HIV-1 InfectionPhase 4NCT01772940
Nevirapine vs Ritonavir-boosted Lopinavir in ART Naive HIV-infected Adults in a Resource Limited Setting
A Phase 4 study testing nevirapine, ritonavir-boosted Lopinavir and Tenofovir/emtricitabine in people with HIV-1 Infection, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Republic of the Congo.
Trial summary
In resource-limited setting, concerns remain regarding the emergence of virologic failure and high-level drug resistance mutations (DRM) during WHO recommended first-line antiretroviral therapy (ART) with non-nucleoside reverse transcriptase inhibitors (NNRTI) based regimens for Human immunodeficiency virus 1 (HIV1)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- nevirapine, ritonavir-boosted Lopinavir and Tenofovir/emtricitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 425 participants
- Where
- 1 siteRepublic of the Congo
- Study dates
- Dec 2008to Dec 2011
- 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
- Antiretroviral-therapy naïve HIV-1 infected Adults
- WHO clinical stage 3 and CD4 <350/mm3 or
- WHO clinical stage 4 or
- CD4 cell count < 200/mm3
- Negative pregnancy test
Who cannot join
- Hemoglobin < 8.5 g/dL (female) or 9.0 g/dL (male)
- Estimated Glomerular Filtration Rate < 50 ml/ minute (Cockcroft-Gault equation)
- Hepatic transaminases (AST and ALT)> 3 x upper limit of normal
- Active tuberculosis
- Pregnancy
- Females who are breastfeeding
Trial locations and contacts
1 site in 1 country.
Republic of the Congo1 site
Cliniques Universitaires de Lubumbashi
Lubumbashi, Katanga
About this study
Official title: Nevirapine vs Ritonavir-boosted Lopinavir in ART HIV-infected Adults in a Resource-limited Setting; a Randomized, Multicenter, Parallel Group Study
In resource-limited setting, concerns remain regarding the emergence of virologic failure and high-level drug resistance mutations (DRM) during WHO recommended first-line antiretroviral therapy (ART) with non-nucleoside reverse transcriptase inhibitors (NNRTI) based regimens for Human immunodeficiency virus 1 (HIV1) infected patients. The study hypothesis is that a boosted-protease inhibitor regimen has a better outcome than a NNRTI-based regimen with a low genetic barrier to resistance.
The study is a randomized, multicenter, factorial trial (conducted in Congo), in treatment- naïve adults receiving for 96 weeks ritonavir- boosted lopinavir(LPV/r) or nevirapine (NVP) each in combination with tenofovir (TDF) /emtricitabine (FTC) or zidovudine (ZDV)/lamivudine (3TC). The primary end point is the incidence of therapeutic (clinical and/or virologic)failure by study week 24.
- Conditions
- HIV-1 Infection
- Being tested
- nevirapine, ritonavir-boosted Lopinavir, Tenofovir/emtricitabine, Zidovudine/lamivudine
- Keywords
- First-line therapy, Protease inhibitor, Non-Nucleoside Reverse transcriptase Inhibitor, Resource-limited setting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nevirapineDrug
Also called Viramune
Nevirapine 200 mg twice daily or 400 mg once daily per os during 96 weeks
ritonavir-boosted LopinavirDrug
Also called Aluvia
ritonavir-boosted lopinavir 800/200 mg once daily or 400/100 mg twice daily per os during 96 weeks
Tenofovir/emtricitabineDrug
Also called Truvada
tenofovir 300 mg/emtricitabine 200 mg fixed-dose combination once daily, per os for 96 weeks
Zidovudine/lamivudineDrug
Also called Zidolam,combivir
zidovudine 300 mg/lamivudine 150 mg twice daily fixed-dose generic combination, per os for 96 weeks
| Study group | Role | What they receive |
|---|---|---|
| nevirapine and tenofovir/emtricitabine | Active comparator | nevirapine 200 mg twice daily combined with tenofovir 300 mg/emtricitabine 200 mg (fixed-dose combination) once daily, per os for 96 weeks Receives: Drug: nevirapine; Drug: Tenofovir/emtricitabine |
| lopinavir/r and tenofovir/emtricitabine | Experimental | ritonavir-boosted lopinavir 800/200 mg once daily or 400/100 mg twice daily combined with tenofovir 300 mg/emtricitabine 200 mg (fixed-dose combination) once daily, per os for 96 weeks Receives: Drug: ritonavir-boosted Lopinavir; Drug: Tenofovir/emtricitabine |
