Roll-Over Protocol To Provide Atv And/Or Truvada For Extended Access
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| ClinicalTrials.gov Identifier: NCT01003990 |
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Recruitment Status :
Completed
First Posted : October 29, 2009
Results First Posted : May 11, 2017
Last Update Posted : May 11, 2017
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV | Drug: Atazanavir Drug: Atazanavir/Ritonavir Drug: Tenofovir/Emtricitabine Drug: Lopinavir/ritonavir | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 710 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Atazanavir (BMS-232632) for HIV Infected Individuals Completing Atazanavir Clinical Trials: An Extended Access Study |
| Study Start Date : | October 2002 |
| Actual Primary Completion Date : | February 2016 |
| Actual Study Completion Date : | February 2016 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Atazanavir |
Drug: Atazanavir
Tablets, Oral, 400 mg, once daily, indefinitely
Other Names:
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| Experimental: Atazanavir/Ritonavir |
Drug: Atazanavir/Ritonavir
Tablets, Oral, 300/100 mg, once daily, indefinitely
Other Names:
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Active Comparator: Lopinavir/Ritonavir
Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).
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Drug: Tenofovir/Emtricitabine
Tablets, Oral, 300/200 mg, once daily, indefinitely
Other Name: Truvada Drug: Lopinavir/ritonavir Tablets, Oral, 400/100 mg, twice daily, indefinitely |
Primary Outcome Measures :
- Number of Participants With Serious Adverse Events (SAEs), Treatment Related SAEs, Treatment Related Adverse Events (AEs), AEs Leading to Discontinuation of Study Therapy, Grade 3 to Grade 4 AEs, Grade 3 to Grade 4 AEs, CDC Class C AIDS Events, or Death [ Time Frame: Date of First Dose to 30 days post the last dose; approximately 405 weeks) ]AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. AIDS Defining Diagnosis ( CDC Class C AIDS Events) are identified from HIV Related Diagnosis.
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects must provide written informed consent
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01003990
Locations
Show 89 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01003990 |
| Other Study ID Numbers: |
AI424-077 |
| First Posted: | October 29, 2009 Key Record Dates |
| Results First Posted: | May 11, 2017 |
| Last Update Posted: | May 11, 2017 |
| Last Verified: | April 2017 |
Keywords provided by Bristol-Myers Squibb:
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Treatment experienced |
Additional relevant MeSH terms:
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Ritonavir Lopinavir Atazanavir Sulfate Tenofovir Emtricitabine HIV Protease Inhibitors Viral Protease Inhibitors Protease Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |