HIV InfectionPhase 4KALIPONCT00865475
Prevention of Lipoatrophy in Patients Treated With Lopinavir/Ritonavir in Monotherapy Versus ZDV + 3TC + ABC
A Phase 4 study testing AZT+3TC+ABV (Trizivir) and Switching to LPV/r monotherapy (Kaletra) in people with HIV Infection and HIV Infections, run by Fundacion SEIMC-GESIDA at 7 sites in Spain.
Trial summary
The aim of this study is to measure the prevention of lipoatrophy in patients treated with Lopinavir/R in monotherapy versus ZDV + 3TC + ABC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection, HIV Infections
- What is being tested?
- AZT+3TC+ABV (Trizivir) and Switching to LPV/r monotherapy (Kaletra)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 7 sitesSpain
- Study dates
- Dec 2008to Mar 2013
- 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
- Patients infected with HIV 1 documented by positive HIV 1 antibody test and/or positive PCR test confirmed for HIV 1 RNA.
- Patients on treatment with Trizivir with an undetectable viral burden defined as < 50 copies/ml in the past 6 months.
- Men or women aged ≥ 18 years.
- CD4 cell count ≥ 200 cells/μl.
- For women of child bearing age, a negative urine pregnancy test at the screening visit.
- Patients giving their written informed consent before completing any study specific screening procedure.
Who cannot join
- Patients with previously failed therapy with protease inhibitors (PI) or those receiving sub optimum therapy with nucleoside analogue reverse transcriptase inhibitors (NRTI) for the study disease.
- Presence of lipoatrophy defined by the investigator (any grade) or by the patient (in this case, at least two sites of mild degree or one of at least moderate degree).
- Known history of drug addiction or chronic use of alcohol that, in the investigator's opinion, contraindicates participation in the study.
- Pregnant or nursing women or women of child bearing age not using an adequate contraceptive method according to the investigator's criterion.
- Current active opportunistic infection or documented infection in the 4 weeks prior to screening.
- Renal disease with creatinine clearance < 50 ml/min.
Show all 11Show fewer
- Concomitant use of nephrotoxic or immunosuppressive agents.
- Patient currently treated with systemic corticosteroids, interleukine 2, or chemotherapy.
- Patients treated with other investigational agents.
- Patients with acute hepatitis.
- Any disease that, at the criterion in the investigator, contraindicates the patient's participation in the study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Hospital de Basurto
Bilbao, Vizcaya, 48013
Hospital de Donostia
Donostia / San Sebastian, San Sebastian, 20014
Hospital Severo Ochoa
Leganés, Madrid, 28911
Hospital Doce de Octubre
Madrid, Madrid, 28041
Hospital La Paz
Madrid, Madrid, 28046
H. Son Dureta
Mallorca
Hospital Ntra.Sra. de Zumarraga
Zumarraga, Guipuzcua, 28700
About this study
Official title: A Randomized Comparative Clinical Trial of ZDV + 3TC + ABC (Trizivir) vs Monotherapy With Lopinavir/R (Kaletra) in Patients With Viral Suppression on Previous Treatment With ZDV + 3TC + ABC (Trizivir) for Preventing Lipoatrophy
The aim of this study is to measure the prevention of lipoatrophy in patients treated with Lopinavir/R in monotherapy versus ZDV + 3TC + ABC
Read the detailed description
In recent years mayor progress has been made in therapeutic approaches with the introduction of HAART, which has meant a huge fall in morbidity-mortality in Western countries.
However, despite having a variety of potent HAART combinations, some patients do not obtain adequate suppression. The causes of virological failure are complex, and one of the most significant factors is the incomplete compliance with the prescribed dosage of highly-active antiretroviral therapy (HAART). The development of fixed dose combination products is most commonly used to help simplify the dosages and improve treatment compliance.
One of the main problems associated with the treatment of HIV infection is the change in body structure, generally grouped under the term of lipodystrophy. These usually include fat accumulation in the stomach, or abdominal girth, and, even worse, atrophy in the face, arms, and legs. It is usually associated with metabolic disorders, with increased levels of triglycerides, cholesterol and/or insulin resistance.
The incidence of lipodystrophy increases progressively over time in patients starting treatment with antiretroviral agents. It is estimated that, after 2 years of treatment, 20%-30% of patients experience moderate or severe lipodystrophy.
