Comparison of two alternative combinations of nucleosides in HIV-1 infected patients with viral suppression on 3TC. Randomized, multicentre open trial.
- Conditions
- Chronic human immunodeficiency virus (HIV) infection.Infections and InfestationsHuman immunodeficiency virus (HIV)
- Registration Number
- ISRCTN61891868
- Lead Sponsor
- Sponsor not yet defined (Spain)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 300
1. Male and female
2. HIV-1-infected
3. Age 18 and above
4. On stable highly active antiretroviral therapy (HAART), including lamivudine (3TC) for at least last 3 months
5. Plasma viral load <200 copies/ml for at least 4 months
6. Written informed consent
1. Pregnancy, breastfeeding or intent to become pregnant during the study period
2. Active opportunistic infection requiring treatment by parenteral route
3. Creatinine (serum) >2 mg/dl
4. Current treatment with potentially nephrotoxic agents: aminoglicosides, amfotericin B, cidofovir, cisplatin, foscarnet, pentamidine IV
5. Treatment with adefovir, probenecid, interleukin-2, systemic steroids or investigational agents
6. Systemic antineoplastic chemotherapy
7. Any contraindication for study drugs
8. Prior failure on combinations including abacavir or tenofovir or with mutations of resistance to these drugs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with undetectable viral load at 48 weeks.
- Secondary Outcome Measures
Name Time Method 1. Time to virological failure<br>2. Incidence of clinical and laboratory adverse events leading to treatment discontinuation<br>3. Incidence of C events (CDC, 1993)<br>4. Change in CD4 from baseline<br>5. Change in triglyceride, cholesterol (total and high density lipoprotein [HDL] and low density lipoprotein [LDL])<br>6. Mutations of resistance in failing patients