NCT02346487

Brief Summary

The study will be carried out to provide supportive clinical data on the feasibility, efficacy, safety, and PK of LPV based therapies in routine treatment setting and will be based on the existing LPV/r pellets which already represent a clear advantage in comparison with the liquid formulation.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,003

participants targeted

Target at P75+ for phase_3 hiv

Timeline
Completed

Started Sep 2015

Typical duration for phase_3 hiv

Geographic Reach
3 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2019

Completed
Last Updated

May 20, 2019

Status Verified

May 1, 2019

Enrollment Period

3.7 years

First QC Date

January 13, 2015

Last Update Submit

May 17, 2019

Conditions

HIV

Keywords

children

Outcome Measures

Primary Outcomes (1)

  • Treatment effectiveness at 48 weeks based on a composite endpoint of: i) virologic response <1000 copies/ml ii) being alive and iii) on study drug

    • Treatment effectiveness at 48 weeks based on a composite endpoint of: i) virologic response \<1000 copies/ml ii) being alive and iii) on study drug

    48 weeks

Secondary Outcomes (6)

  • Treatment effectiveness based on virologic, immunologic and clinical endpoints

    96 weeks

  • Rate of AEs/SAEs as measure of safety

    96 weeks

  • Pharmacokinetics - Plasma AUC

    96 weeks

  • Feasibility and acceptability questionnaires

    96 weeks

  • Pharmacokinetics - Tmax

    96 weeks

  • +1 more secondary outcomes

Study Arms (1)

LPV/RTV pellets and AZT/3TC or ABC/3TC

EXPERIMENTAL

Only 1 arm. No comparator

Drug: LPV/RTV pellets and AZT/3TC or ABC/3TC

Interventions

LPV/RTV pellets and AZT/3TC or ABC/3TCDRUG

Drug: LPV/r pellets 40/10 mg: orally taken twice a day. Dosage according to patient's weight: * Between 3 and 5.9kg: 2 capsules twice a day * Between 6 and 9.9kg: 3 capsules twice a day * Between 10 and 13.9kg: 4 capsules twice a day * Between 14 and 19.9kg: 5 capsules twice a day * Between 20 and 24.9kg: 6 capsules twice a day Drug: NRTIs (AZT/3TC 60/30mg tablet or ABC/3TC 60/30mg tablet). Dosage according to patient's weight: * Between 3 and 5.9kg: 1 tablet twice a day * Between 6 and 9.9kg: 1.5 tablets twice a day * Between 10 and 13.9kg: 2 tablets twice a day * Between 14 and 19.9kg: 2.5 tablets twice a day * Between 20 and 24.9kg: 3 tablets twice a day

LPV/RTV pellets and AZT/3TC or ABC/3TC

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Past or current documentation of a confirmed diagnosis of HIV infection defined as two positive assays from two different samples taken at a different date as preferred option.
  • At any age: HIV-1 DNA PCR positivity
  • At any time \>4 weeks of age: HIV-1 p24 antigen detection or HIV-1 RNA viral load \> 5,000 copies/mL plasma
  • At any age \>18 months: HIV-1 antibody reactive on two different manufacturers' licensed rapid tests based on a different antigen preparation and/or different test principal, or repeatedly reactive on a licensed enzyme immune assay (EIA)and confirmed on a second sample by any one of the following assays: rapid test (a third manufacturer), licensed EIA, Western blot, chemi-luminescence assay, or plasma RNA with a viral load \> 5,000 copies/mL
  • In case the test is RNA PCR viral load), the sample should be taken before treatment initiation and analyzed as soon as possible thereafter,
  • In case the child is already on treatment, the test should be DNA PCR based, the blood sample can be taken while on treatment and the results be made available as soon as possible.
  • ARV treatment eligible children with LPV-based treatment indication\* as defined by country-specific guidelines or the WHO pediatric treatment guidelines confirmed by investigator:
  • ARV naïve, or
  • Already on first line liquid lopinavir based treatment, or
  • Failing first line NNRTI based therapy
  • Weight ≥3 and \<25 kg at the time of enrolment.
  • Inability to swallow tablets\*

You may not qualify if:

  • Planned or concurrent use of NNRTIs, integrase inhibitors, entry inhibitors, or PIs other than LPV/r.
  • PIs treatment failure with the presence or strong suspicion of a PI resistance mutation.
  • Clinical condition requiring the use of a prohibited medication in association with LPV/r
  • Any clinically significant disease or finding during screening that, in the investigator's opinion, would compromise participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

AMPATH - Moi Teaching and Referral Hospital

Eldoret, Kenya

Location

FACES Lumumba Clinic

Kisumu, Kenya

Location

Gertrude's Children Hospital

Nairobi, Kenya

Location

Kenyatta National Hospital

Nairobi, Kenya

Location

Management and Development for Health(MDH) , at Temeke and Amana Hospitals

Dar es Salaam, Tanzania

Location

Ifakara health Institute

Morogoro, Tanzania

Location

Joint Clinical research Centre

Fort Portal, Uganda

Location

Joint Clinical Research Centre

Gulu, Uganda

Location

Baylor College of Medicine, Children's Foundation - Uganda

Kampala, Uganda

Location

Joint Clinical research Centre

Kampala, Uganda

Location

Epicentre Mbarara Research Centre

Mbarara, Uganda

Location

Related Publications (1)

  • Chupradit S, Wamalwa DC, Maleche-Obimbo E, Kekitiinwa AR, Mwanga-Amumpaire J, Bukusi EA, Nyandiko WM, Mbuthia JK, Swanson A; DNDi Clinical Team; Cressey TR, Punyawudho B, Musiime V; LIVING Study Team. Population Pharmacokinetics of Pediatric Lopinavir/Ritonavir Oral Pellets in Children Living with HIV in Africa. Clin Pharmacol Ther. 2024 May;115(5):1105-1113. doi: 10.1002/cpt.3174. Epub 2024 Jan 21.

    PMID: 38247190DERIVED

Study Officials

  • Dalton Wamalwa, MD

    University of Nairobi, P.O Box 19676 00202 Nairobi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 27, 2015

Study Start

September 1, 2015

Primary Completion

May 14, 2019

Study Completion

May 14, 2019

Last Updated

May 20, 2019

Record last verified: 2019-05

Locations

UG(5)TA(2)KE(4)