Clinical trial NCT00207142: Induction-Maintenance With Atazanavir in HIV Naïve Patients (The INDUMA Study)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: Treatment Naive
HIV-1 infected treatment naive patients
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With HIV-1 RNA <50 Copies/mL (c/mL) Through Week 48 of the Maintenance Phase
timeFrame: From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase
Secondary outcomes:
measure: Percentage of Participants With HIV-1 RNA <400 c/mL Through Week 48 of the Maintenance Phase
timeFrame: From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase
measure: Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥50 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase
timeFrame: Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48
measure: Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥400 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase
timeFrame: Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48
measure: Change From End of Induction Phase in CD4 Cell Count at Week 48 of Maintenance Phase
timeFrame: End of Induction Phase (Week 26 to Week 30 of Induction Phase treatment), Week 48 of Maintenance Phase
measure: Change From Baseline in CD4 Cell Count at Week 24 of Induction Phase
timeFrame: Baseline, Week 24 of Induction Phase
measure: Change From Baseline in CD4 Cell Count at Week 48 of Rescue Phase
timeFrame: Baseline, Week 48 of Rescue Phase
measure: Change From Baseline in HIV-1 RNA at Week 24 of the Induction Phase
timeFrame: Baseline, Week 24 of Induction Phase
measure: Change From Baseline in HIV-1 RNA at Week 48 of the Rescue Phase
timeFrame: \Baseline, Week 48 of Rescue Phase
measure: Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥50 c/mL) Through the End of Rescue Phase
timeFrame: 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.
measure: Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥400 c/mL) Through the End of Rescue Phase
timeFrame: Baseline, Week 48 of Rescue Phase
measure: Time to Suppression (Confirmed HIV-1 RNA < 50 c/mL) During Treatment Phase
timeFrame: Week 16-18, Week 24-26, Week 38-40, Week 64-66
measure: Time to Suppression (Confirmed HIV-1 RNA < 400 c/mL) During Treatment Phase
timeFrame: Week 16-18, Week 24-26, Week 30-32
measure: Summary of Adverse Events During Induction Phase
timeFrame: 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).
measure: Summary of Adverse Events During Maintenance Phase
timeFrame: 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.
measure: Summary of Adverse Events During Rescue Phase
timeFrame: 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.
measure: Percent Change From End of Induction Phase in Fasting Lipids at Week 48 of Maintenance Phase
timeFrame: Measurements were included from the end of Induction Phase (Week 26 to Week 30 of Induction therapy) through Week 48 of Maintenance Phase.
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: Local Institution
city: Le Kremlin Bicetre 94
country: France
facility: Local Institution
city: Orleans
country: France
facility: Local Institution
city: Paris Cedex 12
country: France
facility: Local Institution
city: Paris Cedex 20
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Suresnes
country: France
facility: Local Institution
city: Dusseldorf
country: Germany
facility: Local Institution
city: Hannover
country: Germany
facility: Local Institution
city: Stuttgart
country: Germany
facility: Local Institution
city: Ulm
country: Germany
facility: Local Institution
city: Dublin 3
country: Ireland
facility: Local Institution
state: Dublin
city: Dublin 8
country: Ireland
facility: Local Institution
state: Dublin
city: Brescia
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Padova
country: Italy
facility: Local Institution
city: Riga
country: Latvia
facility: Local Institution
city: Cascais
country: Portugal
facility: Local Institution
city: Porto
country: Portugal
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Smolensk
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: Elche
country: Spain
facility: Local Institution
state: Alicante
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Bristol
country: United Kingdom
facility: Local Institution
state: Avon
city: Edinburgh
country: United Kingdom
facility: Local Institution
state: Central
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: