HIV InfectionsPhase 4BIOKALNCT01031849
Analysis of Changes in Adipose Tissue of Patients With Lipoatrophy HIV Infection Treated With Nucleoside Thymidine, After Switching to Monotherapy With Lopinavir / Ritonavir
A Phase 4 study testing Kaletra in people with HIV Infections, run by Ines Perez at 2 sites in Spain.
Trial summary
The objective is to analyse the changes in the adipose tissue hystological features and the adipogenesis gene expression and related to inflammation after 48 and 96 weeks after the change from AZT+3TC+ABC (Trizivir®) to a monotherapy treatment with LPV/r (Kaletra®) 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?
- Kaletra
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesSpain
- Study dates
- Feb 2010to Nov 2012
- 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 VIH-1, documented with a positive HIV-1 antibody test and/or positive PCR, confirmed for HIV-1 RNA.
- Patients treated with a HAART that should contain AZT+3TC+ABC (Trizivir®)
- Patients with an indetectable viral load, which will be defined <40 copies/mL within the last six months.
- Patients with a lipoatrophy clinical evidence (which will be defined as moderate or severe, according to the Lipodystrophy Severity Grading Scale).
- Men or women aged ≥ 18.
- For women of childbearing potential, negative urine pregnancy test during the Screening visit.
- Patients that have signed and dated the Informed consent Form prior to any Study-specific procedure.
Who cannot join
- Patients with evidence of protease inhibitors failure, and/or documented evidence of protease gene resistance mutation. This evidence could be prior or during the inclusion period in the Study.
- Patients who, for any reason could not be treated with LPV/r.
- Cachexia, defined as an Body Mass Index <17 Kg/m2.
- Pregnant or breastfeeding women, or women of childbearing potential who do not use the appropriate contraceptive method, according to the Investigator judgment.
- Clinically relevant disease or condition, according to the Investigator judgment, three months prior to the patient inclusion in the Study.
- Patients taking the following concomitant medication that could affect the adipocyte function or morphology, such as: insulin, steroids, anabolic steroid, anti-inflammatory medication for more than three months.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Fundación Jiménez Díaz
Madrid, Madrid, 28040
Hospital Clínico San Carlos
Madrid, Madrid, 28040
About this study
Official title: Análisis de Los Cambios en el Tejido Adiposo de Pacientes Con infección VIH y Lipoatrofia en Tratamiento Con análogos de nucleósidos timidínicos, Tras el Cambio a Monoterapia Con Lopinavir/Ritonavir
The objective is to analyse the changes in the adipose tissue hystological features and the adipogenesis gene expression and related to inflammation after 48 and 96 weeks after the change from AZT+3TC+ABC (Trizivir®) to a monotherapy treatment with LPV/r (Kaletra®)
- Conditions
- HIV Infections
- Being tested
- Kaletra
- Keywords
- HIV 1 patients
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KaletraDrug
Each tablet of Kaletra contains 200 mg of Lopinavir and 50mg of ritonavir. The patients will take two tablets of Kaletra bid.
| Study group | Role | What they receive |
|---|---|---|
| Kaletra, all patients | Experimental | Patients will change actual treament for monotherapy LPV/r. They only will take Kaletra 2/day Receives: Drug: Kaletra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in those representative gene expression of adipose tissue toxicity (variable established from those gene involved in adipogenesis, inflammation and metabolism. This gene expression will counted)
Measured: 48 and 96 weeks
Secondary outcomes (3)
Changes in physical fat deposits
Measured: Baseline, 24, 48, 72 and 96 weeks
Changes in leptine and adiponectine plasma levels
Measured: baseline, 24, 48, 72 and 96 weeks
Patients percentage with virologic response (ARN-VIH< 50 copies/mL)
Measured: 48 and 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startFeb 2010
- Primary completionOct 2012
- Study completionNov 2012
Why it stopped: patient sample not reached
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ines Perez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ines Perez, Hospital San Carlos, Madrid
- Investigators
- Vicente Estrada, MD, Principal investigator, hospital Clínico San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031849
- Sponsor's protocol ID
- HCSKAL-2009-01
- Other IDs
- 2009-016090-14, 2009
- Acronym
- BIOKAL
- Status last verified
- Apr 2013
- First submitted
- 4 Dec 2009
- Last updated
- 8 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Análisis de Los Cambios en el Tejido Adiposo de Pacientes Con infección VIH y Lipoatrofia en Tratamiento Con análogos de nucleósidos timidínicos, Tras el Cambio a Monoterapia Con Lopinavir/Ritonavir
- ClinicalTrials.gov ID
- NCT01031849
- Acronym / sponsor ID
- BIOKAL / HCSKAL-2009-01
- Conditions
- HIV Infections
- Keywords
- HIV 1 patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: patient sample not reached
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Ines PerezUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 15 Dec 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 objective is to analyse the changes in the adipose tissue hystological features and the adipogenesis gene expression and related to inflammation after 48 and 96 weeks after the change from AZT+3TC+ABC (Trizivir®) to a monotherapy treatment with LPV/r (Kaletra®)
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kaletra, all patients | Experimental | Drug: KaletraPatients will change actual treament for monotherapy LPV/r. They only will take Kaletra 2/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients infected with VIH-1, documented with a positive HIV-1 antibody test and/or positive PCR, confirmed for HIV-1 RNA.
- Patients treated with a HAART that should contain AZT+3TC+ABC (Trizivir®)
- Patients with an indetectable viral load, which will be defined <40 copies/mL within the last six months.
- Patients with a lipoatrophy clinical evidence (which will be defined as moderate or severe, according to the Lipodystrophy Severity Grading Scale).
- Men or women aged ≥ 18.
Key exclusion criteria (6 listed)
- Patients with evidence of protease inhibitors failure, and/or documented evidence of protease gene resistance mutation. This evidence could be prior or during the inclusion period in the Study.
- Patients who, for any reason could not be treated with LPV/r.
- Cachexia, defined as an Body Mass Index <17 Kg/m2.
- Pregnant or breastfeeding women, or women of childbearing potential who do not use the appropriate contraceptive method, according to the Investigator judgment.
- Clinically relevant disease or condition, according to the Investigator judgment, three months prior to the patient inclusion in the Study.
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 |
|---|---|---|
| KaletraEach tablet of Kaletra contains 200 mg of Lopinavir and 50mg of ritonavir. The patients will take two tablets of Kaletra bid. | Drug | Kaletra, all patients |
Primary outcome
Change in those representative gene expression of adipose tissue toxicity (variable established from those gene involved in adipogenesis, inflammation and metabolism. This gene expression will counted)
Time frame: 48 and 96 weeks
3 secondary outcomes
Changes in physical fat deposits
Time frame: Baseline, 24, 48, 72 and 96 weeks
Changes in leptine and adiponectine plasma levels
Time frame: baseline, 24, 48, 72 and 96 weeks
Patients percentage with virologic response (ARN-VIH< 50 copies/mL)
Time frame: 48 and 96 weeks
Results and safety
The study was stopped early (reason given: patient sample not reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 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.
Vicente Estrada, MD principal investigator
hospital Clínico San Carlos, Madrid
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 Kaletra in people with HIV Infections, run by Ines Perez at 2 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 7 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: stopped early, as of the sponsor's last update on 8 Apr 2013. 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 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 was stopped early (reason given: patient sample not reached). Results are not available in the source record.
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?
Change in those representative gene expression of adipose tissue toxicity (variable established from those gene involved in adipogenesis, inflammation and metabolism. This gene expression will counted) (time frame: 48 and 96 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 8 Apr 2013.