HIV InfectionsPhase 4NCT00626301
Lopinavir/Ritonavir Monotherapy in Children
A Phase 4 study testing LPV/r in people with HIV Infections, run by The HIV Netherlands Australia Thailand Research Collaboration at 3 sites in Thailand.
Trial summary
The purpose of this study is to evaluate the efficacy (clinical, immunological, virological outcome), pharmacokinetics and safety of lopinavir/ritonavir (LPV/r) monotherapy maintenance in Thai children after viral load suppression with double boosted protease inhibitors (PIs). Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- LPV/r
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesThailand
- Study dates
- Nov 2007to Sep 2009
- Phase
- Phase 4
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- HIV infected children ages 2 to 18 years
- Treated with double boosted PIs during the last three months
- Two consecutive plasma HIV-RNA levels < 50 copies/ml at least 3 months apart
- Willing to restart HAART with the same regimen as before enrollment, when indicated
- Signed written informed consent
Who cannot join
- Active AIDS-defining disease at screening
- Pregnancy
Trial locations and contacts
3 sites in 1 country.
Thailand3 sites
Department of Pediatrics, Chulalongkorn University Hospital
Bangkok, Bangkok, 10330
HIV-NAT
Bangkok, Bangkok, 10330
Department of Pediatrics, Khon Kaen University
Khon Kaen, Changwat Khon Kaen
About this study
Official title: Simplifying Antiretroviral Treatment in Virally Suppressed Children by Switching From Double Boosted Protease Inhibitors to Lopinavir/Ritonavir Monotherapy
The purpose of this study is to evaluate the efficacy (clinical, immunological, virological outcome), pharmacokinetics and safety of lopinavir/ritonavir (LPV/r) monotherapy maintenance in Thai children after viral load suppression with double boosted protease inhibitors (PIs).
Read the detailed description
The commonly used antiretroviral (ARV) regimen in the Thai National Access to Antiretroviral Program for People Living with HIV/AIDS is non-nucleoside reverse transcriptase (NNRTI) based HAART. However, one of the most challenging concerns of antiretroviral therapy is the emergence of drug resistance mutants which occurs in 30-40% of treated patients. Children failing nucleoside reverse transcriptase inhibitor (NRTI)/NNRTI regimens have limited options for second line therapy especially in a developing country such as Thailand.
At HIV-NAT, the Thai Red Cross AIDS Research Centre, we had a trial using standard doses of double boosted PIs, Lopinavir/ritonavir and Saquinavir, HIV-NAT 017, in 50 HIV infected children who failed the first line regimen. This ongoing trial showed the good efficacy of the double boosted PI in children, significant increasing of CD4 and decreasing of HIV-RNA in children who adhered to the treatment. However, a high number of pill counts for this regimen, 5-8 pills every 12 hours, life long can affect adherence and treatment outcome. In the HIV-NAT 017 study, a 48 week intent to treat analysis, 38% and 50% of children had total cholesterol ≥ 200 mg/dl and triglycerides ≥ 150 mg/dl after double boosted PI. Those lipid levels were significantly elevated when compared to baseline (p < 0.001). Double boosted PIs are also very costly. Studies in adults have shown that double boosted PIs had a disadvantage in lipid effect compared to a single PI-based regimen.
Lopinavir/ritonavir, the only PI co-formulated with ritonavir, is recommended as a first-line option for antiretroviral-naive patients initiating PI-based therapy and has shown a high potency, efficacy, and safety in HIV patients with high genetic barriers to resistance. LPV/r has also shown excellent efficacy in ARV-experienced children.
Mono boosted PI therapy trials in HIV adults, as the maintenance therapy after suppressed viral load, have been shown to be effective and safe. This strategy not only decreases the number of pills per dose but also saves for ARV cost and might improve the patient's adherence. As maintenance monotherapy after HIV-1 viral suppression, lopinavir/ritonavir has shown efficacy in adult trials with 80-90% virological suppression. A pilot study of a switch to lopinavir/ritonavir (LPV/r) monotherapy from nonnucleoside reverse transcriptase inhibitor-based therapy was reported with 92% of the participants on treatment at week 48 having HIV RNA < 75 copies/mL.
Therefore, in this trial, we aim to see the efficacy and safety of lopinavir/ritonavir maintenance monotherapy in Thai HIV infected children after virological suppression from previous double boosted PIs.