| Nevirapine and zidovudine/lamivudine | Active comparator | nevirapine 200 mg/zidovudine 300 mg/lamivudine 150 mg (fixed-dose combination) twice daily, per os for 96 weeks Receives: Drug: nevirapine; Drug: Zidovudine/lamivudine |
| Lopinavir/r and zidovudine/lamivudine | Experimental | ritonavir-boosted lopinavir 800/200 mg once daily or 400/100 mg once daily combined with zidovudine 300 mg/lamivudine 150 mg once daily, per os for 96 weeks Receives: Drug: ritonavir-boosted Lopinavir; Drug: Zidovudine/lamivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of therapeutic failure
The primary end point is the proportion of patients with therapeutic failure defined as:
- the occurence or relapse by week 24 of a World Health Organization (WHO) stage 4 or 3 event, or
- death by week 24, or
- discontinuation of study drugs due to toxicity at any time, or
- virological failure defined as HIV-1 RNA > 1000 copies/ml by week 24
Measured: At week 48 with follow-up until week 96
Secondary outcomes (5)
HIV-1 RNA viral load less than 50 copies/ml
The percentage of patients with HIV-1 RNA < 50 copies/ml
Measured: Through week 96
Immunologic response
Cluster of differentiation 4 (CD4) cell count change from baseline
Measured: Through week 96
HIV-1 resistance mutations
Measured: At baseline and at the time of virologic failure
Safety and tolerability
Incidence of adverse events and laboratory abnormalities
Measured: Through week 96
Changes in laboratory parameters
Measured: Through week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startDec 2008
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1 InfectionStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liege, Ministry of Public Health, Democratic Republic of the Congo, Pierre and Marie Curie University, University Paris 7 - Denis Diderot, Gilead Sciences, Abbott
- Responsible party
- Principal investigator, Clumeck Nathan, Centre Hospitalier Universitaire Saint Pierre
- Investigators
- Nathan Clumeck, MD, PhD, Principal investigator, Centre Hospitalier Universitaire Saint Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772940
- Sponsor's protocol ID
- Lubumbashi trial
- Status last verified
- Aug 2013
- First submitted
- 14 Jan 2013
- Last updated
- 26 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Clumeck N, Mwamba C, Kabeya K, Matanda S, Vaira D, Necsoi C, Kadiebwe D, Delforge M, Kasamba E, Milolo C, Ilunga J, Kapend L. First-line antiretroviral therapy with nevirapine versus lopinavir-ritonavir based regimens in a resource-limited setting. AIDS. 2014 May 15;28(8):1143-53. doi: 10.1097/QAD.0000000000000214.
PubMed 25028911
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nevirapine vs Ritonavir-boosted Lopinavir in ART HIV-infected Adults in a Resource-limited Setting; a Randomized, Multicenter, Parallel Group Study
- ClinicalTrials.gov ID
- NCT01772940
- Acronym / sponsor ID
- Lubumbashi trial
- Conditions
- HIV-1 Infection
- Keywords
- First-line therapy, Protease inhibitor, Non-Nucleoside Reverse transcriptase Inhibitor, Resource-limited setting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Collaborators
- University of Liege, Ministry of Public Health, Democratic Republic of the Congo, Pierre and Marie Curie University, University Paris 7 - Denis Diderot, Gilead Sciences, Abbott
- Study start
- Dec 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Jan 2013 (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.
In resource-limited setting, concerns remain regarding the emergence of virologic failure and high-level drug resistance mutations (DRM) during WHO recommended first-line antiretroviral therapy (ART) with non-nucleoside reverse transcriptase inhibitors (NNRTI) based regimens for Human immunodeficiency virus 1 (HIV1) infected patients. The study hypothesis is that a boosted-protease inhibitor regimen has a better outcome than a NNRTI-based regimen with a low genetic barrier to resistance.
