Lopinavir/r Monotherapy Versus Abacavir/Lamivudine and Lopinavir/r for Limb Fat Recovery in Persons With Lipoatrophy (KRETA)
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|ClinicalTrials.gov Identifier: NCT00865007|
Recruitment Status : Completed
First Posted : March 19, 2009
Last Update Posted : March 22, 2013
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|Condition or disease||Intervention/treatment||Phase|
|HIV Infection Lipodystrophy HIV Infections||Drug: Monotherapy (Lopinavir/ritonavir) Drug: Monotherapy (Lopinavir/ritonavir) + ABC/3TC||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IV-III Comparative, Randomized, Open-label Study to Evaluate the Efficacy for the Recovery of Peripheral Fat (or of the Extremities) of Lopinavir/Ritonavir in Monotherapy Versus Abacavir/Lamivudine and Lopinavir/Ritonavir|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||September 2012|
Experimental: Monotherapy group
Drug: Monotherapy (Lopinavir/ritonavir)
Active Comparator: Triple arm
Lopinavir/ritonavir (LPV/r)+ ABC/3TC
Drug: Monotherapy (Lopinavir/ritonavir)
Drug: Monotherapy (Lopinavir/ritonavir) + ABC/3TC
NRTI sparing regimen
- Absolute change in limb fat measured by DEXA at 48w [ Time Frame: 48 weeks ]
- Absolute change in limb-fat measured by DEXA at 96 weeks [ Time Frame: 96 weeks ]
- Lipid changes at Week 24, 48, 72 and 96 [ Time Frame: 96 weeks ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Confirmation of the willingness of the patient to participate in this study after being informed on all the aspects of the trial that may influence their decision, signing and dating the written informed consent form approved by the Ethics Committee.
- The patient is 18 years of age or older.
- (Documented) HIV-1 infection.
- Receiving treatment with ZDV+3TC+ABC (in continuous antiretroviral treatment, without discontinuation periods, for the past 6 months).
- There is confirmation that during the 6 months prior to inclusion in the study the viral burdens were below 50 copies/mL.
- A viral burden below 50 copies/mL no more than 30 days before starting the study.
- No previous history of virological failure while on antiretroviral treatment with protease inhibitors (PIs). That is, they have never switched protease inhibitors for suspected or documented virological failure. The changes in protease inhibitor due solely to toxicity, simplification or optimization are acceptable.
- Clinical evidence of moderate to severe lipoatrophy (according to the case definition as scoring >- 2. For inclusion in the study, the subject should have moderate to severe lipoatrophy in at least one site, and defined by the physician.
- Absence of signs of acute disease.
- Patient has not been treated for an active opportunistic infection within the 30 days prior to the baseline visit.
- Patient with Karnofsky index >- 70.
- During the study, the patient does not require and agrees not to take any of the following drugs that are contraindicated with LPV/r: astemizole, terfenadine, midazolam, triazolam, cisapride, certain ergot derivatives (ergotamine, dihydroergotamine, ergonovine, methylergonovine), pimozide, propafenone, and flecainide. Rifampin, a potent enzyme inducer, should not be administered with the study medication due to the possibility of a significant decrease in LPV/r concentrations during concomitant administration, nor drugs contraindicated with 3TC and ABC that in principle should not be being taken, as they are part of the treatment at the screening.
- Patient agrees not to take any medication, including over-the-counter medicines, alcohol, drugs, or herbal preparations without the knowledge and approval of the principal investigator.
- Laboratory tests have been performed on the patients in the past 30 days:
- G/dL hemoglobin >8.0
- Absolute neutrophil count 750 cells/microl
- Platelet count 20,000/microl
- ALT or AST <5 x upper normal limit (UNL)
- Creatinine <1. 5 x UNL
- Triglycerides <750 mg/dL.
- For women, a negative result of a pregnancy test is available and they agree to use throughout the study a barrier contraceptive method of proven reliability in the investigator's opinion.
- Patients with a history of virological failure on treatment with PIs; that is, that they have at some point switched to PIs for confirmed or documented virological failure.
- Patients with positive serum hepatitis B surface antigen.
- Patients requiring treatment with drugs where combination with LPV/r is contraindicated.
- Presence of active opportunistic disease or wasting syndrome or under antitumoral treatment with chemotherapy.
- Patients treated in the previous 16 weeks with agents susceptible to insulin (glitazones or metformin), anabolic steroids, growth hormone or any agent that could interfere with the study drugs.
- Active drug addiction or psychiatric disease that may prevent protocol compliance. Use of cannabis or being on methadone treatment are excepted, provided protocol compliance is not compromised in the investigator's opinion.
- Pregnant women or nursing mothers, and women of childbearing age if they do not agree to use a barrier contraceptive method throughout the study of proven reliability in the investigator's opinion.
- In the opinion of the principal investigator, the patient is unlikely to comply with the study protocol, or the patient is not eligible for any other reason.
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): NCT00865007
|Hospital Severo Ochoa|
|Leganes, Madrid, Spain, 28911|
|Hospital Xeral Cies|
|Vigo, Pontevedra, Spain, 36204|
|Hospital de Donostia|
|Donostia, San Sebastian, Spain, 20014|
|Hospital de Basurto|
|Bilbao, Vizcaya, Spain, 48013|
|Hospital General Universitario de Alicante|
|Alicante, Spain, 03010|
|Hospital Sant Creu i Sant Pau|
|Barcelona, Spain, 08025|
|Hospital Clinico y Provincial|
|Barcelona, Spain, 08036|
|Hospital Universitario Reina Sofia|
|Cordoba, Spain, 14004|
|Hospital La Paz|
|Madrid, Spain, 28006|
|Hospital Doce de Octubre|
|Madrid, Spain, 28041|
|Hospital La Paz|
|Madrid, Spain, 28046|
|Study Chair:||Jose Ignacio Bernardino||Hospital La Paz|
|Study Chair:||Jose Ramon Arribas||Hospital La Paz|
|Responsible Party:||Fundacion SEIMC-GESIDA|
|Other Study ID Numbers:||
2008-003748-12 ( EudraCT Number )
|First Posted:||March 19, 2009 Key Record Dates|
|Last Update Posted:||March 22, 2013|
|Last Verified:||March 2013|
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
RNA Virus Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Skin Diseases, Metabolic
Lipid Metabolism Disorders
HIV Protease Inhibitors
Viral Protease Inhibitors
Molecular Mechanisms of Pharmacological Action