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

NCT01829802 | Unknown Phase 4

• 2 other identifiers: FH-1450250
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Infection With HIV

Keywords

HIV; Raltegravir; Boosted atazanavir

Outcome Measures

Primary Outcomes (2)

• Proportion of subjects with plasma HIV-1 RNA below the limit of detection (<50 copies/mL)in an intention to treat (exposed) analysis.

  48 weeks

• Proportion of subjects with SAEs and proportion with AEs leading to discontinuation.

  Through week 48

Secondary Outcomes (3)

• Change from baseline on viral load

  24 and 48 weeks

• Change from baseline in lipid profile and renal function

  Through 48 weeks

• Change from baseline in inflammation markers

  24 and 48 weeks

Other Outcomes (1)

• Number and type of resistance mutations in case of virologic failure

  Through 48 weeks

Study Arms (2)

RAL+ATA/r

EXPERIMENTAL

Raltegravir 400 mg BID plus Ritonavir Boosted Atazanavir 300/100 mg QD

Drug: Ritonavir boosted Atazanavir; Drug: Raltegravir

TDF/FTC (or 3TC) +ATA/r

ACTIVE COMPARATOR

TDF/FTC (or 3TC)- Fixed dose combination of Tenofovir 300 mg plus Emtricitabine 200 mg (or Lamivudine 300 mg) QD plus Ritonavir Boosted Atazanavir 300/100 mg QD

Drug: Ritonavir boosted Atazanavir; Drug: TDF/FTC (or 3TC)

Interventions

Ritonavir boosted Atazanavir DRUG

Ritonavir boosted Atazanavir 300/100 mg QD in combination with other drugs

Also known as: Reyataz, Norvir

RAL+ATA/r; TDF/FTC (or 3TC) +ATA/r

Raltegravir DRUG

Raltegravir 400 BID in combination with Ritonavir boosted Atazanavir 300/100 mg QD during 48 weeks

Also known as: Isentress

RAL+ATA/r

TDF/FTC (or 3TC) DRUG

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

Also known as: Truvada, TDF-FTC, TDF-3TC, Mivuten

TDF/FTC (or 3TC) +ATA/r

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subject ≥18 years of age.
• Documented HIV-1 infection defined as a positive ELISA plus a confirmatory Western Blot; or a plasma HIV-1 RNA ≥10,000 copies/mL ever documented.
• Patients who have failed their initial treatment containing NNRTI(s) + 2NRTI(s) combination therapy, according to virological criteria defined by two consecutive (at least 7 days apart) HIV-1 RNA results ≥500 copies/mL. Subject must be on stable HAART for at least the last 4 weeks.
• No prior or current exposure to HIV-1 protease inhibitors and/or HIV-1 integrase inhibitors.
• Subject must have susceptibility to ATV/r and TDF, as resulted by resistance testing at screening. RAL sensitivity is not required for patients never exposed to this drug in the country.
• Subject has voluntarily signed ICF.
• Subject can comply with protocol requirements.
• Subject's general medical condition, in the investigator's opinion, does not interfere with assessments and completion of the trial.
• Subject agrees not to take any medication during the study, including over the counter medicines or herbal preparations, without the approval of the trial physician.
• If female, is not breastfeeding or pregnant.
• If female, subject must be either postmenopausal for at least one year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or she must use 2 different methods of birth control including, at least, one barrier method, that are acceptable to both the subject and investigator, and willing to continue their use for at least 30 days after the end of the treatment period.
• Subjects must have a life-expectancy of more than 1 year.

You may not qualify if:

• Patient has a current (active) diagnosis of acute hepatitis due to any cause OR chronic hepatitis B and/or C WITH aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>2.5 x upper limit of normal (ULN) AND/OR is likely to require hepatitis treatment in the next year.
• Active hepatitis B infection (positive HBsAg), regardless of stage of infection.
• Subject has a currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV infection 1993) in the last 30 days.
• Subjects with a laboratory abnormality Grade 3 or 4 with the following exceptions: pancreatic amylase, cholesterol, triglycerides, gamma glutamyl transpeptidase.
• Screening laboratory analysis show any of the following abnormal results:
• Hemoglobin \<8.0 g/dL
• Absolute neutrophil count \<750 cells/µL
• Platelet count \<50,000 mm3
• Creatinine \>1.5 x ULN
• Any condition that, in the investigators opinion, could compromise the subject's safety or adherence to the trial protocol.
• The use of any study agent within 30 days prior to screening.
• Use of immunosuppressive drugs, cytokines inhibitors or other cytokines in the previous year.
• Any other condition (including, without limitation, the use of alcohol or drugs) that in the investigator's opinion may compromise the safety of the patient or his/her adherence to the protocol.

Sponsors & Collaborators

• Pedro Cahn: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Fundacion Huesped

Buenos Aires, Buenos Aires, C1202ABB, Argentina

Location

Dra Luna Norma

Córdoba, Córdoba Province, 5000, Argentina

Location

MeSH Terms

Interventions

Atazanavir Sulfate; Ritonavir; Raltegravir Potassium; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Pyrrolidinones; Pyrrolidines; Tenofovir; Organophosphonates; Organophosphorus Compounds; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Pedro Cahn, MD

  Fundación Huésped

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 11, 2013
• Study Start: May 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

AR (2)