The study is a randomized, multicenter, factorial trial (conducted in Congo), in treatment- naïve adults receiving for 96 weeks ritonavir- boosted lopinavir(LPV/r) or nevirapine (NVP) each in combination with tenofovir (TDF) /emtricitabine (FTC) or zidovudine (ZDV)/lamivudine (3TC). The primary end point is the incidence of therapeutic (clinical and/or virologic)failure by study week 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| nevirapine and tenofovir/emtricitabine | Active comparator | Drug: nevirapine, Drug: Tenofovir/emtricitabinenevirapine 200 mg twice daily combined with tenofovir 300 mg/emtricitabine 200 mg (fixed-dose combination) once daily, per os for 96 weeks |
| lopinavir/r and tenofovir/emtricitabine | Experimental | Drug: ritonavir-boosted Lopinavir, Drug: Tenofovir/emtricitabineritonavir-boosted lopinavir 800/200 mg once daily or 400/100 mg twice daily combined with tenofovir 300 mg/emtricitabine 200 mg (fixed-dose combination) once daily, per os for 96 weeks |
| Nevirapine and zidovudine/lamivudine | Active comparator | Drug: nevirapine, Drug: Zidovudine/lamivudinenevirapine 200 mg/zidovudine 300 mg/lamivudine 150 mg (fixed-dose combination) twice daily, per os for 96 weeks |
| Lopinavir/r and zidovudine/lamivudine | Experimental | Drug: ritonavir-boosted Lopinavir, Drug: Zidovudine/lamivudineritonavir-boosted lopinavir 800/200 mg once daily or 400/100 mg once daily combined with zidovudine 300 mg/lamivudine 150 mg once daily, per os for 96 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Antiretroviral-therapy naïve HIV-1 infected Adults
- WHO clinical stage 3 and CD4 <350/mm3 or
- WHO clinical stage 4 or
- CD4 cell count < 200/mm3
- Negative pregnancy test
Key exclusion criteria (6 listed)
- Hemoglobin < 8.5 g/dL (female) or 9.0 g/dL (male)
- Estimated Glomerular Filtration Rate < 50 ml/ minute (Cockcroft-Gault equation)
- Hepatic transaminases (AST and ALT)> 3 x upper limit of normal
- Active tuberculosis
- 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 |
|---|---|---|
| nevirapineAlso: ViramuneNevirapine 200 mg twice daily or 400 mg once daily per os during 96 weeks | Drug | Nevirapine and zidovudine/lamivudine, nevirapine and tenofovir/emtricitabine |
| ritonavir-boosted LopinavirAlso: Aluviaritonavir-boosted lopinavir 800/200 mg once daily or 400/100 mg twice daily per os during 96 weeks | Drug | Lopinavir/r and zidovudine/lamivudine, lopinavir/r and tenofovir/emtricitabine |
| Tenofovir/emtricitabineAlso: Truvadatenofovir 300 mg/emtricitabine 200 mg fixed-dose combination once daily, per os for 96 weeks | Drug | lopinavir/r and tenofovir/emtricitabine, nevirapine and tenofovir/emtricitabine |
| Zidovudine/lamivudineAlso: Zidolam,combivirzidovudine 300 mg/lamivudine 150 mg twice daily fixed-dose generic combination, per os for 96 weeks | Drug | Lopinavir/r and zidovudine/lamivudine, Nevirapine and zidovudine/lamivudine |
Primary outcome
Incidence of therapeutic failure
Time frame: At week 48 with follow-up until week 96
The primary end point is the proportion of patients with therapeutic failure defined as: * the occurence or relapse by week 24 of a World Health Organization (WHO) stage 4 or 3 event, or * death by week 24, or * discontinuation of study drugs due to toxicity at any time, or * virological failure defined as HIV-1 RNA > 1000 copies/ml by week 24
5 secondary outcomes
HIV-1 RNA viral load less than 50 copies/ml
Time frame: Through week 96
Immunologic response
Time frame: Through week 96
HIV-1 resistance mutations
Time frame: At baseline and at the time of virologic failure
Safety and tolerability
Time frame: Through week 96
Changes in laboratory parameters
Time frame: Through week 96
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 Aug 2013.
- Derived from this study: PubMed 25028911Clumeck N, Mwamba C, Kabeya K, Matanda S, Vaira D, Necsoi C, Kadiebwe D, Delforge M, Kasamba E, Milolo C, Ilunga J, Kapend L. First-line antiretroviral therapy with nevirapine versus lopinavir-ritonavir based regimens in a resource-limited setting. AIDS. 2014 May 15;28(8):1143-53. doi: 10.1097/QAD.0000000000000214.
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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.
Nathan Clumeck, MD, PhD principal investigator
Centre Hospitalier Universitaire Saint Pierre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nevirapine, ritonavir-boosted Lopinavir and Tenofovir/emtricitabine in people with HIV-1 Infection, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Republic of the Congo.
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 6 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 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Republic of the Congo. 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?
Incidence of therapeutic failure (time frame: At week 48 with follow-up until week 96). 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 NCT01772940, which also lists 1 linked publication.
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 Aug 2013.