Efficacy and Safety of Switching From Retrovir to Tenofovir or Abacavir in HIV-infected Patients
Phase 4
Completed
- Conditions
- HIV Infections
- Interventions
- Registration Number
- NCT00647244
- Lead Sponsor
- Aarhus University Hospital
- Brief Summary
To evaluate the efficacy and safety of switching from Retrovir to Tenofovir or Abacavir in HIV-infected patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- HIV-infection with undetectable viral load
- Antiretroviral treatment including Retrovir for more than three months
- If fertile female: Negative pregnancy test and use of safe contraception
- Negative HBs-antigen titer
Exclusion Criteria
- Prior treatment with abacavir or tenofovir
- Resistance towards abacavir or tenofovir
- Tissue type HLA-B5701
- Renal disease
- Diabetes Mellitus
- Osteoporosis
- Pregnant or lactating subjects
- Intravenous drug abuse
- Hypersensitivity towards drugs or active ingredient used
- ALAT > 5 times upper normal level
- Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Tenofovir disoproxil fumarate Tenofovir 2 Abacavir Abacavir
- Primary Outcome Measures
Name Time Method Renal function measured by Cystatin-C and creatinine clearance Weeks 0, 4, 8, 12, 24, 24, 48, 96 Levels of renal tubule function markers in blood and urine Weeks 0, 12, 24, 48, 96 Bone mass assessed by DEXA Weeks 0, 24, 48, 96 Levels of bone turnover markers in blood and urine Weeks 0, 12, 24, 48, 96 Insulin resistance Weeks 0, 12, 24, 48, 96 Changes in body composition assessed by patient questionnaire and standardized examination by physician Weeks 0, 12, 24, 48, 96 Changes in subcutaneous adipose tissue assessed by DEXA Week 0, 24, 48, 96
- Secondary Outcome Measures
Name Time Method Patients with viral load < 40 copies/ml Weeks 0, 4, 8, 12, 24, 48, 96 CD-4 cell count Weeks 0, 4, 8, 12, 24, 48, 96 Fasting triglycerides, HDL and LDL Weeks 0, 12, 24, 48, 96 Development of resistance mutations Weeks 0, 12, 24, 48, 96 Development of adverse events and serious adverse events Weeks 0, 4, 8, 12, 24, 48, 96
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Tenofovir's efficacy in HIV-infected patients previously treated with AZT?
How does Abacavir compare to Tenofovir in terms of virologic suppression and resistance profiles in HIV-1 subtype B infections?
Which biomarkers correlate with successful antiretroviral switching from AZT to Tenofovir in patients with thymidine analog mutations?
What are the long-term safety implications of switching from Retrovir to Tenofovir or Abacavir in HIV treatment-experienced patients?
How do Tenofovir and Abacavir combination regimens compare to standard-of-care NRTI backbones in managing HIV viral load and CD4+ T cell counts?
Trial Locations
- Locations (1)
Aarhus University Hospital
🇩🇰Århus N, Denmark
Aarhus University Hospital🇩🇰Århus N, Denmark