Clinical Trial to Evaluate Drug-drug Interactions Between Darunavir/Cobicistat and Etravirine in Hiv- Infected Patients

• Status: Completed
• Trial end date: 2016-11-23
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to provide information about the safety and pharmacokinetic drug-drug interactions between darunavir/cobicistat (800/150mg QD) and etravirine (400mg QD) in HIV-infected patients, as well as evaluate the efficacy of concomitant administration of darunavir/cobicistat and etravirine.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacio Lluita Contra la SIDA; Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
• Treatments: Cobicistat; Darunavir; Etravirine

Criteria

Inclusion Criteria:

1. Age ≥18 years old

2. Documented HIV infection (western blot)

3. Stable antiretroviral treatment including darunavir/cobicistat 800/150mg QD (cohort DRV) or etravirine 400mg QD (cohort ETR) for at least 4 weeks. Plasma HIV-1 RNA load <50 copies/mL for at least 12 weeks

4. In women of childbearing age*, commitment to use at least one of these birth control methods: male or female condom with or without spermicide, cap, diaphragm or sponge with or without spermicide, intrauterine device, bilateral tubal occlusion, vasectomised partner, sexual abstinence during the study.

5. Signed Informed Consent

• According to recommendations of Clinical Trial Facilitation Group (CTFG), a woman is considered of childbearing potential: fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.

Exclusion Criteria:

1. Inadequate adherence to antiretroviral treatment (<90% during the last week)

2. Patients who are taking or have been taking any other medication within the last two weeks prior to be recruited in the study, including herbal medicines and food supplements, with known interactions with darunavir, cobicistat or etravirine (i.e St. John's wort, grapefruit juice, some antibiotics such as erythromycin or rifampicin; antiepileptics such as phenytoin, phenobarbital or carbamazepine; antifungals such as itraconazole or ketoconazole; antiretrovirals such as ritonavir, efavirenz or nevirapine, among others.)

3. Acute illness that could interfere with darunavir, cobicistat or etravirine pharmacokinetics (acute hepatitis…) within the prior 4 weeks

4. Active AIDS-defining illness within the prior 4 weeks

5. In women, pregnancy or breastfeeding.

6. Evidence or clinical suspicion that the patient will not be able to complete the study treatment and protocol