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About
The purpose of this study is to compare the safety and efficacy of a combination of a QD regimen consisting on ritonavir boosted darunavir (FDC) and lamivudine versus ritonavir boosted darunavir (FDC) plus co-formulated tenofovir and emtricitabine or co-formulated tenofovir/lamivudine in naïve HIV-1 infected patients. Subjects will be ARV-naïve HIV-1-infected patients eligible to start ARV therapy according to current guidelines.Subjects will be adults ≥ 18 years of age who meet all of the inclusion criteria and none of the exclusion criteria.
Full description
Key Inclusion Criteria
Key Exclusion Criteria
Primary Objective
• Proportion of patients with HIV-1 RNA levels of less than 50 copies/mL at week 48 (ITT analysis, Snapshot analysis)
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion criteria :
> 18 years of age.
Patient with documented HIV-1 infection defined as a positive ELISA plus a confirmatory Western Blot; or alternatively, a plasma HIV-1 RNA ≥1,000 copies/mL ever documented.
Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB) / Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed.
Subject agrees not to take any medication during the study, including over the counter medicines or herbal preparations, without the approval of the trial physician.
Documented HIV-1 RNA >1,000 copies/mL
Subject naïve to ARV. (Patients who had received ARV ≤ 48 hours are allowed). Subject has indication to receive an antiretroviral regimen.
Subjects can comply with protocol requirements.
Subject's general medical condition, in the investigator's opinion, does not interfere with assessments and completion of the trial.
If patient is a female she must not be breastfeeding or pregnant. She must be either postmenopausal for at least one year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or she must:
For male patients, must comply with the use of a barrier birth control method during the Study and 60 days beyond the Study completion
Exclusion criteria :
Evidence of resistance to or 3TC or DRV/r, TDF, FTC o 3TC based in the results of the resistance testing done in the screening visit, such resistance being considered in accordance with IAS-USA panel, version dated March 2013.
Any of the following mutations will be considered resistance to DRV/r :
Prior HIV-2 documented infection.
The use of disallowed concomitant therapy (see Appendix C).
Active Hepatitis B infection (at any stage).
The patient was diagnosed with acute active hepatitis by any cause, or chronic hepatitis C WITH levels of aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 5 higher than the upper limit of normal (ULN) AND/OR may require one-year treatment.
Any clinical significant active disease (for instance, tuberculosis, heart failure, pancreatitis) or any medical history or physical examination findings that, according to the investigator's opinion, may risk the patient's safety, the results of the study or adherence to the rules of the protocol.
The patient has an active AIDS-associated opportunistic disease (Category C according to the CDC classification system for HIV infection as of 1993) within 30 days after the screening. Stabilized patients under treatment for AIDS-associated opportunistic disease may be included in the study.
Life expectancy < 1 year according to the investigator
Laboratory tests performed during the screening visit show any of the following alterations:
The use of any study agent within 30 days as from the screening.
Use of immunosuppressive drugs, cytokines inhibitors or other cytokines over the prior year.
Any other condition (including, without limitation, the use of alcohol or drugs) that in the investigator's opinion may compromise the safety of the patient or his/her adherence to the protocol
Patients who are pregnant or breastfeeding
Primary purpose
Allocation
Interventional model
Masking
145 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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