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 version 1.0, dated 03-Jun-05 and, Pharmacogenetics Blood Sample Amendment #01, dated 03-Jun-05 - The INDUMA Study

• Conditions: HIV-infected individuals

• Registration Number: EUCTR2005-000865-21-LV
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-31
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 237

Inclusion Criteria

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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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,
b) Grade IV electrolytes,
c) Grade IV transaminases,
d) Grade IV hematology.
8) Hypersensitivity to any component of the formulation of study drug
9) Prior history of taking any ARV for more than 10 days
10) Concomitant administration of tenofovir (TDF).
11) Any other clinical conditions or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for study or unable to comply with the dosing requirements.
12) Prisoners or subjects who are compulsorily detained

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified