Efficacy and Safety of Switching From Retrovir to Tenofovir or Abacavir in HIV-infected Patients (SWAP)
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ClinicalTrials.gov Identifier: NCT00647244 |
Recruitment Status
:
Completed
First Posted
: March 31, 2008
Last Update Posted
: December 20, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Tenofovir disoproxil fumarate Drug: Abacavir | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety of Switching From AZT to Tenofovir |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | August 2010 |
Actual Study Completion Date : | August 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Tenofovir
|
Drug: Tenofovir disoproxil fumarate
Tenofovir disoproxil 245 mg oral tablet once daily
|
Active Comparator: 2
Abacavir
|
Drug: Abacavir
Abacavir 300 mg oral tablet twice daily
|
- Renal function measured by Cystatin-C and creatinine clearance [ Time Frame: Weeks 0, 4, 8, 12, 24, 24, 48, 96 ]
- Levels of renal tubule function markers in blood and urine [ Time Frame: Weeks 0, 12, 24, 48, 96 ]
- Bone mass assessed by DEXA [ Time Frame: Weeks 0, 24, 48, 96 ]
- Levels of bone turnover markers in blood and urine [ Time Frame: Weeks 0, 12, 24, 48, 96 ]
- Insulin resistance [ Time Frame: Weeks 0, 12, 24, 48, 96 ]
- Changes in body composition assessed by patient questionnaire and standardized examination by physician [ Time Frame: Weeks 0, 12, 24, 48, 96 ]
- Changes in subcutaneous adipose tissue assessed by DEXA [ Time Frame: Week 0, 24, 48, 96 ]
- Patients with viral load < 40 copies/ml [ Time Frame: Weeks 0, 4, 8, 12, 24, 48, 96 ]
- CD-4 cell count [ Time Frame: Weeks 0, 4, 8, 12, 24, 48, 96 ]
- Fasting triglycerides, HDL and LDL [ Time Frame: Weeks 0, 12, 24, 48, 96 ]
- Development of resistance mutations [ Time Frame: Weeks 0, 12, 24, 48, 96 ]
- Development of adverse events and serious adverse events [ Time Frame: Weeks 0, 4, 8, 12, 24, 48, 96 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00647244
Denmark | |
Aarhus University Hospital | |
Århus N, Denmark, 8200 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Alex Lund Laursen, MD, PhD, DmSC, Department of Infectious Diseases, Aarhus University Hospital, Denmark |
ClinicalTrials.gov Identifier: | NCT00647244 History of Changes |
Other Study ID Numbers: |
SKS-HIV-002 EudraCT2007-004372-39 |
First Posted: | March 31, 2008 Key Record Dates |
Last Update Posted: | December 20, 2010 |
Last Verified: | December 2010 |
Keywords provided by University of Aarhus:
Tenofovir Abacavir Antiretroviral therapy HIV Nucleoside analogue reverse transcriptase inhibitor |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Tenofovir Abacavir |
Dideoxynucleosides Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents Antimetabolites |