SSAT058: Atripla to Eviplera Switch in Patients Without Central Nervous System Symptoms

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to investigate whether substitution of Efavirenz (EFV) as the Tenofovir/Emtricitabine/Efavirenz (TDF/FTC/EFV) fixed-dose combination (FDC) Atripla, with Rilpivirine as the tenofovir/emtricitabine/rilpivirine (TDF/FTC/RPV) fixed-dose combination (FDC) Eviplera, leads to resolution of covert Central Nervous System (CNS) toxicity associated with EFV, continued virological suppression and immunological reconstitution and whether this is associated with an improvement in quality of life, sleep, anxiety/depression and neurocognitive function; the impact of switch on adherence will also be investigated.

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

Details

• Lead Sponsor: St Stephens Aids Trust
• Collaborator: Gilead Sciences
• Treatments: Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; Rilpivirine; Tenofovir

Criteria

Inclusion Criteria:

Patient volunteers who meet all of the following criteria are eligible for this trial:

1. Is male or female aged 18 years or above

2. Has HIV-1 infection documented in their medical notes

3. Has signed the Informed Consent Form voluntarily

4. Is willing to comply with the protocol requirements

5. Has been on Atripla for at least 12 weeks before enrolment

6. Has an undetectable HIV-plasma viral load at screening by local assay (single re-test allowed)

7. Has a CD4 cell count at screening >50 cells/mm3

8. Has an estimated glomerular filtration rate (MDRD) >50 ml/min.

9. Has no significant CNS symptoms which may be attributable to EFV.

10. If female and of childbearing potential, is using effective birth control methods (for example, hormonal contraceptive, condom, abstinence, IUD, as agreed by the investigator) and is willing to continue practising these birth control methods during the trial and for at least 30 days after the end of the trial. Note: Women who are postmenopausal for least 2 years, women with total hysterectomy, and women who have a tubal ligation are considered of non-childbearing potential

11. If a heterosexually active male, he is using effective birth control methods and is willing to continue practising these birth control methods during the trial and until follow-up visit

Exclusion Criteria:

Patients meeting 1 or more of the following criteria cannot be selected:

1. Infected with HIV-2

2. Using any concomitant therapy disallowed as per SPC for the study drugs (e.g proton pump inhibitors )

3. Has acute viral hepatitis including, but not limited to, A, B, or C

4. Has chronic hepatitis B and/or C with AST and/or ALT >5 x ULN Note: Patients can enter trial with chronic HBV if HBV-DNA undetectable at screen (and no detectable result in last 6 months) and with chronic HCV if not expected to require treatment during the trial period.

5. Any investigational drug within 30 days prior to the trial drug administration

6. Has ever received rilpivirine in the past

7. Any clinical evidence of baseline resistance mutations, prior to commencing antiretroviral therapy.

8. Known allergy to lactose monohydrate, sunset yellow aluminium lake (E110), and patients with galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption

9. Severe hepatic impairment (defined as Child-Pugh-Turcotte (CPT) Score C).

10. If female, she is pregnant or breastfeeding

11. Screening blood result with any grade 3/4 toxicity according to Division of AIDS (DAIDS) grading scale, except: asymptomatic grade 3 glucose, amylase or lipid elevation or asymptomatic grade 4 triglyceride elevation (re-test allowed).

12. Any condition (including drug/alcohol abuse) or laboratory results which, in the investigator's opinion, interfere with assessments or completion of the trial.

13. If participating in the MR Imaging substudy, any contraindications to magnetic resonance scanning according to local radiology guidelines (to be assessed by MR Spectroscopy Imaging Department)