Study to Investigate two therapy against HIV virus for Patients with Advanced Disease.
- Conditions
- Patients who present late on during their acquisition of the HIV-1 (Human Immunodeficiency Virus)Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2018-003481-13-IT
- Lead Sponsor
- EAT ID Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 440
1. Ability to understand and sign a written informed consent form (ICF) and must
be willing to comply with all study requirements
2. = 18 years
3. HIV-1 infected AIDS except active tuberculosis (TB) or cryptococcal meningitis with any CD4 cell count, or; severe bacterial infection (BI) and must have a CD4 cell count < 200/µL within 28 days prior to study entry, or; any symptoms or no symptoms with CD4 cell count < 100/µL within 28 days prior to study entry and must have an entry HIV viral load > 1000 copies/mL, or; currently being treated for opportunistic infections (OI)
4. Have an entry HIV viral load > 1000 copies/mL
5. Able to take oral medications
6. ART-naïve prior to study enrolment
7. Willing to use acceptable methods of contraception
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 88
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
1. Any therapeutic ARV which commenced less than 2 weeks prior to screening and which was taken for more than 48 hours
2. Systemic cancer chemotherapy within 30 days prior to study entry, or current treatment for cancer (with the exception of Kaposi’s sarcoma) or lymphoma.
3. Current or anticipated use of contraindicated medications or anticipated systemic chemotherapy during study enrolment (administration of any contraindicated medication must be discontinued at least 30 days prior to the baseline visit and for the duration of the study).
4. Known resistance to the components of study medications (see section 6.1.3 for more details).
5. History or symptoms of advanced renal and/or hepatic impairment. Such as, kidney failure requiring dialysis; eGFR <30 mL/min; hepatic transaminases (AST and ALT) > 5 x upper limit of normal (ULN); or, platelet count <50,000.
6. Current drug or alcohol use that, in the opinion of the Investigator, would cause interference with the study.
7. Cryptococcal meningitis or active TB or current or expected treatment requiring Rifampicin or Rifabutin (patients with expected latent TB will have a TB test (IGRAs e.g. ELISPOT, QuantiFERON etc.) at their screening visit).
8. History or presence of allergy to the study drugs or their components, or drugs of their class.
9. Using any concomitant therapy disallowed as per the reference safety information (RSI) and product labelling for the study drugs.
10. Any investigational drug within 30 days prior to the study drug administration.
11. Patients with severe (Child Pugh class C) hepatic impairment.
12. Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study.
13. Females of childbearing potential and heterosexually active males must be willing to use a highly effective method of contraception.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method