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:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-24 @ 2:11 PM
NCT ID:
NCT04121195
Eligibility Criteria:
Inclusion Criteria:
1. Willing and able to provide a signed and dated informed consent
2. HIV positive male or female ≥ 18 years of age
3. 50 - 75kg of weight
4. On ATV/rand 2 nucleos(t)ide reverse transcriptase inhibitor containing ART regimen for at least 6 months
5. Undetectable HIV viral load (\<50 copies/ml) at screening PLUS an undetectable VL during the most recent test done between 6 and 12 months prior to screening.
6. A negative pregnancy test for females of child-bearing potential. Should also not be breast feeding.
7. On or willing to use effective contraception for at least 4 weeks prior to enrolment, throughout the study period and at least 4 weeks after end of the study(please see section 10.3 for a detailed definition of effective contraception for this study).
8. Clinically stable with no AIDS defining illness within the past 6 months.
9. A normal chest x-ray
10. Ability and willingness to understand and adhere to the study procedures for the entire study duration.
11. Able to attend for regular study follow-up visits
Exclusion Criteria:
1. Any clinical contraindications to the use of ATV/r, DTG or RIF.
2. Currently receiving treatment for tuberculosis
3. Hepatitis B surface antigen positive or Hepatitis C Antibody positive.
4. Requirement for concomitant medication with known major interactions with study drugs
5. Current participation in another clinical trial or research protocol
6. Symptoms of TB
* weight loss \> 2.5% in 4 weeks;
* cough \> 2 weeks;
* night sweats\> 2 weeks;
* fever \> 2 weeks;
7. Clinical or laboratory evidence of any of the following:
* AST/ALT \> 1.5 x the upper limit of normal range (ULN)
* AST/ALT \> 1.0 x ULN
* \> 125 mg/dl fasting serum glucose;
* Serum creatinine ≥ 1.5 X ULN in the absence of dehydration. Or estimated glomerular filtration rate \<60mL/min according to Cockcroft-Gault formula for creatinine clearance.
8. Moderate to severe anaemia (Haemoglobin level \< 8 g/dL)
9. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study. The investigator should make this determination in consideration of the patient's medical history, clinical and/or laboratory results.
10. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
11. Known chronic underlying disease such as sickle cell disease, diabetes and severe cardiac impairment.
12. Inability to tolerate oral medication, or to drink.
13. Patients taking drugs that are strong inducers of CYP3A4 such as carbamazepine and phenytoin.
14. Known hypersensitivity to any of the agents used in the study
15. Patients with prior herbal medication within one week of screening
16. Use of other investigational drugs within 30 days of enrolment
17. Patients taking medications prohibited by the protocol (see appendix 5)
18. History of substantial use of alcohol that interferes with expected normal activities as determined by the investigator. Additionally, alcohol should be avoided throughout the study period.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04121195
Study Brief:
Protocol Section:
NCT04121195