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AzTrials

HIV InfectionsPhase 1NCT00038480

Safety and Effectiveness of Lopinavir/Ritonavir in HIV Infected Infants

A Phase 1 study testing Lopinavir/Ritonavir in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 17 sites in 3 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 find out if the drug lopinavir/ritonavir (LPV/RTV) is safe and well tolerated in HIV infected infants. This study will also determine the most effective dose of LPV/RTV for infants. Read more about this study

Who is it for?
Ages 14 days to 6 months
Conditions the study is for
HIV Infections
What is being tested?
Lopinavir/Ritonavir
How many people
31 participants
Where
17 sitesin 3 countries
Study dates
Start not givento Sep 2007
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 14 days to 6 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • HIV infected
  • Viral load greater than 10,000 copies/ml within 30 days prior to study entry
  • Weigh more than 5.5 lbs at the time of enrollment
  • Agree to take 2 nucleoside reverse transcriptase inhibitors (NRTIs) in addition to LPV/RTV
  • Have consent of parent or guardian willing to provide signed informed consent and to have the infant followed at a PACTG site

Who cannot join

  • Currently taking a nonnucleoside reverse transcriptase inhibitor or protease inhibitor (PI) while on study
  • Previously used LPV/RTV. Patients who were treated previously with other PIs are not excluded. Prior or concurrent maternal treatment with LPV/RTV is not excluded.
  • For patients less than 6 weeks old at time of enrollment, less than 34 weeks gestation at delivery OR for patients 6 or more weeks old at time of enrollment, less than 32 weeks gestation at delivery
  • Any laboratory toxicity of Grade 3 or greater. Hyperlipasemia of Grade 2 or higher is also excluded.
  • Newly diagnosed acute opportunistic or serious bacterial infection requiring therapy at the time of enrollment
  • Chemotherapy for active cancer
  • Certain medications
  • Any other clinically significant conditions, other than HIV infection, that would interfere with the study

Trial locations and contacts

17 sites in 3 countries.

17 sites in 3 countries

United States14 sites

  • Univ. of Colorado Denver NICHD CRS

    Aurora, Colorado, 80218-1088

  • Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology

    Baltimore, Maryland, 21201

  • Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases

    Baltimore, Maryland, 21287

  • Children's Hosp. of Boston NICHD CRS

    Boston, Massachusetts, 021155724

  • Chicago Children's CRS

    Chicago, Illinois, 606143394

  • Univ. of Florida Jacksonville NICHD CRS

    Jacksonville, Florida, 32209

  • St. Jude/UTHSC CRS

    Memphis, Tennessee, 381052794

  • Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.

    Oakland, California, 94609-1809

  • St. Christopher's Hosp. for Children

    Philadelphia, Pennsylvania

  • UCSF Pediatric AIDS CRS

    San Francisco, California, 94143-0105

  • Baystate Health, Baystate Med. Ctr.

    Springfield, Massachusetts, 01199

  • USF - Tampa NICHD CRS

    Tampa, Florida

  • Bronx-Lebanon Hosp. IMPAACT CRS

    The Bronx, New York, 10457

  • Children's National Med. Ctr. Washington DC NICHD CRS

    Washington D.C., District of Columbia

Other trials in United States

Brazil2 sites

  • SOM Federal University Minas Gerais Brazil NICHD CRS

    Minas Gerais

  • Univ. of Sao Paulo Brazil NICHD CRS

    São Paulo

Other trials in Brazil

Puerto Rico1 site

  • San Juan City Hosp. PR NICHD CRS

    San Juan

Other trials in Puerto Rico

About this study

Official title: A Phase I/II Study of Lopinavir/Ritonavir in HIV-1 Infected Infants Less Than 6 Months of Age

The purpose of this study is to find out if the drug lopinavir/ritonavir (LPV/RTV) is safe and well tolerated in HIV infected infants. This study will also determine the most effective dose of LPV/RTV for infants.

Read the detailed description

LPV/RTV has shown significant antiviral activity and tolerability in clinical trials in adults and children over 6 months of age. LPV/RTV has been approved by the FDA to treat older children and adults with HIV. Data for children under 6 months, however, have not been available. LPV/RTV has not been approved for infants less than 6 months old, and the appropriate dose for young infants is not known. Dosing guidelines are needed for young infants, most of whom are in the early stages of primary infection. This study will help identify an appropriate dose range of LPV/RTV and evaluate response to therapy in infants less than 6 months of age. The study will also evaluate whether early therapy allows normal development of the immune system.

Infants between 14 days and 6 months of age will receive LPV/RTV in combination with 2 nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their physicians. Twelve-hour pharmacokinetic sampling is performed on Day 14 of drug treatment and when the patient reaches 12 months of age. Patients will undergo a physical exam, medical history assessment, and blood collection at selected study visits. Study visits will occur every 2 weeks for the first 8 weeks, then every 4 weeks until the end of the first year of the study. Study visits during the second year will be every 12 weeks until the end of the study. The parent or guardian will be contacted by phone every 6 weeks to monitor adverse drug effects. Participants between the ages of 6 weeks but less than 6 months old will be followed for 96 weeks after the enrollment of the last participant. Participants between the ages of 14 weeks but less than 6 weeks will be followed for 48 weeks after the enrollment of the last participant.

Conditions
HIV Infections
Being tested
Lopinavir/Ritonavir
Keywords
Lopinavir, HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, 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.

