HIV InfectionsPhase 4NCT00160849
Lopinavir/r Monotherapy as Maintenance Therapy After Long Term Viral Suppression
A Phase 4 study testing Lopinavir/r in people with HIV Infections, run by Universidade Federal do Rio de Janeiro at 2 sites in Brazil.
Trial summary
1. Objectives Primary To investigate the possibility of maintaining virological suppression of HIV in infected patients, switching them to LPV/r as the only antiretroviral agent To assess the immunological response in patients who switched to LPV/r as single agent, based on the observation of changes in the serum… 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?
- Lopinavir/r
- How many people
- 60 participants
- Where
- 2 sitesBrazil
- Study dates
- Aug 2004to Mar 2007
- 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
- The patients must fulfill all of the following criteria: The patient has confirmed his/her willingness to participate in the study, after being informed about all the aspects of the study that might be relevant for his/her decision to participate, and has signed and dated the informed consent form, as approved by the Institutional Review Board/ Ethics Committee (IRB/EC). And he/she can withdraw the study participation at any moment, if he/she wants to do so.
- The patient has laboratorial confirmation of an HIV infection through a positive ELISA test for anti-HIV antibodies and an additional test (Western-blot, indirect immunofluorescence or PCR).
- The patient must be in treatment with at least three antiretroviral drugs, for at least 6 months without changes.
- The patient should have no history of documented virological failure to previously used antiretroviral therapies.
- Undetectable viral load (test result < 400 copies/ml) for more than 6 months measured on a sample collected during treatment with the current regimen and at screening (test result < 80 copies).
- CD4 count > 200 cels/ml at screening
- Patient agrees not to use concomitant medication that might have unacceptable drug interactions with the study drug.
- If the patient is a female, she must have a negative pregnancy test and must agree to use at least 14 days before the study drug administration and for the whole study duration and up to 6 months after, a barrier contraceptive method with a proven reliability track record, as judged by the investigator
Who cannot join
- Pregnant or lactating female patient. If the patient becomes pregnant during the study, she will be discontinued from the study.
- Patients with allergic reaction or hypersensitivity to Lopinavir or Ritonavir .
- A patient with previous history of opportunistic disease ( appendix 1) or CD4 count below 100 cels/mm3.
- A patient who presents any HIV viral load test result above 400 copies/mL over the past 6 months.
- Patient who is receiving or has received systemic chemotherapy during the past 6 months.
- Laboratory test results Hemoglobin < 8 g/dl Absolute neutrophil count < 750 cels/mL Platelet count < 20,000/mL Bilirubin > 1.5 x UNL or > 6 x UNL if patient is using Indinavir or Atazanavir ALT and AST > 2 x UNL Creatinine > 2 x UNL
- Patient is taking any drug known to be contraindicated concomitantly with lopinavir/r. Please refer to the product's package insert.
- According to the investigator's opinion, the patient has little probability of complying with the study protocol or is unsuitable for any other reason.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital Geral de Nova Iguaçu
Nova Iguaçu, Rio de Janeiro, 01620.020
Projeto Praça Onze
Rio de Janeiro, Rio de Janeiro, 20210.030
About this study
Official title: Study on the Feasibility of Antiretroviral Therapy With a Single Agent - Lopinavir/r - in Patients Treated With HAART and With Viral Load Below 80 Copies/Ml
- Objectives Primary
- To investigate the possibility of maintaining virological suppression of HIV in infected patients, switching them to LPV/r as the only antiretroviral agent
- To assess the immunological response in patients who switched to LPV/r as single agent, based on the observation of changes in the serum levels of CD4+ cells. Secondary
- To investigate the rate of clinical and laboratorial adverse events in the two treatment groups.
- To investigate the rate of emergence of antiretroviral resistance mutations in the two treatment groups, in case of virological failure of the current regimen.
- To describe the adherence to the prescribed regimen in the two treatment groups
- To describe changes in body fat distribution (abdominal, arms and thigh circumference) and in the lipid profile, in patients from the two treatment groups
- To describe the rate of clinical failure of the antiretroviral therapy in the two treatment groups.
Read more
- Patient population: The 60 patients were selected by the investigators according to the study's inclusion and exclusion criteria, and were divided into 2 groups with 30 patients each.
- Study design: The study is multicentric, open-label, randomized. Virological, immunological and clinical failures will be analyzed in both groups. In addition, data on clinical or laboratorial toxicity and compliance are being recorded.
- Regime:
- Group 1 maintenance of the currently used antiretroviral therapy
- Group 2 switch to LPV/r antiretroviral monotherapy in the dose of 400/100 mg 12/12 hs with food. Patients in group 2 who were being treated previously with non-nucleoside reverse transcriptase inhibitors (Efavirenz or Nevirapine) were instructed to take 4 capsules of Lopinavir/r each 12 hs, during the first 14 days of therapy (up to Week 2 visit).
- Duration:
96 weeks of treatment
- Conditions
- HIV Infections
- Being tested
- Lopinavir/r
- Keywords
- 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.
