Open Label, Pilot Study of Darunavir Boosted by Cobicistat in Combination With Rilpivirine to Treat HIV+ Naïve Subjects

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Current HIV treatment guidelines recommend the use of triple-drug therapy (two nucleoside reverse transcriptase inhibitors and either a protease inhibitor, non-nucleoside reverse transcriptase inhibitor, or an integrase inhibitor) for the treatment of antiretroviral (ARV)-naïve patients. With the introduction of highly active antiretroviral therapy (HAART), patients with HIV are living much longer. With the increasing lifespan of persons with HIV, long-term complications from therapy as well as the occurrence of co-morbidities with aging have prompted HCPs to re-think the current treatment paradigm and consider novel combinations of ARVs. All of the currently approved HIV antiretrovirals have been implicated in causing long-term toxicities; however the greatest body of evidence for long-term metabolic effects has implicated the nucleoside reverse transcriptase (NRTI) class. By utilizing a non-NRTI treatment regimen, it is hypothesized that many of these long-term metabolic effects (renal toxicity, bone loss, body fat changes) can be delayed or avoided altogether. The clinical data on novel combinations is currently limited but rapidly growing and has included several combinations that have utilized darunavir. This study will be the first of its kind using the unique combination of darunavir/cobicistat and rilpivirine. Currently, this drug combination is not a recommended option for first time treatment of HIV

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Therapeutic Concepts
• Collaborator: Janssen Scientific Affairs, LLC
• Treatments: Cobicistat; Darunavir; Rilpivirine

Criteria

Inclusion Criteria:

1. HIV-1 RNA ≥ 5000 copies/mL by PCR

2. ≥ 18 years of age

3. Cognitive ability to understand and provide written informed consent and willingness to participate in and comply with the study protocol

4. Less than 7 days of prior ART with any licensed or investigational compound

5. Patient does not currently have or has not been treated for an active opportunistic infection (OI) consistent with CDC definition (Appendix C) within 30 days of screening

6. Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness

7. A female is eligible to enter and participate in this study if she is of non child bearing potential or child bearing potential, has a negative serum pregnancy test at screen.

Exclusion Criteria

1. Patient with active AIDS-defining opportunistic infection or disease according to the 1993 CDC AIDS surveillance definition (Clinical Category C) in the 30 days prior to baseline and that, in the opinion of the investigator, would preclude the patient from participating in the study (See Appendix C).

2. Patient has none of the following darunavir-associated RAMs: V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V

3. Having documented genotypic evidence of NNRTI resistance at screening or from historical data available in the source documents, i.e. at least one of the NNRTI rams from the following list; K101E, K101P, E138A, E138G, E138K, E138R, E138Q, , V179L, Y181C, Y181I, Y181V, Y188L, H221Y, F227C, M230I, M230L, or the combination of the K103N and L100I.

4. History of active substance abuse, excluding cannabis, or psychiatric illness that, in the opinion of the investigator, would preclude compliance with protocol, dosing schedule and assessments.

5. Patient is either pregnant at time of screening evaluation or breast-feeding.

6. Patient, in the opinion of the investigator, is unlikely to be able to complete the 48-week dosing period and protocol evaluations and assessments or adhere to the study drug regimen.

7. Patient suffers from a serious medical condition, such as diabetes, congestive heart failure, cardiomyopathy or other cardiac dysfunction, which in the opinion of the investigator would compromise the safety of the patient

8. Patient has malabsorption syndrome or other gastrointestinal dysfunction, which may interfere with drug absorption or render the patient unable to take oral medication.

9. Patient is undergoing interferon therapy for HCV or anticipates undergoing therapy during the course of this trial

10. HBV co-infection

11. Patient has any of the following laboratory results within 30 days prior to the first dose of study medication:

• Hemoglobin concentration < 8.0 g/dL

• Absolute neutrophil count < 750 cells/mm3

• Platelet count <50,000 cells/ mm3

• Aminotransferase (AST, ALT) >3 times ULN

• Serum creatinine >1.5 times the Upper Limits of Normal (ULN)

12. Patients with severe hepatic impairment

13. Patient has required treatment with radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to entry, or has an anticipated need for these agents within the study period.