MedPath

STALEO

Not Applicable
Conditions
HIV/AIDS
Registration Number
PACTR201208000402280
Lead Sponsor
International Clinical Operations Health Research in Tanzania (ICOHRTA)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Other
Sex
All
Target Recruitment
520
Inclusion Criteria

¿HIV-infected as documented by positive HIV antibody test.
¿Subject is at least 18 years of age at the day of the first HIV clinic visits.
¿Able to give informed consent
¿CD4+ T lymphocyte count less or equal to 350 cell/mm3 or those indicated for antiretroviral therapy by WHOstaging criterio
¿Karnofsky score > 40.
¿Willing and able to regularly attend the HIV clinic at the designated sites.
¿Patient note exposed to antiretroviral drugs as determined by self reporting.
¿Women with a negative urinary pregnancy during enrolment

Exclusion Criteria

¿Women expected to bear a child during the study period as determined during initial assessment.
¿A history of severe psychiatric disease such as psychosis, schizophrenia, depression,
¿Patient with clinically confirmed neuropathy and lipodystrophy

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
viral load ;CD4 count;morbidity;adherence
Secondary Outcome Measures
NameTimeMethod
adverse effects of antiretroviral drugs
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