Study to Evaluate the Activity and Tolerability of Lopinavir/Ritonavir and Lamivudine Bitherapy in HIV Patients With Viral Suppression

HIV Infection Clinical Trial

— OLE  

Official title:

Study to Evaluate the Activity and Tolerability of Lopinavir/Ritonavir and Lamivudine Bitherapy Instead of a Triple Therapy That Includes Lopinavir/Ritonavir and Lamivudine or Emtricitabine in HIV Patients With Viral Suppression: Controlled Clinical Trial, Open Label, Randomized, of 48 Weeks of Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01471821
• Other study ID #: OLE
• Status: Completed
• Phase: Phase 4
• First received: November 15, 2011
• Last updated: July 28, 2014
• Start date: October 2011
• Est. completion date: April 2014

Study information

• Verified date: July 2014
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

This is a prospective, open controlled trial in which HIV-1 with viral suppression patients will be randomized to continue with their current treatment (lopinavir/ritonavir plus emtricitabine or lamivudine plus any nucleoside analogue reverse transcriptase inhibitor) or to simplify to lopinavir/ritonavir plus lamivudine.

Randomization will be stratified according to the values of nadir CD4 and time of viral suppression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients of either sex (female or male) and 18 years or older.

• Patients seropositive for HIV-1 using standard diagnostic criteria.

• There is confirmation of viral load to be lower than 50 cop/ml during the 6 previous months to inclusion. The requirement is to have at least two viral loads lower than 50 cop/mL separated by 6 months and no one >50cop/mL during the 6 months before inclusion.

• Patients on continuous HAART consisting of LPV/r, emtricitabine (FTC) or 3TC (lamivudine) and an NRTI for at least 2 months before being randomized in this study.

• Patients who are clinically stable, in the opinion of the investigator, at entry into the study (clinical status and chronic medication must not have not been modified at least 14 days prior to randomization). Patients receiving therapy for an active opportunistic infection are eligible for enrollment if the above criteria are met. Standard prophylaxis of opportunistic infections is permitted.

Exclusion Criteria:

• Pregnancy, nursing, or planned pregnancy during the study period.

• Previous failure with regimens including a protease inhibitor (PI) or 3TC/FTC.

• Known resistance mutations to PIs or 3TC/FTC.

• Patients with an active opportunistic infection or malignancy. Patients with a stable chronic opportunistic infection may be included in the study.

• Any disease or history of disease which, in the opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment.

• Patients diagnosed with visceral Kaposi's sarcoma (KS), patients with lymphoedema secondary to cutaneous KS or cutaneous or palatine KS who have been treated with systemic immunosuppressive therapy must also be excluded.

• Patients with chronic hepatitis B on treatment with tenofovir + 3TC/FTC

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infection

Intervention

Drug:
• antiretroviral treatment
antiretroviral treatment

Locations

Country	Name	City	State
Spain	Hospital Clínic i Provincial Barcelona	Barcelona
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Juan A. Arnaiz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with no treatment failure	viral failure, defined as two viral loads above 50 copies/ml at least two weeks apart; death; developing new CDC-C events; withdrawing consent; being lost to follow-up; switching assigned treatment for any cause	48 weeks	No
Secondary	Proportion of patients with no viral failure	defined as two viral loads above 50 copies/ml. Patients lost to follow-up or changing treatment will not be taken into account for this analysis	48 weeks	No
Secondary	Proportion of patients with no therapeutical failure	defined as in the primary outcome but with two viral loads above 400 copies/ml, not 50 as in the primary outcome.	48 weeks	No
Secondary	Proportion of patients with no viral failure	defined as two viral loads above 400 copies/ml	48 weeks	No
Secondary	Time to viral failure	Two different analysis will be carried out: with 50 copies/ml threshold and with 400 copies/ml threshold	48 weeks	No
Secondary	Proportion of patients with blips	Defined as one viral load above 50 and below 400 copies/ml with next viral load below 50 copies/ml	48 weeks	No
Secondary	Change from baseline CD4		48 weeks	No
Secondary	Lipidic profile change from baseline		48 weeks	Yes
Secondary	Creatinine clearance change from baseline		48 weeks	Yes
Secondary	Proportion of patients with proximal tubular renal disfunction		48 weeks	Yes
Secondary	Lipodystrophy changes from baseline	evaluated using two questionnaires: lipoatrophy and fat accumulation	48 weeks	Yes
Secondary	Adherence to treatment		48 weeks	No
Secondary	Mortality and progression to AIDS		48 weeks	No
Secondary	Adverse events per treatment branch		48 weeks	Yes
Secondary	Proportion of patients switching study treatment due to an adverse event		48 weeks	Yes
Secondary	Proportion of serious adverse events related to treatment		48 weeks	Yes