BMS-Reyataz Study in Treatment in Naive Subjects to Compare the Efficacy and Safety Between Boosted Reyataz and Kaletra When in Combination With Fixed Dose Truvada

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: HIV Infections

Treatments: Drug: RTV; Drug: LPV; Drug: Tenofovi-Emtricitabine (TDF/FTC) tablet; Drug: ATV

Study type: Interventional

Funder types: Industry

Identifiers

NCT00272779

AI424-138

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability and antiviral effects of atazanavir (ATV) plus ritonavir (RTV) versus a combination drug of lopinavir (LPV) plus RTV. A combination drug containing tenofovir (TDF) and emtricitabine (FTC) will also be taken by participants in both arms.

Enrollment: 1,057 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV RNA ≥5000 c/ml

Exclusion criteria

• Any antiretroviral therapy within 30 days prior to screening;

• Women of Childbearing potential (WOCBP) unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 8 weeks after the study;

• WOCBP using a prohibited contraceptive method

• WOCBP 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;

• Suspected primary (acute) HIV infection;

• Prior antiviral therapy (>30 days of NRTI and/or >7 days of non-nucleoside reverse transcriptase inhibitor (NNRTI) or PI therapies) or any antiretroviral therapy within 30 days prior to screening; some exceptions are allowed for ARV therapy in use for Mother-to-child transmission;

• Participants with Cushing's syndrome;

• Untreated hypothyroidism or hyperthyroidism. A participant who is euthyroid on a stable replacement dose of thyroid hormone is acceptable provided the thyroid stimulating hormone (TSH) performed within 30 days of screening is within normal drug range;

• Recent therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start or expected need for such therapy at the time of enrollment; or therapy with methadone or ribavirin/interferons or treatment with neurotoxic drugs or drugs that affect CYP3A4;

• Participants with obstructive liver disease;

• 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;

• Proven or suspected acute hepatitis in the 30 days prior to study entry;

• Intractable diarrhea (≥6 loose stools/day for at least 7 consecutive days) within 30 days prior to study entry;

• Inability to swallow capsules;

• Active peripheral neuropathy;

• Presence of cardiomyopathy (due to any cause) or any significant cardiovascular disease, such as unstable ischemic heart disease;

• Known, clinically significant cardiac conduction system disease.

• Baseline laboratory values measured within 2 weeks prior to initiating study drugs as follows:

  1. calculated creatine clearance <60 mL/min as estimated by the Cockcroft-Gault equation;
  2. total serum lipase ≥ 1.4 times the upper limit of normal;
  3. liver enzymes (AST, ALT) ≥ 5 times the upper limit of normal;
  4. total serum bilirubin ≥ 1.5 times the upper limit of normal.

• Hypersensitivity to any component of the formulation of study drug;

• Prohibited therapies;

• Any other clinical conditions or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for study or unable to comply with the dosing requirements;

• Prisoners or participants who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,057 participants in 2 patient groups

Atazanavir (ATV) + Ritonovir (RTV)

Active Comparator group

Description:

Participants were administered an oral dose of ATV 300 mg and RTV 100 mg once daily along with food on a background of fixed dose combination TDF 300 mg plus FTC 200 mg (TDF/FTC) once daily. Doses of ATV and RTV were taken 24 hours apart at the same time as the background TDF/FTC, up to 96 Weeks.

Treatment:

Drug: Tenofovi-Emtricitabine (TDF/FTC) tablet

Drug: ATV

Drug: RTV

Lopinavir (LPV) + RTV

Active Comparator group

Description:

Participants were administered an oral dose of LPV 400 mg and RTV 100 mg once daily along with food on a background of fixed dose combination TDF 300 mg plus FTC 200 mg (TDF/FTC) once daily. Doses of LPV and RTV were taken 24 hours apart at the same time as the background TDF/FTC, up to 96 Weeks.

Treatment:

Drug: LPV

Drug: Tenofovi-Emtricitabine (TDF/FTC) tablet

Drug: RTV