  • Lopinavir/RitonavirDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Trough concentration of LPV and pharmacokinetic parameters

    Measured: Weeks 8, 16, 24, 36, 48, 60, 72, 84, and 96

  2. Recurrent treatment-related Grade 3 and non-life threatening Grade 4 toxicity or single occurence of life-threatening Grade 4 toxicity

    Measured: Throughout study

Secondary outcomes (3)

  1. Change in CD4 and CD8 count and percentage from baseline. HIV-1 specific CD4 count and CD8 mediated and humoral responses

    Measured: Study entry and Weeks 12, 24, 36, 48, 60, 72, 84, and 96

  2. Time to virologic failure

    Measured: Throughout study

  3. Suppression of viral load to less than 400 copies/ml and less than 50 copies/ml

    Measured: Study entry and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 36, 40, 48, 60, 72, 84, and 96

Timeline

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

  1. First posted3 Jun 2002 (estimated)
  2. Study completionSep 2007

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
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00038480
Sponsor's protocol ID
P1030
Other IDs
10041, PACTG P1030
Status last verified
Oct 2021
First submitted
31 May 2002
Last updated
1 Nov 2021
Results posted
No

Publications

  • Luzuriaga K, Wu H, McManus M, Britto P, Borkowsky W, Burchett S, Smith B, Mofenson L, Sullivan JL. Dynamics of human immunodeficiency virus type 1 replication in vertically infected infants. J Virol. 1999 Jan;73(1):362-7. doi: 10.1128/JVI.73.1.362-367.1999.

    PubMed 9847340

  • Equils O, Garratty E, Wei LS, Plaeger S, Tapia M, Deville J, Krogstad P, Sim MS, Nielsen K, Bryson YJ. Recovery of replication-competent virus from CD4 T cell reservoirs and change in coreceptor use in human immunodeficiency virus type 1-infected children responding to highly active antiretroviral therapy. J Infect Dis. 2000 Sep;182(3):751-7. doi: 10.1086/315758. Epub 2000 Aug 15.

    PubMed 10950768

  • Luzuriaga K, McManus M, Catalina M, Mayack S, Sharkey M, Stevenson M, Sullivan JL. Early therapy of vertical human immunodeficiency virus type 1 (HIV-1) infection: control of viral replication and absence of persistent HIV-1-specific immune responses. J Virol. 2000 Aug;74(15):6984-91. doi: 10.1128/jvi.74.15.6984-6991.2000.

    PubMed 10888637

  • Saez-Llorens X, Violari A, Deetz CO, Rode RA, Gomez P, Handelsman E, Pelton S, Ramilo O, Cahn P, Chadwick E, Allen U, Arpadi S, Castrejon MM, Heuser RS, Kempf DJ, Bertz RJ, Hsu AF, Bernstein B, Renz CL, Sun E. Forty-eight-week evaluation of lopinavir/ritonavir, a new protease inhibitor, in human immunodeficiency virus-infected children. Pediatr Infect Dis J. 2003 Mar;22(3):216-24. doi: 10.1097/01.inf.0000055061.97567.34.

    PubMed 12634581

  • Chadwick EG, Pinto J, Yogev R, Alvero CG, Hughes MD, Palumbo P, Robbins B, Hazra R, Serchuck L, Heckman BE, Purdue L, Browning R, Luzuriaga K, Rodman J, Capparelli E; International Maternal Pediatric Adolescent Clinical Trials Group (IMPAACT) P1030 Team. Early initiation of lopinavir/ritonavir in infants less than 6 weeks of age: pharmacokinetics and 24-week safety and efficacy. Pediatr Infect Dis J. 2009 Mar;28(3):215-9. doi: 10.1097/INF.0b013e31818cc053.

    PubMed 19209098

  • Chadwick EG, Yogev R, Alvero CG, Hughes MD, Hazra R, Pinto JA, Robbins BL, Heckman BE, Palumbo PE, Capparelli EV; International Pediatric Adolescent Clinical Trials Group (IMPAACT) P1030 Team. Long-term outcomes for HIV-infected infants less than 6 months of age at initiation of lopinavir/ritonavir combination antiretroviral therapy. AIDS. 2011 Mar 13;25(5):643-9. doi: 10.1097/QAD.0b013e32834403f6.

    PubMed 21297419

  • Persaud D, Palumbo PE, Ziemniak C, Hughes MD, Alvero CG, Luzuriaga K, Yogev R, Capparelli EV, Chadwick EG. Dynamics of the resting CD4(+) T-cell latent HIV reservoir in infants initiating HAART less than 6 months of age. AIDS. 2012 Jul 31;26(12):1483-90. doi: 10.1097/QAD.0b013e3283553638.

    PubMed 22555165

  • Persaud D, Palumbo P, Ziemniak C, Chen J, Ray SC, Hughes M, Havens P, Purswani M, Gaur AH, Chadwick EG; Pediatric AIDS Clinical Trials Group P1030 Team. Early archiving and predominance of nonnucleoside reverse transcriptase inhibitor-resistant HIV-1 among recently infected infants born in the United States. J Infect Dis. 2007 May 15;195(10):1402-10. doi: 10.1086/513871. Epub 2007 Apr 5.

    PubMed 17436219

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lopinavir/Ritonavir in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 17 sites in 3 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 5 inclusion and 8 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 1 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 17 sites in United States, Brazil, 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.

What does the primary outcome measure?

Trough concentration of LPV and pharmacokinetic parameters (time frame: Weeks 8, 16, 24, 36, 48, 60, 72, 84, and 96). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00038480, which also lists 8 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 1 Nov 2021.

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