Analysis of Changes in Adipose Tissue of Patients With Lipoatrophy HIV Infection Treated With Nucleoside Thymidine, After Switching to Monotherapy With Lopinavir / Ritonavir (BIOKAL)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01031849 |
Recruitment Status
:
Terminated
(patient sample not reached)
First Posted
: December 15, 2009
Last Update Posted
: April 8, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Kaletra | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
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 |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | October 2012 |
Actual Study Completion Date : | November 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Kaletra, all patients
Patients will change actual treament for monotherapy LPV/r. They only will take Kaletra 2/day
|
Drug: Kaletra
Each tablet of Kaletra contains 200 mg of Lopinavir and 50mg of ritonavir. The patients will take two tablets of Kaletra bid.
|
- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01031849
Spain | |
Fundación Jiménez Díaz | |
Madrid, Spain, 28040 | |
Hospital Clínico San Carlos | |
Madrid, Spain, 28040 |
Principal Investigator: | Vicente Estrada, MD | hospital Clínico San Carlos, Madrid |
Responsible Party: | Ines Perez, MD, Hospital San Carlos, Madrid |
ClinicalTrials.gov Identifier: | NCT01031849 History of Changes |
Other Study ID Numbers: |
HCSKAL-2009-01 2009-016090-14 ( Other Identifier: EudraCT Number ) |
First Posted: | December 15, 2009 Key Record Dates |
Last Update Posted: | April 8, 2013 |
Last Verified: | April 2013 |
Keywords provided by Ines Perez, Hospital San Carlos, Madrid:
HIV 1 patients |
Additional relevant MeSH terms:
Infection HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Ritonavir Lopinavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |