PACTR201312000661337已完成未知
COMPARISON OF THE THERAPEUTIC EFFICACY AND ADVERSE EFFECTS PROFILE OF TENOFOVIR/LAMIVUDINE AND ZIDOVUDINE/LAMIVUDINE -BASED FIXED DOSE REGIMENS IN THE TREATMENT OF ANTIRETROVIRAL (ART) ¿NAÏVE HIV/AIDS PATIENTS IN ZARIA, NIGERIA.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- ABUTH
- 入组人数
- 198
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Year(s) 至 70 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
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