Lopinavir/rDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
• Rate of suppression of viral load to less than 80 copies/ml on weeks 4, 12, 24, 36, 48, 60, 72, 84, 96.
• Average change of CD4 count on weeks 4, 12, 24, 36, 48, 60, 72, 84, 96
• Two-year incidence rate of immunodeficiency related clinical conditions.
Secondary outcomes (1)
• Toxicity rate (clinical and laboratorial adverse events).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 2004
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 60 participants
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Investigators
- Estevão P Nunes, M.Sc, Principal investigator, Projeto Praça Onze
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00160849
- Sponsor's protocol ID
- KalMo
- Status last verified
- Jul 2005
- First submitted
- 8 Sep 2005
- Last updated
- 21 Oct 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Feasibility of Antiretroviral Therapy With a Single Agent - Lopinavir/r - in Patients Treated With HAART and With Viral Load Below 80 Copies/Ml
- ClinicalTrials.gov ID
- NCT00160849
- Acronym / sponsor ID
- KalMo
- Conditions
- HIV Infections
- Keywords
- Treatment Experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- Aug 2004
- Study completion
- Mar 2007
- First posted
- 12 Sep 2005 (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.
- Objectives Primary
- To investigate the possibility of maintaining virological suppression of HIV in infected patients, switching them to LPV/r as the only antiretroviral agent
- To assess the immunological response in patients who switched to LPV/r as single agent, based on the observation of changes in the serum levels of CD4+ cells. Secondary
- To investigate the rate of clinical and laboratorial adverse events in the two treatment groups.
- To investigate the rate of emergence of antiretroviral resistance mutations in the two treatment groups, in case of virological failure of the current regimen.
- To describe the adherence to the prescribed regimen in the two treatment groups
- To describe changes in body fat distribution (abdominal, arms and thigh circumference) and in the lipid profile, in patients from the two treatment groups
- To describe the rate of clinical failure of the antiretroviral therapy in the two treatment groups.
- Patient population: The 60 patients were selected by the investigators according to the study's inclusion and exclusion criteria, and were divided into 2 groups with 30 patients each.
- Study design: The study is multicentric, open-label, randomized. Virological, immunological and clinical failures will be analyzed in both groups. In addition, data on clinical or laboratorial toxicity and compliance are being recorded.
- Regime:
- Group 1 maintenance of the currently used antiretroviral therapy
- Group 2 switch to LPV/r antiretroviral monotherapy in the dose of 400/100 mg 12/12 hs with food. Patients in group 2 who were being treated previously with non-nucleoside reverse transcriptase inhibitors (Efavirenz or Nevirapine) were instructed to take 4 capsules of Lopinavir/r each 12 hs, during the first 14 days of therapy (up to Week 2 visit).
- Duration:
96 weeks of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patients must fulfill all of the following criteria: The patient has confirmed his/her willingness to participate in the study, after being informed about all the aspects of the study that might be relevant for his/her decision to participate, and has signed and dated the informed consent form, as approved by the Institutional Review Board/ Ethics Committee (IRB/EC). And he/she can withdraw the study participation at any moment, if he/she wants to do so.
- The patient has laboratorial confirmation of an HIV infection through a positive ELISA test for anti-HIV antibodies and an additional test (Western-blot, indirect immunofluorescence or PCR).
- The patient must be in treatment with at least three antiretroviral drugs, for at least 6 months without changes.
- The patient should have no history of documented virological failure to previously used antiretroviral therapies.
- Undetectable viral load (test result < 400 copies/ml) for more than 6 months measured on a sample collected during treatment with the current regimen and at screening (test result < 80 copies).
Key exclusion criteria (8 listed)
- Pregnant or lactating female patient. If the patient becomes pregnant during the study, she will be discontinued from the study.
- Patients with allergic reaction or hypersensitivity to Lopinavir or Ritonavir .
- A patient with previous history of opportunistic disease ( appendix 1) or CD4 count below 100 cels/mm3.
- A patient who presents any HIV viral load test result above 400 copies/mL over the past 6 months.
- Patient who is receiving or has received systemic chemotherapy during the past 6 months.
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 |
|---|---|---|
| Lopinavir/r | Drug | – |
Primary outcome
• Rate of suppression of viral load to less than 80 copies/ml on weeks 4, 12, 24, 36, 48, 60, 72, 84, 96.
• Average change of CD4 count on weeks 4, 12, 24, 36, 48, 60, 72, 84, 96
• Two-year incidence rate of immunodeficiency related clinical conditions.
1 secondary outcome
• Toxicity rate (clinical and laboratorial adverse events).
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 21 Oct 2005.
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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.
Estevão P Nunes, M.Sc principal investigator
Projeto Praça Onze
2 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 Lopinavir/r in people with HIV Infections, run by Universidade Federal do Rio de Janeiro at 2 sites in Brazil.
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 8 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 21 Oct 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
• Rate of suppression of viral load to less than 80 copies/ml on weeks 4, 12, 24, 36, 48, 60, 72, 84, 96.. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2005.