STALEO

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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR201208000402280

Enrollment

520

Registered

2012-08-13

Start date

2011-11-07

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Interventions

New antiretroviral medicine regimen

Standard treatment (AZT+3TC+EFV)

Eligibility

Sex/Gender

All

Inclusion 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 > 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

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

Design outcomes

Primary

Measure	Time frame
viral load ;CD4 count;morbidity;adherence	—

Secondary

Measure	Time frame
adverse effects of antiretroviral drugs	—

Countries

Tanzania

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026