HIV/AIDS
Conditions
Interventions
TafED
AZT 3TC plus LPV ritonavir
AZT 3TC plus Atazanavir and Ritonavir
Sponsors
Mylan Laboratories Limited
The Global Fund
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants will eligible for study participation if they meet the following criteria: 1. HIV-1 infection, as documented by confirmed licensed rapid test kit at any time prior to study entry 2. Taking TDF/XTC/EFV or NVP based ART 3. Male or female, age 18 or over 4. Ability and willingness to provide informed consent and willingness to comply with the requirements of the protocol, including being observed for 144 weeks on study, and complete all scheduled appointments and lab draws according to the national treatment guidelines and study protocol
Exclusion criteria
Exclusion criteria: Participants will be excluded from participation if they meet any of the following criteria 1. HIV-2 infection 2. Signs or symptoms consistent with established cirrhosis 3. Pregnant or lactating or those who are actively trying to conceive, or who are not using a consistent and reliable method of birth control 4. Severe chronic diarrhoea lasting for more than 30 consecutive days at time of screening 5. Active Tuberculosis and on Rifampicin based anti-tuberculous therapy 6. History of any chronic or acute illness or other condition that in the opinion of the investigator would interfere with the conduct or completion of the study 7. Receiving a prohibited medication for treatment of another medical condition 8. Current enrolled in an experimental protocol, or is receiving an experimental medication or vaccine 9. Current alcohol abuse or illicit drug use that in the opinion of the investigator may interfere with the patient’s ability to comply with the protocol requirements 10. History or current diagnosis of a psychiatric illness or major depression 11. Exhibition non-adherence to prior medical care and treatments 12. ALT > 2.5 times the upper limit of normal at baseline 13. Creatinine clearance <50 ml/min at study enrolment 14. Compulsory detention (i.e. involuntary incarceration) at the time of screening and enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Virologic Endpoints •HIV-1 plasma RNA >1,000 copies/mL at week 144 2.Toxicity Endpoints •Grade 3 or 4 adverse event requiring discontinuation of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Virologic Endpoints • HIV-1 plasma RNA >1,000 copies/mL at weeks 24,48, 72, 96 and 144 • HIV-1 plasma RNA >50 copies/mL at weeks 24,48, 72, 96 and 144 • Presence of genotypic resistance mutations at the time of Virologic failure and/or week 48 in patients with a viral load > 1,000 copies/mL 2. Toxicity Endpoints • Grade 2 adverse event requiring medical intervention and/or therapy ;3. To compare immunologic response (CD4 T cell increase) at 24 and 48 weeks among clients switched from TDF/XTC/EFV or NVP to TDF or TAF/XTC/ DTG with undetectable viral load to those with detectable viral load at the time of switch 4. To compare immunologic response (CD4 T cell increase) at 72,96 and 48 weeks among clients switched from TDF/XTC/EFV or NVP to TDF or TAF/XTC/ DTG with undetectable viral load to those with detectable viral load at the time of switch 5. To identify baseline genotypic drug resistance profiles among patients having plasma viral load values > 1,000 copies/mL switched from TDF/XTC/EFV or NVP to TDF or TAF/XTC/ DTG 6. To compare genotypic drug resistance patterns among patients having plasma viral load values > 1,000 copies/mL at 24, 48, 72, 96 and 144 weeks among patients with detectable viral loads (i.e. > 50 copies/mL) versus undetectable (i.e. 1000 at the time of switch | — |
Countries
Zambia, Zimbabwe
Contacts
Public ContactLameck Chirwa
Trial Coordinator
Outcome results
None listed