HIV Viremia and Persistence in Acutely HIV-Infected Patients Treated With Darunavir/Ritonavir and Etravirine

• Status: Terminated
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Purpose: This is a pilot study to evaluate HIV viremia and persistence in acutely HIV infected antiretroviral naïve patients treated with Darunavir/ritonavir and Etravirine

Participants: 20 participants, age 18 and older, HIV infected, antiretroviral naïve patients

Procedures (methods): ARV treatment with Darunavir/ritonavir and Etravirine,

Optional studies:

Genital secretion samples, Cerebrospinal fluid samples, Leukapheresis, Endoscopy/colonoscopy

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

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: Janssen Pharmaceuticals
• Treatments: Darunavir; Etravirine; Ritonavir

Criteria

Inclusion Criteria:

1. Documentation of Acute HIV Infection as defined above.

2. Men and women age ≥18 years.

3. Participants will be ART naïve, defined as ≤14 days of antiretroviral treatment at any time prior to entry. The only exceptions are: Post-exposure prophylaxis (PEP) provided the patient was documented as HIV-1 negative at least 3-6 months after completion of the PEP treatment.

4. Screening HIV-1 RNA >1,000 copies/mL obtained within 30 days at study entry.

5. Lab values obtained within 30 days prior to study entry:

6. Absolute neutrophil count >500/mm3

7. Hemoglobin > 8.5 g/dL for men and > 8.0 g/dL for women

8. Platelet count >50,000/mm3

9. AST (SGOT) ≤2.5 x ULN

10. ALT (SGPT) ≤2.5 x ULN

11. Total bilirubin <2.5 x ULN

12. Calculated creatinine clearance (Cockcroft-Gault formula) > 30mL/min:

• CrCl = (140-age) x body weight (kg) (x 0.85 if female)

• Serum creatinine [mg/dL] x (72)

13. For women of reproductive potential, a negative serum or urine pregnancy test within 7 days prior to initiating antiretroviral study medications. Reproductive potential is defined as females who have reached menarche and have not been post-menopausal for at least 24 consecutive months, or have not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, or salpingotomy). Acceptable documentation of surgical sterilization includes patient-reported history.

14. If participating in sexual activity that could lead to pregnancy, female study patients must use at least one form of contraception, which could consist only of a barrier method. All patients must continue to use contraception for 6 weeks after stopping the study medications. Acceptable methods of contraception include: condoms (male or female) with or without spermicidal agent, diaphragm or cervical cap with spermicide, or IUD. Female volunteers not of reproductive potential are not required to use contraception.

15. Ability and willingness of patient to give written informed consent.

Exclusion Criteria:

1. Women who are pregnant or breast-feeding.

2. Women with a positive pregnancy test on enrollment or prior to study drug administration.

3. Women of reproductive potential who are unwilling or unable to use acceptable methods to avoid pregnancy for the entire study period

4. Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry.

• Prednisone at a daily dose of 10 mg or less (physiologic replacement dose) is permitted.

5. Known allergy/sensitivity to study drugs or their formulations.

6. Difficulty swallowing capsules/tablets.

7. Inability to communicate effectively with study personnel.

8. Incarceration; prisoner recruitment and participation are not permitted.

9. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements or confound the analysis of study endpoints.

10. Any active psychiatric illness including schizophrenia, severe depression, or severe bipolar affective disorder that, in the opinion of the investigator, could confound the analysis of the neurological examination or neuropsychological test results.

11. Active brain infection (except for HIV-1), brain neoplasm, space-occupying brain lesion requiring acute or chronic therapy. Participants with any fungal meningitis, parasitic infection, or CNS lymphoma are excluded from participation.

12. Serious illness requiring systemic treatment and/or hospitalization until patient either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to study entry. NOTE: Oral candidiasis, vaginal candidiasis, mucocutaneous herpes simplex, and other minor illnesses (as judged by the site investigator) have no restriction.

13. Known cardiac conduction disease.

14. Prior treatment with any other experimental drug for any indication (within 30 days of initiating study treatment).

15. Unable to discontinue any current medications that are excluded during study treatment.

16. A life expectancy less than twelve months.

17. Acute Viral Hepatitis, including, but not limited to, Hepatitis A, B, or C

18. Chronic Hepatitis B Infection documented by a detectable serum Hepatitis B surface antigen (HBsAg) or plasma HBV DNA