Roll-Over Protocol To Provide Atv And/Or Truvada For Extended Access

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: HIV

Treatments: Drug: Atazanavir/Ritonavir; Drug: Tenofovir/Emtricitabine; Drug: Lopinavir/ritonavir; Drug: Atazanavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01003990

AI424-077

Details and patient eligibility

About

The purpose of this study is to provide atazanavir or tenofovir-emtricitabine to HIV-infected subjects who have completed atazanavir or tenofovir-emtricitabine therapy on a previous BMS sponsored clinical trial and to collect long-term safety information on the treated population.

Full description

Provide study drug for patients rolling off BMS ATV clinical trials in countries where these medications are not commercially available.

Enrollment: 710 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must provide written informed consent

• Currently receiving atazanavir (unboosted or boosted with 100 mg ritonavir QD)and/or tenofovir-emtricitabine at time of screening and viral load is

  ≤ 10,000 copies/mL while on therapy

• Subjects who are receiving investigational antiretroviral agents through Expanded Access Programs will be allowed to participate following discussion and approval by the BMS Medical Monitor

• ≥ 16 years of age (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 to reduce transmission of sexually transmitted diseases, including HIV. Other contraception in addition to barrier methods are permitted, however interactions between atazanavir and oral contraceptives have not been studied

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 (no contraceptive methods prohibited in this study. However, caution is warranted with coadministration of oral contraceptives)
• Women who are pregnant or breastfeeding
• Women with a positive pregnancy test on enrollment or prior to study drug administration, with the exception of women rolling over from AI424182, who may still have a positive β-HCG test at the time of enrollment
• All subjects previously discontinued from an atazanavir study for any reason
• Active alcohol or substance abuse sufficient, in the Investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis
• Any other clinical conditions or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for study, or unable to comply with the dosing requirements
• Any of the following laboratory values:
• a) Serum creatinine ≥ 1.5 times the upper limit of normal,
• b) Liver enzymes (AST, ALT) ≥ 5 times the upper limit of normal,
• Hypersensitivity to any component of the formulation of study drug
• Refer to Section 6.4.1 which details all prohibited therapies
• Prisoners or subjects 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: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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710 participants in 3 patient groups

Atazanavir

Experimental group

Treatment:

Drug: Atazanavir

Atazanavir/Ritonavir

Experimental group

Treatment:

Drug: Atazanavir/Ritonavir

Lopinavir/Ritonavir

Active Comparator group

Description:

Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).

Treatment:

Drug: Lopinavir/ritonavir

Drug: Tenofovir/Emtricitabine