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)

Bristol-Myers Squibb1 site in 1 country252 target enrollmentNovember 2005

ConditionsHIV Infections

InterventionsAtazanavir + 2 NRTIs Atazanavir + Ritonavir + 2 NRTIs

DrugsAtazanavir + 2 NRTIs Atazanavir + Ritonavir + 2 NRTIs

Overview

Phase: Phase 4
Intervention: Atazanavir + 2 NRTIs
Conditions: HIV Infections
Sponsor: Bristol-Myers Squibb
Enrollment: 252
Locations: 1
Primary Endpoint: Percentage of Participants With HIV-1 RNA <50 Copies/mL (c/mL) Through Week 48 of the Maintenance Phase
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2005

End Date

January 2008

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

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/mm
•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,

Arms & Interventions

Switch

ATV 400 mg + 2 NRTIs (TBD), ATV once daily, NRTIs (TBD)

Intervention: Atazanavir + 2 NRTIs

Continuation

ATV 300 mg + RTV 100 mg + 2 NRTIs (TBD), ATV and RTV once daily, NRTIs (TBD)

Intervention: Atazanavir + Ritonavir + 2 NRTIs

Rescue

ATV 300 mg + RTV 100 mg + 2 NRTIs (TBD), ATV and RTV once daily, NRTIs (TBD)

Intervention: Atazanavir + Ritonavir + 2 NRTIs

Outcomes

Primary Outcomes

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

Time Frame: From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase

Participants were considered successes unless they experienced treatment failure, or had missing Week 48 HIV-1 RNA. Treatment failure: virologic rebound (ie, 2 consecutive on-treatment HIV-1 RNA ≥ 50 c/mL, or last HIV-1 RNA ≥ 50 c/mL followed by discontinuation), or discontinuation before Week 48. Denominator included all randomized participants.

Secondary Outcomes

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)
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)
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)
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)
Change From Baseline in CD4 Cell Count at Week 24 of Induction Phase(Baseline, Week 24 of Induction Phase)
Change From Baseline in CD4 Cell Count at Week 48 of Rescue Phase(Baseline, Week 48 of Rescue Phase)
Change From Baseline in HIV-1 RNA at Week 24 of the Induction Phase(Baseline, Week 24 of Induction Phase)
Change From Baseline in HIV-1 RNA at Week 48 of the Rescue Phase(\Baseline, Week 48 of Rescue Phase)
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.)
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)
Time to Suppression (Confirmed HIV-1 RNA < 400 c/mL) During Treatment Phase(Week 16-18, Week 24-26, Week 30-32)
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).)
Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥400 c/mL) Through the End of Rescue Phase(Baseline, Week 48 of Rescue Phase)
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.)
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.)
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.)