HIV InfectionsPhase 4NCT00627055
Second-line Therapy Antiretroviral in Patients Who Failed Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) - Based Regimens
A Phase 4 study testing LPV/r and LPV/r + TDF/FTC or TDF/3TC in people with HIV Infections, run by The HIV Netherlands Australia Thailand Research Collaboration at 10 sites in Thailand.
Trial summary
To evaluate the efficacy and safety at 48 weeks between LPV/r monotherapy and 2 NRTIs + LPV/r therapy in patients failing a standard NNRTI-based treatment regimen. Also, to evaluate the short-term 24-week efficacy and safety of Lopinavir/ritonavir (LPV/r) monotherapy and 2 NRTIs+LPV/r therapy in patients failing a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- LPV/r and LPV/r + TDF/FTC or TDF/3TC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 10 sitesThailand
- Study dates
- May 2008to Nov 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- HIV seropositive.
- Have had NNRTI-based HAART in the past for at least 6 months
- Naïve to protease inhibitors (PIs)
- Plasma HIVRNA ≥ 1000 copies/ml
- Signed written informed consent
Who cannot join
- Active AIDS-defining disease or active opportunistic infection
- Previously treated with PIs
- Pregnancy (negative pregnancy test for women of childbearing potential at screening).
- Documented chronic hepatitis B (HbsAg positive)
- ALT ≥ 200 U/L
- Creatinine clearance < 60 c.c. per min by Cockroft-Gault formula formula
- Use of medication that interfere with the action of LPV/r
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Thailand10 sites
Chulalongkorn University
Bangkok, 10330
Hivnat, Trcarc
Bangkok, 10330
Siriraj Hospital
Bangkok, 10700
Ramathibodi Hospital
Bangkok
Taksin Hospital
Bangkok
Sanpatong Hospital
Chiang Mai
Chiang Rai Regional Hospital
Chiang Rai
Chonburi Hospital
Chon Buri, Changwat Chon Buri
Khon Kaen University
Khon Kaen, 40002
Bamrasnaradura Institute
Nonthaburi, 11000
About this study
Official title: The HIV Second-line Therapy AntiRetroviral Study in Patients Who Failed NNRTI-based Regimens
To evaluate the efficacy and safety at 48 weeks between LPV/r monotherapy and 2 NRTIs + LPV/r therapy in patients failing a standard NNRTI-based treatment regimen. Also, to evaluate the short-term 24-week efficacy and safety of Lopinavir/ritonavir (LPV/r) monotherapy and 2 NRTIs+LPV/r therapy in patients failing a standard NNRTI-based treatment regimen as an interim analyses when 50% of the patients in each arm have reached 24 weeks after randomization. Last, to define risk factors for monotherapy failure in HIV-treated individuals
Hypothesis. The rate of virologic suppression is not inferior in the monotherapy arm.
Read the detailed description
With at least 80,000 HIV-1 infected individuals throughout Thailand currently on generically produced fixed dose combination of d4T/3TC/NVP or GPOvir as a first line national recommendation therapy, we will inevitably face with resistance problem in a large number of patients near future. Therefore a comprehensive investigation into the best second line regimen for these individuals is needed. Given the situation in Thailand where economic burden is a major challenge, the second line regimen will have to offer the greatest possible efficacy, and cost-effectiveness.
Second-line therapies necessitate treatment with combinations of drugs including protease inhibitors[3]. Such high drug concentrations can be achieved by combining protease inhibitors (such as indinavir, saquinavir, amprenavir and lopinavir) with ritonavir (RTV), known to boost the other protease plasma levels through potent inhibition of the cytochrome P450. Low dose RTV (100mg bid) significantly improves pharmacokinetics (AUC and plasma half life) of most protease inhibitors with the exception of nelfinavir. However, these combinations are more expensive, particularly if NRTIs are continued. In addition to increasing cost, continuing NRTIs may not add to the antiviral effect (if resistance is present) and may prolong the toxicity observed during the previous regimen.
Mono boosted PI therapy trials in HIV adults, as maintenance therapy after suppressed viral load, have been shown to be effective and safe [4-6]. This strategy not only decreases number of pill per dose but also saves ARV cost and might improve patient's adherence.
Lopinavir/ritonavir (LPV/r) is widely used protease inhibitor because of its high efficacy and high genetic barrier. As maintenance monotherapy after HIV-1 viral suppression, LPV/r has shown efficacy in 4 adult trials with 81-94% virological suppression[4, 7]. In the OK study[4], the virological failure cases had significantly higher missed doses (p = 0.008). Viral re-suppression after reintroduction of 2NRTIs was achieved in the LPV/r monotherapy arm. A pilot study of switch to LPV/r monotherapy from NNRTI-based therapy was reported with 92% participants on treatment at week 48 having HIV RNA <75 copies/mL[8].
In the OK04 study[9], 196 patients were randomized to eitherLPV/r monotherapy or LPV/r plus 2NRTIs. The percentage of viral suppression to < 50 copies/ml, at week 96 was 77% in the LPV/r monotherapy arm and 78% in the LPV/r plus 2NRTIs arm.
In the MONARK study, LPV/r monotherapy was used in 138 naïve adults and the percentage of viral suppression at week 48 was 71% compared to 75% in the LPV/r plus AZT and 3TC arm[10] (p = 0.69). Two patients in LPV/r monotherapy developed PI mutations but both were able to resuppress HIV-RNA when NRTIs were added. Neither patient displayed phenotypic resistance to LPV/r.
Therefore, we propose this comprehensive study to guide us in identifying the best second line regimen in order to prepare for the large scale antiretroviral resistance problem in Thailand.
- Conditions
- HIV Infections
- Being tested
- LPV/r, LPV/r + TDF/FTC or TDF/3TC
- Keywords
- Second line antiretroviral therapy, HIV genotypic resistance, Kaletra monotherapy, Thailand, 48-week efficacy and safety between 2 NRTIs plus lopinavir/ritonavir (LPV/r) and LPV/r monotherapy in patients failing a standard NNRTI-based treatment regimen, 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 dosing = 400mg/100mg orally q12h for 48 weeks
LPV/r + TDF/FTC or TDF/3TCDrug
TDF/FTC (Truvada) 1 pill orally q 24 hr or TDF 300mg orally q 24 hr/3TC 300mg orally q 24 hr (or 3TC 150mg orally q 12 hr) for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | LPV/r monotherapy Receives: Drug: LPV/r |
| 2 | Active comparator | LPV/r + 2NRTIs (TDF/FTC or TDF/3TC) Receives: Drug: LPV/r + TDF/FTC or TDF/3TC |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the 48-week efficacy and safety between 2 NRTIs plus lopinavir/ritonavir (LPV/r) and LPV/r monotherapy in patients failing a standard NNRTI-based treatment regimen
Measured: 48 weeks
Secondary outcomes (1)
To evaluate the short-term 24-week efficacy and safety of LPV/r monotherapy and interim analyses when 50% of the patients in each arm have reached 24 weeks after randomization 2. To define risk factors for monotherapy failure in HIV-treated individuals
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 startMay 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Security Office, Thailand, Swiss HIV Cohort Study
- Responsible party
- Sponsor
- Investigators
- Kiat Ruxrungtham, MD, Principal investigator, HIV-NAT, The Thai Red Cross AIDS Research Centre (TRCARC), and Faculty of Medicine, Chulalongkorn University, Bangkok, ThailandBernard Hirschel, MD, Principal investigator, Geneva University, Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627055
- Sponsor's protocol ID
- HIV-NAT 079
- Other IDs
- IRB#417/70
- Status last verified
- Jul 2020
- First submitted
- 21 Feb 2008
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Parsons MS, Madhavi V, Ana-Sosa-Batiz F, Center RJ, Wilson KM, Bunupuradah T, Ruxrungtham K, Kent SJ. Brief Report: Seminal Plasma Anti-HIV Antibodies Trigger Antibody-dependent Cellular Cytotoxicity: Implications for HIV Transmission. J Acquir Immune Defic Syndr. 2016 Jan 1;71(1):17-23. doi: 10.1097/QAI.0000000000000804.
PubMed 26761269Bunupuradah T, Chetchotisakd P, Ananworanich J, Munsakul W, Jirajariyavej S, Kantipong P, Prasithsirikul W, Sungkanuparph S, Bowonwatanuwong C, Klinbuayaem V, Kerr SJ, Sophonphan J, Bhakeecheep S, Hirschel B, Ruxrungtham K; HIV STAR Study Group. A randomized comparison of second-line lopinavir/ritonavir monotherapy versus tenofovir/lamivudine/lopinavir/ritonavir in patients failing NNRTI regimens: the HIV STAR study. Antivir Ther. 2012;17(7):1351-61. doi: 10.3851/IMP2443. Epub 2012 Jul 2.
PubMed 23075703Bunupuradah T, Chetchotisakd P, Jirajariyavej S, Valcour V, Bowonwattanuwong C, Munsakul W, Klinbuayaem V, Prasithsirikul W, Sophonphan J, Mahanontharit A, Hirschel B, Bhakeecheep S, Ruxrungtham K, Ananworanich J; HIV STAR Study Group. Neurocognitive impairment in patients randomized to second-line lopinavir/ritonavir-based antiretroviral therapy vs. lopinavir/ritonavir monotherapy. J Neurovirol. 2012 Dec;18(6):479-87. doi: 10.1007/s13365-012-0127-9. Epub 2012 Sep 20.
