NCT01829802

RAL+ATV/r in Comparison With TDF/FTC (or 3TC) +ATV/r in HIV Infected Patients

A Pilot Randomized, Open Label Study to Evaluate Efficacy and Safety of the Combination of RAL+ATV/r in Comparison With TDF/FTC+ATV/r in HIV Infected Patients, Who Failed an Initial NNRTI Containing Regimen

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Pedro Cahn · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this pilot study is to assess the efficacy and safety of the combination of RAL+ATV/r in comparison with TDF/FTC+ATV/r in HIV-1 infected patients presenting virologic failure and PI and TDF naïve.

Detailed description

Overall Study Design and Plan: Description This is a pilot, randomized, open-label study. All the participants will be assigned to receive RAL+ATV/r or TDF/FTC+ATV/r. Patients will be evaluated at screening, randomization (day 0), and on weeks 4, 8, 12, 24, 36 and 48. At the screening visit, subjects must be willing and able to give written (signed and dated) informed consent prior to any study specific procedures. They will receive a unique screening number and will undergo the study procedures associated with the screening visit. The investigator will evaluate whether the subject meets all eligibility criteria specified and record the details of the informed consent process and the results of this assessment in the subject's medical records. Two forms of the ICF will be signed, one for the subject and the other to file at the site. At baseline visit, enrollment criteria will be reviewed and subjects who meet all of them will undergo study procedures. Subjects will receive instructions about study medications and dosing schedule. Subjects should start study medication within 24 hours of the baseline visit. Subjects will return to the investigator´s site for study visits and procedures. Subjects who prematurely discontinue the study must return for a discontinuation visit and undergo the study procedures identified for the discontinuation visit.

Conditions

• Chronic Infection With HIV

Interventions

Type	Name	Description
DRUG	Ritonavir boosted Atazanavir	Ritonavir boosted Atazanavir 300/100 mg QD in combination with other drugs
DRUG	Raltegravir	Raltegravir 400 BID in combination with Ritonavir boosted Atazanavir 300/100 mg QD during 48 weeks
DRUG	TDF/FTC (or 3TC)	Fixed dose combination of Tenofovir 300 mg/Emtricitabine 200 mg or Tenofovir 300 mg/Lamivudine 300 mg plus Ritonavir Boosted Atazanavir 300/100mg given once a day

Timeline

• Start date: 2014-05-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2013-04-11
• Last updated: 2017-01-24

Locations

2 sites across 1 country: Argentina