Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Makerere University
With
Infectious Diseases Institute, Uganda
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Male or female, age 12 years and above
2. Body weight at least 40kg
3. Taking a tenofovir plus lamivudine/emtricitabine plus NNRTI-based regimen continuously for a total period of at least 6 months
4. Good adherence to ART, defined as missing medication on no more than 3 days in the one month prior to screening. \[Patients who do not have good adherence should be given adherence counselling and re-assessed after an interval of not less than 4 weeks\].
5. HIV treatment failure defined by virological criteria (modified from WHO 2016 criteria); Viral load ≥ 1000 copies/ml at screening AND EITHER Viral load ≥ 1000 copies/ml on the previous test, taken after at least 6 months on ART, and at no more than 6 months prior to screening and at no less than 4 weeks prior to screening, with adherence counselling given after the previous test OR Viral load ≥ 1000 copies/ml on a confirmatory test taken no less than 4 weeks after screening with adherence counselling given after the screening test
6. If a woman of childbearing potential, must be willing to use effective contraception. \[Childbearing potential is defined as being not premenarchal; not post-menopausal (\> 12 months of spontaneous amenorrhea and ≥45 years of age); and not permanently sterilised\].
7. Willing and able to provide written informed consent
8. Able to attend regular study follow-up visits
You may not be if
1. Prior use of protease inhibitor or integrase inhibitor therapy
2. Requirement for concomitant medication with known major interactions with study drugs for which drug substitutions or dose alterations are not available or acceptable (if the patient requires rifamycin-based TB treatment, rifabutin must be available at the site).
3. Women who are currently pregnant or breastfeeding.
4. Severe hepatic impairment (with ascites and/or encephalopathy)
5. ALT \> 5 times upper limit of normal
6. Estimated glomerular filtration rate (eGFR) \< 50 ml/min/1.73m2 at screening calculated using the CKD-EPI equation
7. Current participation in another clinical trial or research protocol (may be permitted in some circumstances; but must first be discussed with the NADIA Chief Investigator)
8. Life expectancy of less than one month in the opinion of the treating physician
