HAART study
- Conditions
- HIV/AIDS
- Registration Number
- PACTR201312000661337
- Lead Sponsor
- ABUTH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 198
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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%.