Clinical Trial to Assess the Effect of the Change of Efavirenz (EFV) for Lopinavir/Ritonavir (LPV/r) in Lipoatrophy in HIV-infected Patients (LIPOKAL)
This study is ongoing, but not recruiting participants.
Sponsor:
Juan A. Arnaiz
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00978237
First received: September 15, 2009
Last updated: February 21, 2013
Last verified: February 2013
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Purpose
Eligible HIV-infected patients with clinically evident lipoatrophy despite treatment with efavirenz and fixed-dose combination of thymidine nucleoside analogues will be informed and asked to enroll in the study; will be randomized (1:1) into two branches, A: EFV + Fixed combinations of analogue tenofovir + emtricitabine.B (experimental): LPV/r + combination of correspondent analogues. The main variable is the evaluation of the absolute change in limb fat mass at 24 months from baseline in both groups.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Lipoatrophy |
Drug: EFV Drug: LPV/r |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | CT to Assess the Effect on the Subcutaneous Fat of Change of EFV for LPV/r in HIV-infected Patients Who Developed Lipoatrophy and Remains Despite Treatment With Efavirenz and Fixed-dose Combination of no Thymidine Nucleoside Analogues. |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Efavirenz
U.S. FDA Resources
Further study details as provided by Hospital Clinic of Barcelona:
Primary Outcome Measures:
- Absolute change in limb fat mass measured by DEXA. [ Time Frame: 24 months. ] [ Designated as safety issue: Yes ]
| Enrollment: | 20 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: EFV and Fixed combinations of analogues
EFV + Fixed combinations of analogue tenofovir + emtricitabine, or abacavir + lamivudine
|
Drug: EFV
one pill QD VO.
|
| Experimental: LPV/r and combination of analogues. |
Drug: LPV/r
2 pills QD VO
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients HIV positive > 18 years.
- Patients in treatment with Sustiva(r)+Truvada(r); or Sustiva (r)+Kivexa(r).
- HIV-ARN < 50 copies/mL in the las six months.
- Clinically evident lipoatrophy (moderate or severe).
- Negative pregnancy test.
- Signed informed consent.
Exclusion Criteria:
- Evidence of failure or mutation to therapy with protease inhibitors.
- Patients that can not be treated with LPV/r.
- Mild lipoatrophy.
- History of alcoholism or drug addiction that discourages participation in the study.
- Pregnancy or breastfeeding.
- Documented current or 4 weeks prior opportunistic infection.
- Creatinin clearance < 60mL/min.
- Concomitant use of nephrotoxic drugs or immunosuppressants.
- Actual treatment with systemic corticosteroids, IL-2 or chemotherapy.
- Patients under treatment with other drugs in investigation.
- Acute hepatitis.
- Any other disease that discourages participation.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00978237
Locations
| Spain | |
| Hospital de Bellvitge | |
| L'Hospitalet de LLobregat, Barcelona, Spain | |
| Hospital Universitario Central de Asturias | |
| Asturias, Spain | |
| Hospital Clínic de Barcelona | |
| Barcelona, Spain | |
| Hospital de la Santa Creu i Sant Pau de Barcelona | |
| Barcelona, Spain | |
| Hospital Clínico San Carlos | |
| Madrid, Spain | |
| Hospital La Fe | |
| Valencia, Spain | |
| Hospital Xeral-Cíes | |
| Vigo, Spain | |
Sponsors and Collaborators
Juan A. Arnaiz
More Information
No publications provided
| Responsible Party: | Juan A. Arnaiz, MD, PhD, Hospital Clinic of Barcelona |
| ClinicalTrials.gov Identifier: | NCT00978237 History of Changes |
| Other Study ID Numbers: | LIPOKAL |
| Study First Received: | September 15, 2009 |
| Last Updated: | February 21, 2013 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Hospital Clinic of Barcelona:
|
HIV - Lipoatrophy treatment experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lipodystrophy 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 Skin Diseases, Metabolic Skin Diseases |
Lipid Metabolism Disorders Metabolic Diseases Efavirenz Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 19, 2013