Patients seropositive to Human Immunodeficiency Virus (HIV)
Conditions
Interventions
Group Efavirenz and then Sustiva®: Patients will receive a unique dose of 600 mg (a tablet) of Efavirenz by oral route between 8:00 and 9:00 am. After a washout period of 21 days, they will receive a
Tablets
Administration, Oral
Single Dose
Efavirenz,
Sustiva
Sponsors
Center for Pharmaceutical Research and Development, Havana, Cuba.
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1- HIV-positive patients diagnosed with two Western Blot tests positive (at least two HIV envelope proteins) which are covered by the sanatorium system or Ambulatory Care System (SAA). 2- Written informed consent. 3- Aged between 18-50 years. 4- Patients from any gender. 5- Patient’s weight: +/- 15% of ideal weight for height. 6- Not have evidence or history of diseases such as bronchial asthma, peptic or duodenal ulcer, liver failure, kidney failure, severe allergic reactions, atopic dermatitis, cardiovascular disorders, diabetes mellitus. 7- No opportunistic infections at the onset of the study. 8- Satisfactory physical examination. 9- Do not be ingesting medication at the time of the study or in the 15 days before the start of it. 10- Present vital signs values within the following reference ranges. Systolic blood pressure between 90 and 130 mm Hg and diastolic blood pressure between 60 and 80 mm Hg, heart rate between 60 to 100 beats per minute, respiratory rate between 12 to 20 breaths per minute. 11- Not having consumed alcohol, drinks containing xanthines (tea, coffee, and cola) and carbonated beverages three days before the start of each period and during it. 12- Patients of childbearing potential must use effective contraception up to three months after completion of treatment.
Exclusion criteria
Exclusion criteria: 1- Pregnancy and / or breastfeeding (pregnancy test should be performed at the time of entry). 2- Previous antirretroviral treatment or current criteria for antirretroviral therapy treatment (<350 CD4 + T cells / mm3). 3- Post-menopausal women (age 45 or older with at least two years of amenorrhea) or documented history of hysterectomy and / or annexectomy double sex. 4- Known history of allergies or drug, or to any component of the formulations studied (at the discretion of the investigator) hypersensitivity. 5- Refer viral disease in the last 7 days. 6- To be ingesting some medication 15 days (or for 5 half-lives) before the first dose of product research or nonprescribed or free drugs (OTC drugs) or herbal medicines / dietary supplements in a period seven days before the first dose of research products until the end of the study. 7- Serum creatinin values higher than 1.5 times the upper limit of the reference range. 8- Values of AST and ALT higher than 2 times the upper limit of the reference range. 9- Positive for hepatitis B and C and serology results. 10- History of alcoholism in the past 6 months (not less consumption ¼ bottle of rum or one (1) bottle of wine or three (3) beers in a higher frequency of twice a week. 11- Patients with a history of drug consumption dependence or drug abuse. 12- To be undergone major surgery within 6 months prior to baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic variable - Plasma levels of efavirenz (values expressed in mcg/mL): Measuring time: At the beginning and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 168 and 192 hours after administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Presence of adverse events-AE (distribution frequency for the appearance of adverse events (Yes, No), type of event (name of the AE), duration (time from appearance to end of the event), severity (severe, non-severe), intensity of AE (grades 1-5), causal relationship (remote, possible, probable, very probable), result of AE (recuperate, improvement, persist or sequels), attitude concerning the studied treatment (without changes, dose modification, temporal or definitive treatment discontinuation)). Measuring time: At each administration and during the whole study. - Clinical laboratory tests Hematology (hemoglobin, hematocrit, white blood cells counts, globular sedimentation rate, platelet count) and Biochemistry (glycemia, cholesterol, triglycerides, transaminases, alkaline phosphatase, urea, creatinine) determinations (numerical values as units of measurement for each determination). Measuring time: At baseline and end of the study. - Vital signs (body temperature in degrees centigrade, heart rate in beats / minute, blood pressure in mm Hg and respiration rate in breaths per minute). Measuring time: Prior to administration of the tablets, during the first 4 hours after administration, and at the end of each period. | — |
Countries
Cuba
Contacts
Public ContactIdrian Garcia Garcia
Center for Pharmaceutical Research and Development
Outcome results
None listed