EUCTR2012-002663-10-GB
Active, not recruiting
Phase 1
A phase IV, open-label single-arm study investigating the pharmacokinetics and pharmacodynamics of the antiretroviral combination of rilpivirine and ritonavir-boosted darunavir in therapy-naive HIV-1 infected patients. - Darunavir/ritonavir and rilpivirine in therapy-naïve patients
St Stephen's AIDS Trust0 sites36 target enrollmentOctober 8, 2012
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- HIV-1
- Sponsor
- St Stephen's AIDS Trust
- Enrollment
- 36
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Patient has signed and dated informed consent document, confirming their knowledge of the pertinent aspects of the study and willingness to comply with all study requirements, prior to screening procedures.
- •\- Male or female aged 18 to 65 years.
- •\- HIV\-1 infected with less than and including 14 days total exposure to antiretroviral therapy – prior antiretrovirals as post\-exposure prophylaxis permissible if documented negative test at 3 months following exposure. If patient has previously taken up to and including 14 days antiretroviral therapy during HIV\-1 infection, this must not be within 12 weeks of the screening visit and there must be an available genotypic resistance test after last intake which indicates full viral susceptibility to study medication.
- •\- CD4 count \>50 cells/mm3 at screening.
- •\- HIV\-1 RNA \> 1000 copies/mL at screening.
- •\- Women of childbearing potential (WoCBP); negative urine ß\-hCG pregnancy test at screen and baseline visit.
- •\- WOCBP, male patients and their partners must use two forms of contraception, one of which is an effective barrier method, when participating in sexual activity which could result in conception throughout the study and for 28 days following the last dose of study medication.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •\- Infected with HIV\-2
- •\- Any medical, psychiatric or substance misuse disorders felt by the investigator to impact on the subject’s ability to participate in the study, including a positive urine test for drugs of abuse (cannabinoids are not exclusionary).
- •\- Disallowed concomitant medication as per the summary of product characteristics for darunavir or rilpivirine
- •\- Any genotypic resistance mutations on screening or prior tests to darunavir (V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V) or rilpivirine (K101E, K101P, E138A, E138G, E138K, E138R, E138Q, V179L, Y181C, Y181I, Y181V, H221Y, F227C, M230I, and M230L).
- •\- Screening ALT or AST elevation greater than 5 times the upper limit of normal.
- •\- Any active opportunistic infection within 4 weeks prior to planned baseline visit.
- •\- Any active cardiovascular, pulmonary, hepatic, renal or metabolic disease, or therapy used to treat these diseases, which in the opinion of the investigator could affect the absorption, distribution, metabolism or efficacy of the study medication.
- •\- Any known or suspected allergic reaction to the investigational products or excipients (including E110 allergy with regard to darunavir tablets).
- •\- Hepatitis B or C co\-infection (defined as positive hepatitis B surface antigen or positive hepatitis C antibody; patients with positive hepatitis C antibody with undetectable RNA will be eligible for inclusion).
- •\- Estimated GFR (MDRD method) less than 50 ml/min
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
An open-label, single-arm, phase IV study assessing the immunogenicity and safety of ZOSTAVAX? at minimum release specification approaching expiry potency in subjects =50 years oldot applicable_Healthy volunteers_Up to 50 years of ageEUCTR2007-006532-66-FRSanofi Pasteur MSD SNC
Completed
Phase 4
A Phase 4, Open-label, Single Arm Study to Evaluate the Safety and Tolerability of a Three-day Fosaprepitant Regimen Administered for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Participants Receiving Emetogenic ChemotherapySymptomen en algemene pathologieChemotherapy-Induced Nausea and VomitingNL-OMON48224Merck Sharp & Dohme (MSD)6
Active, not recruiting
Phase 1
Three-day Fosaprepitant Regimen CINV Safety Study in Pediatric ParticipantsPrevention of Chemotherapy-Induced Nausea and Vomiting (CINV)MedDRA version: 21.1Level: PTClassification code 10054133Term: Prophylaxis of nausea and vomitingSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Symptoms and general pathology [C23]EUCTR2018-004844-43-GRMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.100
Active, not recruiting
Phase 1
Three-day Fosaprepitant Regimen CINV Safety Study in Pediatric ParticipantsPrevention of Chemotherapy-Induced Nausea and Vomiting (CINV)MedDRA version: 20.1Level: PTClassification code 10054133Term: Prophylaxis of nausea and vomitingSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Symptoms and general pathology [C23]EUCTR2018-004844-43-NLMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.100
Active, not recruiting
Phase 1
Three-day Fosaprepitant Regimen CINV Safety Study in Pediatric ParticipantsEUCTR2018-004844-43-PLMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.100