HIV/AIDS
Conditions
Interventions
Tenofovir/lamivudine + nevirapine or efavirenz
Zidovudine/lamivudine + Efavirenz or nevirapine
Sponsors
ABUTH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: HIV subjects who signed a written consent and satisfy the following criteria: 1. Aged ¿ 18 years 2. Had never received ART in the past either for treatment, post-exposure prophylaxis or PMTCT. 3. Had a baseline CD4 count of ¿350 cells/mm3 irrespective of WHO clinical staging; or WHO stage 3 or 4, irrespective of the CD4 count. 4. Seronegative for both HBsAg and HCV Ab. 5. Had the following baseline parameters: Hemogram ¿ 10g/dL, Platelet count ¿ 80,000/mm3, Absolute Neutrophil count ¿ 1000/mm3, Creatinine clearance ¿ 50mL/min (Cockcroft ¿Gault method), Serum Alanine transaminase level ¿ ×3 upper limit of normal.
Exclusion criteria
Exclusion criteria: HIV positive subjects who were: 1. Aged < 18 years old 2. Have documented history of renal disease or have a baseline estimated creatinine clearance of < 50mL/min. 3. On nephrotoxic or cytotoxic drugs 4. Have documented history of liver disease or have a baseline ALT ¿ x 3 ULN 5. Subjects who have symptomatic anemia or baseline Hemogram of < 10mg/dL.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To determine the proportion of patients on Tenofovir/lamivudine-arm compared to Zidovudine/lamivudine arm that had a virological response of ¿400 copies/mL in blood after 6 of HAART | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. To determine the proportion of patients on Tenofovir/lamivudine-arm compared to Zidovudine/lamivudine-arm that had an increase in baseline CD4+ cell count of ¿25 cells/mm3 after 6 months of HAART.;3. To determine the proportion of patients on Tenofovir/lamivudine regimen compared to that of Zidovudine/lamivudine who have adherence rate ¿ 95%. | — |
Countries
Nigeria
Contacts
Public Contactibrahim abdu-aguye
professor and Dean of medicine
Outcome results
None listed