Trizivir® is a combination of three antiretroviral agents: Abacavir, Lamivudine and Zidovudine in a tablet. All of them belong to the group of nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs.
The main advantage of Trizivir is the possibility of simplifying antiretroviral treatment. Multiple studies have been performed showing that simplification of HAART with Trizivir enhances compliance and improves quality of life in patients maintaining the efficacy of previous antiretroviral treatments.
Kaletra® (lopinavir+ritonavir) is a combination of two protease inhibitors: lopinavir plus a low dose of ritonavir, enhancing the action of the former.
Previous studies have shown that most patients treated with Kaletra monotherapy have an undetectable viral load after 48 weeks. Monotherapy failures were not associated with the development of primary resistance mutations.
To date the development of lipoatrophy appears to occur more frequently in patients with a NRTI- containing regimen. The combination of abacavir, zidovudine and lamivudine has been investigated in patients naive to antiretroviral treatments and in patients already treated with NRTIs.
In this setting, we designed this clinical trial to establish the potential benefit of Kaletra in monotherapy for the prevention of lipoatrophy. For this purpose, we will compare keeping on treatment with TZV in patients with viral suppression vs switching to Kaletra in monotherapy in order to prevent fat changes.
Since the purpose of the study is to establish the ability of Kaletra to prevent the development of and exclude patients with acute intolerance to Kaletra, the patients assigned to the experimental group will be treated for 4 weeks with Trizivir and Kaletra before switching to Kaletra monotherapy.
- Conditions
- HIV Infection, HIV Infections
- Being tested
- AZT+3TC+ABV (Trizivir), Switching to LPV/r monotherapy (Kaletra)
- Keywords
- HIV infection, 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.
AZT+3TC+ABV (Trizivir)Drug
Also called LPV/r (Kaletra)
Patients on treatment with TZV and viral suppression will be randomized to keep on TZV vs switching to LPV/r monotherapy
Switching to LPV/r monotherapy (Kaletra)Drug
Also called Kaletra
Patients on AZT+3TC+ABV with viral suppression will be randomized to keep on vs switching to LPV/r
| Study group | Role | What they receive |
|---|---|---|
| TZV (Trizivir) | No intervention | Keeping on TZV in patients with viral suppression |
| 2 | Experimental | Switching to LPV/r monotherapy Receives: Drug: AZT+3TC+ABV (Trizivir); Drug: Switching to LPV/r monotherapy (Kaletra) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb Fat changes measured by DEXA
Measured: 48 weeks
Secondary outcomes (3)
20 % loss peripheral fat measured by DEXA
Measured: 96 weeks
Perception of change on body fat by physician and patient.
Measured: 96 weeks
Lipohypertrophy
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startDec 2008
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion SEIMC-GESIDA
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Jose Antonio Iribarren, Study chair, Hospital de Donostia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00865475
- Sponsor's protocol ID
- GESIDA 6108
- Other IDs
- 2008-003438-12, 6108, 2008
- Acronym
- KALIPO
- Status last verified
- Sep 2013
- First submitted
- 18 Mar 2009
- Last updated
- 12 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparative Clinical Trial of ZDV + 3TC + ABC (Trizivir) vs Monotherapy With Lopinavir/R (Kaletra) in Patients With Viral Suppression on Previous Treatment With ZDV + 3TC + ABC (Trizivir) for Preventing Lipoatrophy
- ClinicalTrials.gov ID
- NCT00865475
- Acronym / sponsor ID
- KALIPO / GESIDA 6108
- Conditions
- HIV Infection, HIV Infections
- Keywords
- HIV infection, Treatment Experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Fundacion SEIMC-GESIDAUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Dec 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 19 Mar 2009 (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 aim of this study is to measure the prevention of lipoatrophy in patients treated with Lopinavir/R in monotherapy versus ZDV + 3TC + ABC
Detailed description
In recent years mayor progress has been made in therapeutic approaches with the introduction of HAART, which has meant a huge fall in morbidity-mortality in Western countries.
However, despite having a variety of potent HAART combinations, some patients do not obtain adequate suppression. The causes of virological failure are complex, and one of the most significant factors is the incomplete compliance with the prescribed dosage of highly-active antiretroviral therapy (HAART). The development of fixed dose combination products is most commonly used to help simplify the dosages and improve treatment compliance.
