Status:
COMPLETED
Dose Escalation Study to Determine the Pharmacokinetics of Atazanavir Administered With RIfampicin to HIV Positive Adults on sEcond-line ART Regimen With Suppressed HIV-1 Viral Load
Lead Sponsor:
University of Liverpool
Collaborating Sponsors:
European and Developing Countries Clinical Trials Partnership (Funder)
Joint Clinical Research Centre, Kampala, Uganda
Conditions:
HIV/AIDS
Tuberculosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The standard treatment for TB consists of rifampicin (RIF) as part of the regimen. However, due to drug-drug interactions (DDI), the bioavailability of PIs is greatly reduced when co-administered with...
Detailed Description
Background and Justification Both HIV and TB can successfully be managed using the currently available medications with the latter being curable. However, due to the detrimental drug-drug interaction...
Eligibility Criteria
Inclusion
- Willing and able to provide a signed and dated informed consent
- HIV positive male or female ≥ 18 years of age
- 50 - 75kg of weight
- On ATV/rand 2 nucleos(t)ide reverse transcriptase inhibitor containing ART regimen for at least 6 months
- 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.
- A negative pregnancy test for females of child-bearing potential. Should also not be breast feeding.
- 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).
- Clinically stable with no AIDS defining illness within the past 6 months.
- A normal chest x-ray
- Ability and willingness to understand and adhere to the study procedures for the entire study duration.
- Able to attend for regular study follow-up visits
Exclusion
- Any clinical contraindications to the use of ATV/r, DTG or RIF.
- Currently receiving treatment for tuberculosis
- Hepatitis B surface antigen positive or Hepatitis C Antibody positive.
- Requirement for concomitant medication with known major interactions with study drugs
- Current participation in another clinical trial or research protocol
- Symptoms of TB
- weight loss \> 2.5% in 4 weeks;
- cough \> 2 weeks;
- night sweats\> 2 weeks;
- fever \> 2 weeks;
- 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.
- Moderate to severe anaemia (Haemoglobin level \< 8 g/dL)
- 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.
- 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.
- Known chronic underlying disease such as sickle cell disease, diabetes and severe cardiac impairment.
- Inability to tolerate oral medication, or to drink.
- Patients taking drugs that are strong inducers of CYP3A4 such as carbamazepine and phenytoin.
- Known hypersensitivity to any of the agents used in the study
- Patients with prior herbal medication within one week of screening
- Use of other investigational drugs within 30 days of enrolment
- Patients taking medications prohibited by the protocol (see appendix 5)
- 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.
Key Trial Info
Start Date :
October 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04121195
Start Date
October 30 2020
End Date
May 20 2023
Last Update
July 12 2024
Active Locations (1)
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1
Joint Clinical Research Centre
Kampala, Uganda, PO Box 10005