By simplifying maintenance antiretroviral treatment in children who are virally suppressed from previous double boosted PIs to lopinavir/ritonavir monotherapy, we hope to achieve the following:
- A decrease in total cholesterol, LDL and triglycerides
- An improvement in quality of life and in adherence to ARVs
- No change in viral load
- Conditions
- HIV Infections
- Being tested
- LPV/r
- Keywords
- efficacy, safety, pharmacokinetics, LPV/r monotherapy, Thai children, efficacy safety LPV/r monotherapy maintenance, treatment experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPV/rDrug
LPV/r 230/57.5 mg/m2 orally q12h or the adjusted dose based on therapeutic drug monitoring of LPV/r prior to enrollment as maintenance monotherapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Children who have completed HIV-NAT 017. Children treated with other double boosted PIs such as indinavir plus lopinavir/ ritonavir are also included. Receives: Drug: LPV/r |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate efficacy (clinical, immunological, virological outcome), pharmacokinetics and safety of LPV/r monotherapy maintenance in Thai children after viral load suppression with double boosted PIs
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startNov 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- Chulalongkorn University, Khon Kaen University
- Responsible party
- Sponsor
- Investigators
- Praphan Phanuphak, MD, PhD, Principal investigator, Thai Red Cross AIDS Research CentrePope Kosalaraksa, MD, Principal investigator, Department of Pediatrics, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626301
- Sponsor's protocol ID
- HIV-NAT 077
- Other IDs
- IRB# 241/50
- Status last verified
- Mar 2015
- First submitted
- 21 Feb 2008
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bunupuradah T, Panthong A, Kosalaraksa P, Wongsabut J, Puthanakit T, Lumbiganon P, Chuanjaroen T, Sopharak C, Udompanit T, Prasitsuebsai W, Pancharoen C, Ananworanich J; HIV-NAT 077 Study Team. Simplifying antiretroviral therapy to lopinavir/ritonavir monotherapy did not improve quality of life and therapy adherence in pretreated HIV-infected children. AIDS Res Hum Retroviruses. 2014 Mar;30(3):260-5. doi: 10.1089/AID.2013.0204. Epub 2013 Dec 21.
PubMed 24274723Kosalaraksa P, Ananworanich J, Puthanakit T, Pinyakorn S, Lumbiganon P, Chuanjaroen T, Chobkarjing U, Phanuphak P, Pancharoen C, Bunupuradah T; HIV-NAT 077 Study Team. Long-term lopinavir/ritonavir monotherapy in HIV-infected children. Pediatr Infect Dis J. 2013 Apr;32(4):350-3. doi: 10.1097/INF.0b013e31827b1bd3.
PubMed 23190774Bunupuradah T, Kosalaraksa P, Puthanakit T, Mengthaisong T, Wongsabut J, Lumbiganon P, Phanuphak P, Burger D, Pancharoen C, Ananworanich J; HIV-NAT 077 Study Team. Monoboosted lopinavir/ritonavir as simplified second-line maintenance therapy in virologically suppressed children. AIDS. 2011 Jan 28;25(3):315-23. doi: 10.1097/QAD.0b013e32834231f5.
PubMed 21157298
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplifying Antiretroviral Treatment in Virally Suppressed Children by Switching From Double Boosted Protease Inhibitors to Lopinavir/Ritonavir Monotherapy
- ClinicalTrials.gov ID
- NCT00626301
- Acronym / sponsor ID
- HIV-NAT 077
- Conditions
- HIV Infections
- Keywords
- efficacy, safety, pharmacokinetics, LPV/r monotherapy, Thai children, efficacy safety LPV/r monotherapy maintenance, treatment experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- Chulalongkorn University, Khon Kaen University
- Study start
- Nov 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 29 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy (clinical, immunological, virological outcome), pharmacokinetics and safety of lopinavir/ritonavir (LPV/r) monotherapy maintenance in Thai children after viral load suppression with double boosted protease inhibitors (PIs).
Detailed description
The commonly used antiretroviral (ARV) regimen in the Thai National Access to Antiretroviral Program for People Living with HIV/AIDS is non-nucleoside reverse transcriptase (NNRTI) based HAART. However, one of the most challenging concerns of antiretroviral therapy is the emergence of drug resistance mutants which occurs in 30-40% of treated patients. Children failing nucleoside reverse transcriptase inhibitor (NRTI)/NNRTI regimens have limited options for second line therapy especially in a developing country such as Thailand.
At HIV-NAT, the Thai Red Cross AIDS Research Centre, we had a trial using standard doses of double boosted PIs, Lopinavir/ritonavir and Saquinavir, HIV-NAT 017, in 50 HIV infected children who failed the first line regimen. This ongoing trial showed the good efficacy of the double boosted PI in children, significant increasing of CD4 and decreasing of HIV-RNA in children who adhered to the treatment. However, a high number of pill counts for this regimen, 5-8 pills every 12 hours, life long can affect adherence and treatment outcome. In the HIV-NAT 017 study, a 48 week intent to treat analysis, 38% and 50% of children had total cholesterol ≥ 200 mg/dl and triglycerides ≥ 150 mg/dl after double boosted PI. Those lipid levels were significantly elevated when compared to baseline (p < 0.001). Double boosted PIs are also very costly. Studies in adults have shown that double boosted PIs had a disadvantage in lipid effect compared to a single PI-based regimen.
