.A.
- Conditions
- -B20 Human immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseasesHuman immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseasesB20
- Registration Number
- PER-025-99
- Lead Sponsor
- HOSPITAL NACIONAL DOS DE MAYO,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
a) Male or female patients 18 years of age or older at the time of selection with good health.
b) HIV-1 RNA levels higher or equal to 5,000 copies / mL at the moment screening visit.
c) CD4 + count > 200 cells / mm3.
d) treatment-naïve patients (within 3 days antiretroviral therapy).
e) Informed consent.
f) Women of reproductive age with negative serum analysis of human chorionic gonadotropin (p-HCG) within 14 days prior to the first dose of the medication. (The effects of Emtricitabine on the fetus are unknown, but malformations have been observed in fetuses of animals treated with Efavirenz).
a) Consumption of alcohol or narcotics that, according to the principal investigator, would hinder the monitoring of the doses and evaluations of the protocol.
b) Pregnant or lactating women. (The consequences of the infant´s exposure to Emtricitabine are unknown).
c) Women of reproductive age who do not use effective barrier contraceptive methods during the study.
d) Clinical or laboratory abnormalities> Grade 3 toxicity, except for the following laboratory parameters, manifested in the screening visit and specified in the exclusion criteria:
• Hemoglobin <9.2 g / deciliter (di) for men and <8 .8 g / dl for women (without blood transfusion or erythrocytes within 21 days prior to analysis).
• Neutrophil count <1000 cells / mm3.
• Platelet count <75,000 cells / mm3.
• Aspartate-amino-transferase (AST) or alanine-amino-transferase (ALT)> 5 times the normal upper value (ULN.)
• Serum creatinine > 1.6 times ULN.
• serum amylase > 2.0 times the ULN (pancreatic portion). Normal pancreatic lipase or amylase levels are required if the total amylase is > 2.0 times the ULN.
• Total bilirubin > 1.6 mg / dl.
e) Peripheral neuropathy> Grade 2 or significant antecedents.
f) Malabsorption or chronic diarrhea (> Grade 2) within 30 days before the study or inability to eat properly (> 1 meal (s) per day) due to chronic nausea, emesis, or upset stomach or esophagus.
g) Acute or severe medical event within 30 days of the screening visit. Acute treatment should be completed 14 days before the start of the study.
h) Previous opportunistic AIDS infections, except pulmonary tuberculosis or gastrointestinal infection.
i) Patients currently under treatment against active tuberculosis.
j) Patients using derivatives of astemizole, cisapride, midazolam, triazolam or ergotamine.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Proportion of patients with viral load <400 copies / mL of HIV-1 RNA<br>Measure:Efficacy of emtricitabine compared to abacavir<br>Timepoints:Week 24 and 48<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Proportion of patients with lack of efficacy (Permanent suspension of treatment due to toxicity, interruption of patient follow-up, etc.), Progress of the disease, Virological failure.<br>Measure:Lack of effectiveness compared between treatment arms<br>Timepoints:Week 24 and 48<br>;<br>Outcome name:Proportion of patients with virological failure, viral RNA <400 copies / mL<br>Measure:Compare virological failure among treatment arms<br>Timepoints:Week 24 and 48<br>