One of the main problems associated with the treatment of HIV infection is the change in body structure, generally grouped under the term of lipodystrophy. These usually include fat accumulation in the stomach, or abdominal girth, and, even worse, atrophy in the face, arms, and legs. It is usually associated with metabolic disorders, with increased levels of triglycerides, cholesterol and/or insulin resistance.
The incidence of lipodystrophy increases progressively over time in patients starting treatment with antiretroviral agents. It is estimated that, after 2 years of treatment, 20%-30% of patients experience moderate or severe lipodystrophy.
Trizivir® is a combination of three antiretroviral agents: Abacavir, Lamivudine and Zidovudine in a tablet. All of them belong to the group of nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs.
The main advantage of Trizivir is the possibility of simplifying antiretroviral treatment. Multiple studies have been performed showing that simplification of HAART with Trizivir enhances compliance and improves quality of life in patients maintaining the efficacy of previous antiretroviral treatments.
Kaletra® (lopinavir+ritonavir) is a combination of two protease inhibitors: lopinavir plus a low dose of ritonavir, enhancing the action of the former.
Previous studies have shown that most patients treated with Kaletra monotherapy have an undetectable viral load after 48 weeks. Monotherapy failures were not associated with the development of primary resistance mutations.
To date the development of lipoatrophy appears to occur more frequently in patients with a NRTI- containing regimen. The combination of abacavir, zidovudine and lamivudine has been investigated in patients naive to antiretroviral treatments and in patients already treated with NRTIs.
In this setting, we designed this clinical trial to establish the potential benefit of Kaletra in monotherapy for the prevention of lipoatrophy. For this purpose, we will compare keeping on treatment with TZV in patients with viral suppression vs switching to Kaletra in monotherapy in order to prevent fat changes.
Since the purpose of the study is to establish the ability of Kaletra to prevent the development of and exclude patients with acute intolerance to Kaletra, the patients assigned to the experimental group will be treated for 4 weeks with Trizivir and Kaletra before switching to Kaletra monotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TZV (Trizivir) | No intervention | –Keeping on TZV in patients with viral suppression |
| 2 | Experimental | Drug: AZT+3TC+ABV (Trizivir), Drug: Switching to LPV/r monotherapy (Kaletra)Switching to LPV/r monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients infected with HIV 1 documented by positive HIV 1 antibody test and/or positive PCR test confirmed for HIV 1 RNA.
- Patients on treatment with Trizivir with an undetectable viral burden defined as < 50 copies/ml in the past 6 months.
- Men or women aged ≥ 18 years.
- CD4 cell count ≥ 200 cells/μl.
- For women of child bearing age, a negative urine pregnancy test at the screening visit.
Key exclusion criteria (11 listed)
- Patients with previously failed therapy with protease inhibitors (PI) or those receiving sub optimum therapy with nucleoside analogue reverse transcriptase inhibitors (NRTI) for the study disease.
- Presence of lipoatrophy defined by the investigator (any grade) or by the patient (in this case, at least two sites of mild degree or one of at least moderate degree).
- Known history of drug addiction or chronic use of alcohol that, in the investigator's opinion, contraindicates participation in the study.
- Pregnant or nursing women or women of child bearing age not using an adequate contraceptive method according to the investigator's criterion.
- Current active opportunistic infection or documented infection in the 4 weeks prior to screening.
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 |
|---|---|---|
| AZT+3TC+ABV (Trizivir)Also: LPV/r (Kaletra)Patients on treatment with TZV and viral suppression will be randomized to keep on TZV vs switching to LPV/r monotherapy | Drug | 2 |
| Switching to LPV/r monotherapy (Kaletra)Also: KaletraPatients on AZT+3TC+ABV with viral suppression will be randomized to keep on vs switching to LPV/r | Drug | 2 |
Primary outcome
Limb Fat changes measured by DEXA
Time frame: 48 weeks
3 secondary outcomes
20 % loss peripheral fat measured by DEXA
Time frame: 96 weeks
Perception of change on body fat by physician and patient.
Time frame: 96 weeks
Lipohypertrophy
Time frame: 96 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 12 Sep 2013.
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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.
Jose Antonio Iribarren study chair
Hospital de Donostia
7 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 AZT+3TC+ABV (Trizivir) and Switching to LPV/r monotherapy (Kaletra) in people with HIV Infection and HIV Infections, run by Fundacion SEIMC-GESIDA at 7 sites in Spain.
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 11 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 12 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. 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?
Limb Fat changes measured by DEXA (time frame: 48 weeks). 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 12 Sep 2013.