Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl

HIV Infections Clinical Trial

— ADVANZ-3  

Official title:

Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl. A Prospective, Randomized, Multicentre, Open Clinical Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00532168
• Other study ID #: ADVANZ-3
• Secondary ID: EudraCT: 2006-00
• Status: Completed
• Phase: Phase 4
• First received: September 18, 2007
• Last updated: February 21, 2013
• Start date: September 2007
• Est. completion date: December 2012

Study information

• Verified date: February 2013
• 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

There are few randomized clinical trials in advanced HIV patients. This is a multicenter, randomized, open clinical trial, comparing three parallel groups, to compare the immunological reconstitution and the virological efficacy and safety of three different combinations of antiretroviral therapy given once a day (QD): tenofovir plus emtricitabine plus either efavirenz, lopinavir-ritonavir or atazanavir-ritonavir during 96 weeks in advanced antiretroviral naïve HIV-1 infected patients with less than 100 CD4+ T-cells/mm3. Primary endpoint is the median increase in CD4+ T-cell count at 48 weeks after starting HAART.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic HIV-1 infection

• Age 18 or more

• Antiretroviral-naive

• Baseline CD4+ count <100 cels/mcL.

• No mutations of drug resistance at baseline (M184V/I, K65R, resistance to efavirenz or 2 or more PRAMs (L33I/F/V, V82A/F/L/T, I84V, L90M)

• Written informed consent

Exclusion Criteria:

• Hypersensibility to study drugs.

• Pregnancy or breastfeeding

• Active OI requiring admission

• Active lymphoma or malignancy (Kaposi sarcoma included)

• Cl creatinine below 30 ml/min.

• Liver failure

• Treatment with nephrotoxic drugs, immunomodulators, interleukine-2, systemic steroids or investigational products.

Study Design

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• tenofovir + emtricitabine + efavirenz
tenofovir + emtricitabine + efavirenz, approved dose, oral route, QD
• tenofovir + emtricitabine + lopinavir-ritonavir
tenofovir + emtricitabine (QD) + lopinavir-ritonavir (BID), oral route, approved dose
• tenofovir + emtricitabine + atazanavir-ritonavir
tenofovir + emtricitabine + atazanavir + ritonavir (100 mg), oral route, approved dose, QD

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Juan A. Arnaiz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median increase in CD4+ T-cell count at 48 weeks after starting the HAART combination randomly assigned		48 weeks	No