-infected children.]

Conditions
HIV Infections
Being tested
Ritonavir, Nelfinavir mesylate, Nevirapine, Lamivudine, Stavudine
Keywords
Drug Therapy, Combination, Nevirapine, Stavudine, HIV Protease Inhibitors, Ritonavir, Lamivudine, Nelfinavir, Reverse Transcriptase Inhibitors
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionOct 2000

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Enrolment
200 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00001091
Sponsor's protocol ID
ACTG 377
Other IDs
11338, PACTG 377
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
4 Nov 2021
Results posted
No

Publications

  • Cunningham S, Ank B, Lewis D, Lu W, Wantman M, Dileanis JA, Jackson JB, Palumbo P, Krogstad P, Eshleman SH. Performance of the applied biosystems ViroSeq human immunodeficiency virus type 1 (HIV-1) genotyping system for sequence-based analysis of HIV-1 in pediatric plasma samples. J Clin Microbiol. 2001 Apr;39(4):1254-7. doi: 10.1128/JCM.39.4.1254-1257.2001.

    PubMed 11283037

  • Eshleman SH, Krogstad P, Jackson JB, Lee S, Wang YG, Wei LJ, Cunningham S, Wantman M, Lindquist C, Nachman S, Palumbo P. Analysis of HIV-1 drug resistance in a randomized, controlled trial of a combination of nucleoside analog reverse transcriptase (RT) inhibitors plus nevirapine (NVP), nelfinavir (NFV), or ritonavir (RTV) in stable antiretroviral therapy-experienced HIV-infected children. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 468)

  • Eshleman SH, Krogstad P, Jackson JB, Wang YG, Lee S, Wei LJ, Cunningham S, Wantman M, Wiznia A, Johnson G, Nachman S, Palumbo P. Analysis of human immunodeficiency virus type 1 drug resistance in children receiving nucleoside analogue reverse-transcriptase inhibitors plus nevirapine, nelfinavir, or ritonavir (Pediatric AIDS Clinical Trials Group 377). J Infect Dis. 2001 Jun 15;183(12):1732-8. doi: 10.1086/320728. Epub 2001 May 16.

    PubMed 11372025

  • Krogstad P, Lee S, Johnson G, Stanley K, McNamara J, Moye J, Jackson JB, Aguayo R, Dieudonne A, Khoury M, Mendez H, Nachman S, Wiznia A; Pediatric AIDS Clinical Trials Group 377 Study Team. Nucleoside-analogue reverse-transcriptase inhibitors plus nevirapine, nelfinavir, or ritonavir for pretreated children infected with human immunodeficiency virus type 1. Clin Infect Dis. 2002 Apr 1;34(7):991-1001. doi: 10.1086/338814. Epub 2002 Feb 27.

    PubMed 11880966

  • Van Dyke RB, Lee S, Johnson GM, Wiznia A, Mohan K, Stanley K, Morse EV, Krogstad PA, Nachman S; Pediatric AIDS Clinical Trials Group Adherence Subcommittee Pediatric AIDS Clinical Trials Group 377 Study Team. Reported adherence as a determinant of response to highly active antiretroviral therapy in children who have human immunodeficiency virus infection. Pediatrics. 2002 Apr;109(4):e61. doi: 10.1542/peds.109.4.e61.

    PubMed 11927734

  • Wiznia A, Stanley K, Krogstad P, Johnson G, Lee S, McNamara J, Moye J, Jackson JB, Mendez H, Aguayo R, Dieudonne A, Kovacs A, Bamji M, Abrams E, Rana S, Sever J, Nachman S. Combination nucleoside analog reverse transcriptase inhibitor(s) plus nevirapine, nelfinavir, or ritonavir in stable antiretroviral therapy-experienced HIV-infected children: week 24 results of a randomized controlled trial--PACTG 377. Pediatric AIDS Clinical Trials Group 377 Study Team. AIDS Res Hum Retroviruses. 2000 Aug 10;16(12):1113-21. doi: 10.1089/088922200414956.

    PubMed 10954886

  • Jeremy RJ, Kim S, Nozyce M, Nachman S, McIntosh K, Pelton SI, Yogev R, Wiznia A, Johnson GM, Krogstad P, Stanley K; Pediatric AIDS Clinical Trials Group (PACTG) 338 & 377 Study Teams. Neuropsychological functioning and viral load in stable antiretroviral therapy-experienced HIV-infected children. Pediatrics. 2005 Feb;115(2):380-7. doi: 10.1542/peds.2004-1108.

    PubMed 15687448

  • Rosenblatt HM, Song LY, Nachman SA, Stanley KE, Krogstad PA, Johnson GM, Wiznia AA; Pediatric Aids Clinical Trials Group 377 Study Team. Tetanus immunity after diphtheria, tetanus toxoids, and acellular pertussis vaccination in children with clinically stable HIV infection. J Allergy Clin Immunol. 2005 Sep;116(3):698-703. doi: 10.1016/j.jaci.2005.05.016.

    PubMed 16159645

  • Saitoh A, Sarles E, Capparelli E, Aweeka F, Kovacs A, Burchett SK, Wiznia A, Nachman S, Fenton T, Spector SA. CYP2B6 genetic variants are associated with nevirapine pharmacokinetics and clinical response in HIV-1-infected children. AIDS. 2007 Oct 18;21(16):2191-9. doi: 10.1097/QAD.0b013e3282ef9695.

    PubMed 18090046

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ritonavir, Nelfinavir mesylate and Nevirapine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 55 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00001091, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.

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