DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Induction-Maintenance With Atazanavir in HIV Naïve Patients (The INDUMA Study)

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Atazanavir + 2 NRTIs (Drug); Atazanavir + Ritonavir + 2 NRTIs (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

The purpose of this study is to compare the proportion of subjects with HIV-1 RNA viral load < 50 c/mL through Week 48 of the Maintenance Phase among HIV-infected subjects with an initial undetectable viral load following an Induction Phase with an ATV/RTV containing HAART regimen, when switched to ATV versus remaining on ATV/RTV, whilst continuing their previous NRTI backbone.

Clinical Details

Official title: 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 (the INDUMA Study)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Participants With HIV-1 RNA <50 Copies/mL (c/mL) Through Week 48 of the Maintenance Phase

Secondary outcome:

Percentage of Participants With HIV-1 RNA <400 c/mL Through Week 48 of the Maintenance Phase

Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥50 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase

Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥400 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase

Change From End of Induction Phase in CD4 Cell Count at Week 48 of Maintenance Phase

Change From Baseline in CD4 Cell Count at Week 24 of Induction Phase

Change From Baseline in CD4 Cell Count at Week 48 of Rescue Phase

Change From Baseline in HIV-1 RNA at Week 24 of the Induction Phase

Change From Baseline in HIV-1 RNA at Week 48 of the Rescue Phase

Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥50 c/mL) Through the End of Rescue Phase

Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥400 c/mL) Through the End of Rescue Phase

Time to Suppression (Confirmed HIV-1 RNA < 50 c/mL) During Treatment Phase

Time to Suppression (Confirmed HIV-1 RNA < 400 c/mL) During Treatment Phase

Summary of Adverse Events During Induction Phase

Summary of Adverse Events During Maintenance Phase

Summary of Adverse Events During Rescue Phase

Percent Change From End of Induction Phase in Fasting Lipids at Week 48 of Maintenance Phase

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Treatment naive HIV-1 infected subjects ( < 10 days of treatment with any ARV).

- Subjects who have an HIV-1 RNA level ≥ 5000 c/mL at screening.

- Subjects who have a CD4 count ≥ 50 cells/mm3.

- Men and women, ages 18 years of age or older (or minimum age as determined by local

regulatory or as legal requirements dictate).

- Both females of child-bearing potential and males must utilize effective barrier

contraception. Other contraception in addition to barrier methods is permitted; refer to the Investigator Brochure for details regarding potential interactions with ATV and some oral contraceptives Exclusion Criteria:

- 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.

- WOCBP using a prohibited contraceptive method. Caution is warranted with

coadministration of oral contraceptives (ethinyl estradiol and norethindrone) - see

Investigator Brochure for details

- Women who are pregnant or breastfeeding

- Women with a positive pregnancy test on enrollment or prior to study drug

administration.

- Presence of a newly diagnosed HIV-related opportunistic infection or any medical

condition requiring acute therapy at the time of enrollment

- Primary HIV infection

- Medical History and Concurrent Diseases

- 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 Physical and Laboratory Test Findings

- Screening laboratory values measured as follows:

- Grade IV glucose,

- Grade IV electrolytes,

- Grade IV transaminases,

- Grade IV hematology.

- Hypersensitivity to any component of the formulation of study drug

- Prior history of taking any ARV for more than 10 days

- Concomitant administration of tenofovir (TDF).

- Refer to Section 6. 4.1 which details all prohibited therapies

Locations and Contacts

Local Institution, Tallinn, Estonia

Local Institution, Le Kremlin Bicetre 94, France

Local Institution, Orleans, France

Local Institution, Paris Cedex 12, France

Local Institution, Paris Cedex 20, France

Local Institution, Paris, France

Local Institution, Suresnes, France

Local Institution, Dusseldorf, Germany

Local Institution, Hannover, Germany

Local Institution, Stuttgart, Germany

Local Institution, Ulm, Germany

Local Institution, Brescia, Italy

Local Institution, Milano, Italy

Local Institution, Napoli, Italy

Local Institution, Padova, Italy

Local Institution, Riga, Latvia

Local Institution, Cascais, Portugal

Local Institution, Porto, Portugal

Local Institution, Moscow, Russian Federation

Local Institution, Smolensk, Russian Federation

Local Institution, St. Petersburg, Russian Federation

Local Institution, Barcelona, Spain

Local Institution, Madrid, Spain

Local Institution, Valencia, Spain

Local Institution, Elche, Alicante, Spain

Local Institution, Bristol, Avon, United Kingdom

Local Institution, Edinburgh, Central, United Kingdom

Local Institution, Dublin 3, Dublin, Ireland

Local Institution, Dublin 8, Dublin, Ireland

Local Institution, London, Greater London, United Kingdom

Additional Information

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: November 2005
Last updated: January 7, 2010

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017