Clinical Trial to Assess the Effect of the Change of Efavirenz (EFV) for Lopinavir/Ritonavir (LPV/r) in Lipoatrophy in HIV-infected Patients

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Brief Title

Clinical Trial to Assess the Effect of the Change of Efavirenz (EFV) for Lopinavir/Ritonavir (LPV/r) in Lipoatrophy in HIV-infected Patients

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.

Brief Summary

      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.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Absolute change in limb fat mass measured by DEXA.

Condition

HIV Infections

Intervention

EFV

Study Arms / Comparison Groups

 EFV and Fixed combinations of analogues
Description:  EFV + Fixed combinations of analogue tenofovir + emtricitabine, or abacavir + lamivudine

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

20

Start Date

October 2009

Completion Date

November 2013

Primary Completion Date

November 2013

Eligibility 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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Spain

Location Countries

Spain

Administrative Informations

NCT ID

NCT00978237

Organization ID

LIPOKAL

Responsible Party

Sponsor-Investigator

Study Sponsor

Juan A. Arnaiz

Study Sponsor

, ,

Verification Date

September 2014