A Phase IV, Open-Label, Randomized, Multicenter Trial Assessing the Efficacy of a Treatment Maintenance Phase with Unboosted vs. Boosted Reyataz After an Induction Phase with Reyataz and Ritonavir in Treatment Naive HIV Patients+ Protocol Amendment 1: Pharmacogenetics Blood Sample Amendment dated 03-Jun-2005 - The INDUMA Study

Overview

No summary available.

Registry

who.int

Start Date

October 10, 2005

End Date

January 30, 2008

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\) Written informed consent
•2\) Treatment naïve HIV\-1 infected subjects ( \< 10 days of treatment with any ARV).
•3\) Subjects who have an HIV\-1 RNA level \= 5000 c/mL at screening.
•4\) Subjects who have a CD4 count \= 50 cells/mm3\.
•5\) Men and women, ages 18 years of age or older (or minimum age as determined by
•local regulatory or as legal requirements dictate).
•6\) Both females of child\-bearing potential and males must utilize effective barrier
•contraception.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•1\) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study.
•2\) Women who are pregnant or breastfeeding
•3\) Presence of a newly diagnosed HIV\-related opportunistic infection or any medical
•condition requiring acute therapy at the time of enrollment
•4\) Primary HIV infection
•5\) Subjects with known Gilbert’s syndrome
•6\) Active alcohol or substance use sufficient, in the investigator’s opinion, to prevent
•adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis
•7\) Screening laboratory values measured as follows:
•a) Grade IV glucose,