Lopinavir/ritonavir, the only PI co-formulated with ritonavir, is recommended as a first-line option for antiretroviral-naive patients initiating PI-based therapy and has shown a high potency, efficacy, and safety in HIV patients with high genetic barriers to resistance. LPV/r has also shown excellent efficacy in ARV-experienced children.
Mono boosted PI therapy trials in HIV adults, as the maintenance therapy after suppressed viral load, have been shown to be effective and safe. This strategy not only decreases the number of pills per dose but also saves for ARV cost and might improve the patient's adherence. As maintenance monotherapy after HIV-1 viral suppression, lopinavir/ritonavir has shown efficacy in adult trials with 80-90% virological suppression. A pilot study of a switch to lopinavir/ritonavir (LPV/r) monotherapy from nonnucleoside reverse transcriptase inhibitor-based therapy was reported with 92% of the participants on treatment at week 48 having HIV RNA < 75 copies/mL.
Therefore, in this trial, we aim to see the efficacy and safety of lopinavir/ritonavir maintenance monotherapy in Thai HIV infected children after virological suppression from previous double boosted PIs.
By simplifying maintenance antiretroviral treatment in children who are virally suppressed from previous double boosted PIs to lopinavir/ritonavir monotherapy, we hope to achieve the following:
- A decrease in total cholesterol, LDL and triglycerides
- An improvement in quality of life and in adherence to ARVs
- No change in viral load
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: LPV/rChildren who have completed HIV-NAT 017. Children treated with other double boosted PIs such as indinavir plus lopinavir/ ritonavir are also included. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- HIV infected children ages 2 to 18 years
- Treated with double boosted PIs during the last three months
- Two consecutive plasma HIV-RNA levels < 50 copies/ml at least 3 months apart
- Willing to restart HAART with the same regimen as before enrollment, when indicated
- Signed written informed consent
Key exclusion criteria (2 listed)
- Active AIDS-defining disease at screening
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LPV/rLPV/r 230/57.5 mg/m2 orally q12h or the adjusted dose based on therapeutic drug monitoring of LPV/r prior to enrollment as maintenance monotherapy | Drug | 1 |
Primary outcome
To evaluate efficacy (clinical, immunological, virological outcome), pharmacokinetics and safety of LPV/r monotherapy maintenance in Thai children after viral load suppression with double boosted PIs
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
- Results publication: PubMed 24274723Bunupuradah T, Panthong A, Kosalaraksa P, Wongsabut J, Puthanakit T, Lumbiganon P, Chuanjaroen T, Sopharak C, Udompanit T, Prasitsuebsai W, Pancharoen C, Ananworanich J; HIV-NAT 077 Study Team. Simplifying antiretroviral therapy to lopinavir/ritonavir monotherapy did not improve quality of life and therapy adherence in pretreated HIV-infected children. AIDS Res Hum Retroviruses. 2014 Mar;30(3):260-5. doi: 10.1089/AID.2013.0204. Epub 2013 Dec 21.
- Results publication: PubMed 23190774Kosalaraksa P, Ananworanich J, Puthanakit T, Pinyakorn S, Lumbiganon P, Chuanjaroen T, Chobkarjing U, Phanuphak P, Pancharoen C, Bunupuradah T; HIV-NAT 077 Study Team. Long-term lopinavir/ritonavir monotherapy in HIV-infected children. Pediatr Infect Dis J. 2013 Apr;32(4):350-3. doi: 10.1097/INF.0b013e31827b1bd3.
- Results publication: PubMed 21157298Bunupuradah T, Kosalaraksa P, Puthanakit T, Mengthaisong T, Wongsabut J, Lumbiganon P, Phanuphak P, Burger D, Pancharoen C, Ananworanich J; HIV-NAT 077 Study Team. Monoboosted lopinavir/ritonavir as simplified second-line maintenance therapy in virologically suppressed children. AIDS. 2011 Jan 28;25(3):315-23. doi: 10.1097/QAD.0b013e32834231f5.
- The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Praphan Phanuphak, MD, PhD principal investigator
Thai Red Cross AIDS Research Centre
Pope Kosalaraksa, MD principal investigator
Department of Pediatrics, Khon Kaen University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LPV/r in people with HIV Infections, run by The HIV Netherlands Australia Thailand Research Collaboration at 3 sites in Thailand.
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 2 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 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Thailand. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
To evaluate efficacy (clinical, immunological, virological outcome), pharmacokinetics and safety of LPV/r monotherapy maintenance in Thai children after viral load suppression with double boosted PIs (time frame: 48 weeks). 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 NCT00626301, which also lists 3 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 26 Mar 2015.