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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: Atazanavir + 2 NRTIs; Drug: Atazanavir + Ritonavir + 2 NRTIs

Study type: Interventional

Funder types: Industry

Identifiers

NCT00207142

AI424-136

Details and patient eligibility

About

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.

Enrollment: 252 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

252 participants in 3 patient groups

Switch

Active Comparator group

Description:

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

Treatment:

Drug: Atazanavir + 2 NRTIs

Continuation

Active Comparator group

Description:

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

Treatment:

Drug: Atazanavir + Ritonavir + 2 NRTIs

Rescue

Other group

Description:

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

Treatment:

Drug: Atazanavir + Ritonavir + 2 NRTIs