HIV infection
Conditions
Interventions
Two groups:Efavirenz 400mg orally daily versus 600mg orally daily, in combination with other anti-retrovirals, 4 months
Sponsors
School of Pharmacy, Chinese University of Hong Kong
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) HIV-infected adults older than 18 years old; 2) Stable CD4 T-cell counts (over 200 cells per uL) and undetectable viral load (plasma HIV-1 RNA < 75 copies per mL); 3) on HAART containing standard dose EFV and 2 nucleoside/nucleotide reverse transcriptase inhibitors (e.g. tenofovir and emtricitabine).
Exclusion criteria
Exclusion criteria: 1) pregnant or nursing mothers; 2) have concurrent opportunistic infection or malignant disease, or any AIDS-defining illness; 3) on treatment or prophylaxis for an opportunistic infection; 4) have inadequate renal function (estimated creatinine clearance of <50 mL/min) or significantly deranged laboratory tests (e.g. ALT 1.5*upper limit of normal); 5) have documented non-adherence to study medications or HAART or documented history of illicit substance abuse; 6) illiterate or unable to communicate with study team; or 7) unable or refuse to participate or give consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subject having sufficient viral suppression, viral load < 75 copies per mL, 4 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentration of efavirenz, 4 months;sleep scale;occurrence of adverse effects or discontinuation; | — |
Countries
China
Contacts
Public ContactTeddy Lam
School of Pharmacy, Chinese University of Hong Kong
Outcome results
None listed