To Evaluate Effectiveness and Safety of Containing Raltegravir in Naive HIV NON B or B Infected Patients

NCT01162538 | Unknown

• 1 other identifier: 2010-021178-12
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Pilot open label multicentric study

Conditions

Evaluated; Non B Subtype; Naive Patients

Keywords

Raltegravir, non B subtype, naive patients

Eligibility Criteria

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

Study Population

It's a pilot open label, multicentric, national, prospective and descriptive study to evaluate effectiveness and safety of regimen containing Raltegravir (400mg x 2) in 40 treatment naive HIV non B infected subjects versus in 20 treatment naive HIV B infected sujects. The patients will be matched according to: * basal viral load (\< 10 000 copies/ml, ≥100 000 copies/ml) * rate of basal CD4 (\<200 cell/mm3, ≥ 200 cell/mm3)

You may qualify if:

• In order to be eligible to take part in this study, patients should meet all of the following criteria:
• Patient aged at least 18 years; Treatment naive patient infected with HIV-1; Patients indicated for treatment containing raltegravir Patient has at least 2 activates molecules in combination therapy according genotype realized in the visit of selection.
• Patient has not a history or current evidence of opportunist infection within the 4 weeks before the selection Patient who has received oral and written (information sheet) information about the study and who has agreed for the computer processing of his/her personal data.
• Patients with chronic hepatitis, including chronic hepatitis B and/or C may enter the study as.

You may not qualify if:

• Patients meeting one or both of the following criteria may not take part in the study
• Patient is reproductive potential without requiring the use of contraception
• Patient is pregnant or breast-feeding
• Patient using alcohol and\\or drug and\\or the other substance that might interfere with the patient participation
• Patient infected by HIV2
• Patient has severe hepatic insufficiency. (liver enzymes \> 5N)
• Patient has the following laboratory values during selection
• Platelets \< 40.000 cell / mm3
• Haemoglobin \< 8 g / dl during the selection
• Neutrophils \< 500 / mm3
• Patient has associated treatments which can have interactions with Raltegravir (Cf RCP Isentress ®)
• Patient should be considered by the investigator able to conform to the imperatives of the study procedures

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Robert Ballanger: lead

Study Sites (1)

Hopital R.Ballanger

Aulnay-sous-Bois, 93602, France

Location

Study Officials

• Delassus Jean-Luc, MD

  Réseau Aulnay 93

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 9, 2010
• First Posted: July 14, 2010
• Study Start: September 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2012
• Last Updated: July 14, 2010

Record last verified: 2010-05

Locations

FR (1)