Chronic human immunodeficiency virus (HIV) infection. Infections and Infestations Human immunodeficiency virus (HIV)
Conditions
Interventions
Switch nucleoside component of HAART to either Kivexa® or Truvada®.
Sponsors
Sponsor not yet defined (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with undetectable viral load at 48 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to virological failure 2. Incidence of clinical and laboratory adverse events leading to treatment discontinuation 3. Incidence of C events (CDC, 1993) 4. Change in CD4 from baseline 5. Change in triglyceride, cholesterol (total and high density lipoprotein [HDL] and low density lipoprotein [LDL]) 6. Mutations of resistance in failing patients | — |
Countries
Spain
Outcome results
None listed