PubMed 22993101Bunupuradah T, Ananworanich J, Chetchotisakd P, Kantipong P, Jirajariyavej S, Sirivichayakul S, Munsakul W, Prasithsirikul W, Sungkanuparph S, Bowonwattanuwong C, Klinbuayaem V, Petoumenos K, Hirschel B, Bhakeecheep S, Ruxrungtham K. Etravirine and rilpivirine resistance in HIV-1 subtype CRF01_AE-infected adults failing non-nucleoside reverse transcriptase inhibitor-based regimens. Antivir Ther. 2011;16(7):1113-21. doi: 10.3851/IMP1906.
PubMed 22024527
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HIV Second-line Therapy AntiRetroviral Study in Patients Who Failed NNRTI-based Regimens
- ClinicalTrials.gov ID
- NCT00627055
- Acronym / sponsor ID
- HIV-NAT 079
- Conditions
- HIV Infections
- Keywords
- Second line antiretroviral therapy, HIV genotypic resistance, Kaletra monotherapy, Thailand, 48-week efficacy and safety between 2 NRTIs plus lopinavir/ritonavir (LPV/r) and LPV/r monotherapy in patients failing a standard NNRTI-based treatment regimen, treatment experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- National Health Security Office, Thailand, Swiss HIV Cohort Study
- Study start
- May 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (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.
To evaluate the efficacy and safety at 48 weeks between LPV/r monotherapy and 2 NRTIs + LPV/r therapy in patients failing a standard NNRTI-based treatment regimen. Also, to evaluate the short-term 24-week efficacy and safety of Lopinavir/ritonavir (LPV/r) monotherapy and 2 NRTIs+LPV/r therapy in patients failing a standard NNRTI-based treatment regimen as an interim analyses when 50% of the patients in each arm have reached 24 weeks after randomization. Last, to define risk factors for monotherapy failure in HIV-treated individuals
Hypothesis. The rate of virologic suppression is not inferior in the monotherapy arm.
Detailed description
With at least 80,000 HIV-1 infected individuals throughout Thailand currently on generically produced fixed dose combination of d4T/3TC/NVP or GPOvir as a first line national recommendation therapy, we will inevitably face with resistance problem in a large number of patients near future. Therefore a comprehensive investigation into the best second line regimen for these individuals is needed. Given the situation in Thailand where economic burden is a major challenge, the second line regimen will have to offer the greatest possible efficacy, and cost-effectiveness.
Second-line therapies necessitate treatment with combinations of drugs including protease inhibitors[3]. Such high drug concentrations can be achieved by combining protease inhibitors (such as indinavir, saquinavir, amprenavir and lopinavir) with ritonavir (RTV), known to boost the other protease plasma levels through potent inhibition of the cytochrome P450. Low dose RTV (100mg bid) significantly improves pharmacokinetics (AUC and plasma half life) of most protease inhibitors with the exception of nelfinavir. However, these combinations are more expensive, particularly if NRTIs are continued. In addition to increasing cost, continuing NRTIs may not add to the antiviral effect (if resistance is present) and may prolong the toxicity observed during the previous regimen.
Mono boosted PI therapy trials in HIV adults, as maintenance therapy after suppressed viral load, have been shown to be effective and safe [4-6]. This strategy not only decreases number of pill per dose but also saves ARV cost and might improve patient's adherence.
Lopinavir/ritonavir (LPV/r) is widely used protease inhibitor because of its high efficacy and high genetic barrier. As maintenance monotherapy after HIV-1 viral suppression, LPV/r has shown efficacy in 4 adult trials with 81-94% virological suppression[4, 7]. In the OK study[4], the virological failure cases had significantly higher missed doses (p = 0.008). Viral re-suppression after reintroduction of 2NRTIs was achieved in the LPV/r monotherapy arm. A pilot study of switch to LPV/r monotherapy from NNRTI-based therapy was reported with 92% participants on treatment at week 48 having HIV RNA <75 copies/mL[8].
In the OK04 study[9], 196 patients were randomized to eitherLPV/r monotherapy or LPV/r plus 2NRTIs. The percentage of viral suppression to < 50 copies/ml, at week 96 was 77% in the LPV/r monotherapy arm and 78% in the LPV/r plus 2NRTIs arm.
In the MONARK study, LPV/r monotherapy was used in 138 naïve adults and the percentage of viral suppression at week 48 was 71% compared to 75% in the LPV/r plus AZT and 3TC arm[10] (p = 0.69). Two patients in LPV/r monotherapy developed PI mutations but both were able to resuppress HIV-RNA when NRTIs were added. Neither patient displayed phenotypic resistance to LPV/r.
Therefore, we propose this comprehensive study to guide us in identifying the best second line regimen in order to prepare for the large scale antiretroviral resistance problem in Thailand.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: LPV/rLPV/r monotherapy |
| 2 | Active comparator | Drug: LPV/r + TDF/FTC or TDF/3TCLPV/r + 2NRTIs (TDF/FTC or TDF/3TC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years.
