Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT03696160
Eligibility Criteria:
Inclusion Criteria:
1. The ability to understand and sign a written informed consent form (ICF) and must be willing to comply with all study requirements.
2. Male or non-pregnant, non-lactating females†.
3. Age ≥ 18 years.
4. Have documented, untreated HIV-1 infection with either:
1. AIDS with any CD4 cell count (AIDS-defining conditions are listed within Appendix 3).
Or
2. Severe bacterial infection (BI)‡ and must have a CD4 cell count \< 200/μl within 28 days prior to study entry§.
Or
3. Any symptoms or no symptoms and must have a CD4 cell count \< 100/μL within 28 days prior to study entry and must have an entry HIV viral load \> 1000 copies/mL.
Or
4. Currently receiving treatment for OI\*\*. i. Subjects with other serious OIs, including other AIDS-defining and AIDS-related OIs for which appropriate therapy other than ART exists are eligible, but Investigator approval must be obtained. ii. Current OI treatment can have been discontinued prior to start of ART.
5. Have an entry HIV viral load \> 1000 copies/mL
6. Have the ability to take oral medications.
7. Females of childbearing potential and heterosexually active males must be willing to use a highly effective method of contraception and be willing to continue practising these birth control methods during the trial and for at least 30 days after the last dose of study medication. See Appendix 7 for further details.
Such methods include:
* True abstinence from penile-vaginal intercourse, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), and withdrawal are not acceptable methods of contraception).
* Non-hormonal Intrauterine device or non-hormonal intrauterine system that meets the effectiveness criteria as stated in the product label.
* Male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject.
* Combined (oestrogen and progesterone containing) hormonal contraception associated with the inhibition of ovulation\*:
* Oral
* Intravaginal
* Transdermal
* Bilateral tubal occlusion
Exclusion Criteria:
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 (see Summary of Product Characteristics (SmPC) for Symtuza® and Biktarvy®) 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 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03696160
Study Brief:
Protocol Section:
NCT03696160