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

HIV Infections Clinical Trial

— INDUMA  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00207142
• Other study ID #: AI424-136
• Status: Completed
• Phase: Phase 4
• First received: September 16, 2005
• Last updated: January 7, 2010
• Start date: November 2005
• Est. completion date: January 2008

Study information

• Verified date: January 2010
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: January 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Atazanavir + 2 NRTIs
Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs)
• Atazanavir + Ritonavir + 2 NRTIs
Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs)

Locations

Country	Name	City	State
Estonia	Local Institution	Tallinn
France	Local Institution	Le Kremlin Bicetre 94
France	Local Institution	Orleans
France	Local Institution	Paris
France	Local Institution	Paris Cedex 12
France	Local Institution	Paris Cedex 20
France	Local Institution	Suresnes
Germany	Local Institution	Dusseldorf
Germany	Local Institution	Hannover
Germany	Local Institution	Stuttgart
Germany	Local Institution	Ulm
Ireland	Local Institution	Dublin 3	Dublin
Ireland	Local Institution	Dublin 8	Dublin
Italy	Local Institution	Brescia
Italy	Local Institution	Milano
Italy	Local Institution	Napoli
Italy	Local Institution	Padova
Latvia	Local Institution	Riga
Portugal	Local Institution	Cascais
Portugal	Local Institution	Porto
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Smolensk
Russian Federation	Local Institution	St. Petersburg
Spain	Local Institution	Barcelona
Spain	Local Institution	Elche	Alicante
Spain	Local Institution	Madrid
Spain	Local Institution	Valencia
United Kingdom	Local Institution	Bristol	Avon
United Kingdom	Local Institution	Edinburgh	Central
United Kingdom	Local Institution	London	Greater London

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Estonia,  France,  Germany,  Ireland,  Italy,  Latvia,  Portugal,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With HIV-1 RNA <50 Copies/mL (c/mL) Through Week 48 of the Maintenance Phase		From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase	No
Secondary	Percentage of Participants With HIV-1 RNA <400 c/mL Through Week 48 of the Maintenance Phase		From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase	No
Secondary	Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA =50 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase		Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48	No
Secondary	Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA =400 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase		Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48	No
Secondary	Change From End of Induction Phase in CD4 Cell Count at Week 48 of Maintenance Phase		End of Induction Phase (Week 26 to Week 30 of Induction Phase treatment), Week 48 of Maintenance Phase	No
Secondary	Change From Baseline in CD4 Cell Count at Week 24 of Induction Phase		Baseline, Week 24 of Induction Phase	No
Secondary	Change From Baseline in CD4 Cell Count at Week 48 of Rescue Phase		Baseline, Week 48 of Rescue Phase	No
Secondary	Change From Baseline in HIV-1 RNA at Week 24 of the Induction Phase		Baseline, Week 24 of Induction Phase	No
Secondary	Change From Baseline in HIV-1 RNA at Week 48 of the Rescue Phase		\Baseline, Week 48 of Rescue Phase	No
Secondary	Treatment Outcomes Based on Viral Loads (HIV-1 RNA =50 c/mL) Through the End of Rescue Phase		Through Week 48 of Rescue Phase. Measurements were included from the end of Induction Phase through the last dose of Rescue Phase study therapy plus 4 days.	No
Secondary	Treatment Outcomes Based on Viral Loads (HIV-1 RNA =400 c/mL) Through the End of Rescue Phase		Baseline, Week 48 of Rescue Phase	No
Secondary	Time to Suppression (Confirmed HIV-1 RNA < 50 c/mL) During Treatment Phase		Week 16-18, Week 24-26, Week 38-40, Week 64-66	No
Secondary	Time to Suppression (Confirmed HIV-1 RNA < 400 c/mL) During Treatment Phase		Week 16-18, Week 24-26, Week 30-32	No
Secondary	Summary of Adverse Events During Induction Phase		Measurements are included through the earlier of the last dose of Induction Phase study therapy plus 30 days or the first dose of Maintenance/Rescue Phase therapy (ie, up until 26 to 31 weeks + 30 days).	Yes
Secondary	Summary of Adverse Events During Maintenance Phase		Measurements are included from the end of Induction Phase (26 to 30 weeks after first dose) through the last dose of Maintenance Phase study therapy plus 30 days.	Yes
Secondary	Summary of Adverse Events During Rescue Phase		Measurements are included from the end of Induction Phase (26 to 30 weeks after the first dose therapy) through the last dose of Rescue Phase study therapy plus 30 days.	Yes
Secondary	Percent Change From End of Induction Phase in Fasting Lipids at Week 48 of Maintenance Phase		Measurements were included from the end of Induction Phase (Week 26 to Week 30 of Induction therapy) through Week 48 of Maintenance Phase.	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm