AIDS, HIV Infections
Conditions
Keywords
HIV/AIDS
Brief summary
The purpose of this study is to evaluate whether a therapy with an all once daily regimen of efavirenz (EFV), didanosine (ddI)-EC and lamivudine (3TC) leads to improved outcomes, as measured by viral load, CD4 counts, adherence, safety, and tolerability.
Interventions
DRUGefavirenz; didanosine EC; lamivudine
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 18 years of age or older infected with HIV and weigh at least 40 kg. * Plasma HIV RNA viral load of 1000 copies/mL or greater and CD4 count of 100 cells/mL or greater * Be willing to use two forms of contraception throughout study * No previous exposure to antiretroviral (ARV) drugs
Exclusion criteria
* Pregnancy or breastfeeding * Physical or psychiatric disability * Proven or suspected acute hepatitis within 30 days prior to study entry * Active AIDS-defining opportunistic infection or disease * History of acute or chronic pancreatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimate efficacy of ddI-EC/3TC/EFV given QD determined by proportion of patients with plasma HIV-1 RNA <400 copies/mL at 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate proportion of patients with plasma HIV RNA <50 copies/mL at Weeks 24, 48, 72, and 96 | — |
| Determine viral suppression of plasma HIV RNA from change in baseline at week 48 | — |
| Determine proportion of patients whose HIV viral load doesn't drop to undetectable level within 24 weeks | — |
| Evaluate time to undetectable plasma HIV RNA | — |
| Evaluate proportion of patients demonstrating virologic breakthrough | — |
| Evaluate proportion of patients demonstrating virologic failure | — |
| Evaluate proportion of patients with plasma HIV RNA <400 copies/mL at Weeks 24, 48, 72, and 96. | — |
| Measure magnitude and durability of changes in CD4 cell counts | — |
| Evaluate patient adherence with QD regimen using pill counts and AMAF | — |
| Determine pattern and emergence of HIV genotype resistance mutations in patients experiencing virologic failure | — |
| Explore QoL changes using MOS-HIV health survey | — |
| Evaluate safety and tolerability of QD regimen | — |
| Evaluate time to virologic breakthrough and virologic failure | — |
Countries
United States
Outcome results
None listed