Efficacy and Safety of Switching From Retrovir to Tenofovir or Abacavir in HIV-infected Patients (SWAP)

Aarhus University Hospital

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: Abacavir; Drug: Tenofovir disoproxil fumarate

Study type: Interventional

Funder types: Other

Identifiers

NCT00647244

EudraCT2007-004372-39

SKS-HIV-002

Details and patient eligibility

About

To evaluate the efficacy and safety of switching from Retrovir to Tenofovir or Abacavir in HIV-infected patients

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

1

Active Comparator group

Description:

Tenofovir

Treatment:

Drug: Tenofovir disoproxil fumarate

2

Active Comparator group

Description:

Abacavir

Treatment:

Drug: Abacavir