FindTrial
Sign In

Effect and safety of switching from zidovudin to either tenofovir or abacavir in patients suffering from HIV. An open label study. - SWAP-TA

Effect and safety of switching from zidovudin to either tenofovir or abacavir in patients suffering from HIV. An open label study. - SWAP-TA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-004372-39-DK
Enrollment
Unknown
Registered
2007-09-24
Start date
2007-11-05
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Interventions

Trade Name: Kivexa Pharmaceutical Form: Tablet Trade Name: Ziagen Pharmaceutical Form: Transdermal patch Trade Name: Truvada Pharmaceutical Form: Tablet Trade Name: Viread Pharmaceutical Form: Tabl

Sponsors

Department of Infectious Diseases, Aarhus University Hospital, Skejby
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: HIV patients with a viral load below the level of detection and a treatment that includes zidovudin for a minimum of 3 months. Age >= 18 years If fertile female: Negative pregnancy test If fertile female: Safe anticonceptional method Negative HBs antigen test within 3 months prior to inclusion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Previous treatment with abacavir or tenofovir Pevious genotypic resistance examination compatible with resistance to abacavir or tenofovir Tissue type HLA_B5701 Known renal disease Untreated hypertension Known diabetes mellitus Known osteoporosis Pregnant or nursing women Illegal drug abuse Alcohol abuse ALT > 5 x uln Allergiy drugs used or contents of tablets

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the safety and effect of switching from zidovudin to either tenofovir or abacavir in patients suffering from HIV. Primary endpoints: Renal function Bone mass and bone modulation Lipoatrophy;Secondary Objective: CD count at week 96 compared to baseline Lipid profile Viral load Resistance mutations Frequency of serious unintended events Compliance - in the two arms over the course of 96 weeks.;Primary end point(s): Renal function at week 0, 8, 12, 24, 48 and 96. Bome mass and bone modulation at week 0, 12, 24, 48 and 96. Lipoatrophy at week 0, 12, 24, 48 and 96 (questionaire, dexascan and examination)—

Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026