STALEO

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201208000402280
• Date of registration: 13/08/2012
• Primary sponsor: International Clinical Operations Health Research in Tanzania (ICOHRTA)
• Public title: STALEO
• Scientific title: The Effect of modified Stavudine and lamivudine containing regimen in antiretroviral therapy on clinical, immunological and virological outcomes in HIV-infected patients in Dar es Salaam, Tanzania. (STALEO TRIAL)
• Date of first enrolment: 2011-11-07
• Target sample size: 530
• Recruitment status: Closed to recruitment: follow up continuing
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201208000402280
• Study type: interventional
• Study design: Parallel: different groups receive different interventions at same time during study,; Randomised,; Simple randomisation using by using procedures such as coin-tossing or dice-rolling,; Sealed opaque envelopes,

Countries of recruitment

South Africa

Contacts

• Name: Muhammad Bakari
• Affiliation: Senior Lecture

• Name: Ferdinand Mugusi
• Affiliation: Senior Lecturer and My Main Supervisor (A trial is for PhD study)

Key inclusion & exclusion criteria

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 b 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

Age minimum: 18 Year
Age maximum: 80 Year
Gender: Both

Health Condition(s) or Problem(s) studied

HIV/AIDS
null

Primary Outcome(s)

adherence

CD4 count

morbidity

viral load

Secondary Outcome(s)

adverse effects of antiretroviral drugs

Source(s) of Monetary Support

Muhimbili University of Health and Allied Sciences (MUHAS) through ICORHTA