- HIV seropositive.
- Have had NNRTI-based HAART in the past for at least 6 months
- Naïve to protease inhibitors (PIs)
- Plasma HIVRNA ≥ 1000 copies/ml
Key exclusion criteria (7 listed)
- Active AIDS-defining disease or active opportunistic infection
- Previously treated with PIs
- Pregnancy (negative pregnancy test for women of childbearing potential at screening).
- Documented chronic hepatitis B (HbsAg positive)
- ALT ≥ 200 U/L
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 dosing = 400mg/100mg orally q12h for 48 weeks | Drug | 1 |
| LPV/r + TDF/FTC or TDF/3TCTDF/FTC (Truvada) 1 pill orally q 24 hr or TDF 300mg orally q 24 hr/3TC 300mg orally q 24 hr (or 3TC 150mg orally q 12 hr) for 48 weeks | Drug | 2 |
Primary outcome
To evaluate the 48-week efficacy and safety between 2 NRTIs plus lopinavir/ritonavir (LPV/r) and LPV/r monotherapy in patients failing a standard NNRTI-based treatment regimen
Time frame: 48 weeks
1 secondary outcome
To evaluate the short-term 24-week efficacy and safety of LPV/r monotherapy and interim analyses when 50% of the patients in each arm have reached 24 weeks after randomization 2. To define risk factors for monotherapy failure in HIV-treated individuals
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 17 Jul 2020.
- Derived from this study: PubMed 26761269Parsons MS, Madhavi V, Ana-Sosa-Batiz F, Center RJ, Wilson KM, Bunupuradah T, Ruxrungtham K, Kent SJ. Brief Report: Seminal Plasma Anti-HIV Antibodies Trigger Antibody-dependent Cellular Cytotoxicity: Implications for HIV Transmission. J Acquir Immune Defic Syndr. 2016 Jan 1;71(1):17-23. doi: 10.1097/QAI.0000000000000804.
- Derived from this study: PubMed 23075703Bunupuradah T, Chetchotisakd P, Ananworanich J, Munsakul W, Jirajariyavej S, Kantipong P, Prasithsirikul W, Sungkanuparph S, Bowonwatanuwong C, Klinbuayaem V, Kerr SJ, Sophonphan J, Bhakeecheep S, Hirschel B, Ruxrungtham K; HIV STAR Study Group. A randomized comparison of second-line lopinavir/ritonavir monotherapy versus tenofovir/lamivudine/lopinavir/ritonavir in patients failing NNRTI regimens: the HIV STAR study. Antivir Ther. 2012;17(7):1351-61. doi: 10.3851/IMP2443. Epub 2012 Jul 2.
- Derived from this study: PubMed 22993101Bunupuradah T, Chetchotisakd P, Jirajariyavej S, Valcour V, Bowonwattanuwong C, Munsakul W, Klinbuayaem V, Prasithsirikul W, Sophonphan J, Mahanontharit A, Hirschel B, Bhakeecheep S, Ruxrungtham K, Ananworanich J; HIV STAR Study Group. Neurocognitive impairment in patients randomized to second-line lopinavir/ritonavir-based antiretroviral therapy vs. lopinavir/ritonavir monotherapy. J Neurovirol. 2012 Dec;18(6):479-87. doi: 10.1007/s13365-012-0127-9. Epub 2012 Sep 20.
- Derived from this study: PubMed 22024527Bunupuradah T, Ananworanich J, Chetchotisakd P, Kantipong P, Jirajariyavej S, Sirivichayakul S, Munsakul W, Prasithsirikul W, Sungkanuparph S, Bowonwattanuwong C, Klinbuayaem V, Petoumenos K, Hirschel B, Bhakeecheep S, Ruxrungtham K. Etravirine and rilpivirine resistance in HIV-1 subtype CRF01_AE-infected adults failing non-nucleoside reverse transcriptase inhibitor-based regimens. Antivir Ther. 2011;16(7):1113-21. doi: 10.3851/IMP1906.
- 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.
Kiat Ruxrungtham, MD principal investigator
HIV-NAT, The Thai Red Cross AIDS Research Centre (TRCARC), and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
Bernard Hirschel, MD principal investigator
Geneva University, Geneva, Switzerland
10 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 and LPV/r + TDF/FTC or TDF/3TC in people with HIV Infections, run by The HIV Netherlands Australia Thailand Research Collaboration at 10 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 6 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 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 the 48-week efficacy and safety between 2 NRTIs plus lopinavir/ritonavir (LPV/r) and LPV/r monotherapy in patients failing a standard NNRTI-based treatment regimen (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 NCT00627055, which also lists 4 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 17 Jul 2020.