HIV InfectionsPhase 4SWAPNCT00647244
Efficacy and Safety of Switching From Retrovir to Tenofovir or Abacavir in HIV-infected Patients
A Phase 4 study testing Tenofovir disoproxil fumarate and Abacavir in people with HIV Infections, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
To evaluate the efficacy and safety of switching from Retrovir to Tenofovir or Abacavir in HIV-infected patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Tenofovir disoproxil fumarate and Abacavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2008to Aug 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prior treatment with abacavir or tenofovir
- Resistance towards abacavir or tenofovir
- Tissue type HLA-B5701
- Renal disease
- Diabetes Mellitus
- Osteoporosis
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Switching From AZT to Tenofovir
To evaluate the efficacy and safety of switching from Retrovir to Tenofovir or Abacavir in HIV-infected patients
- Conditions
- HIV Infections
- Being tested
- Tenofovir disoproxil fumarate, Abacavir
- Keywords
- Tenofovir, Abacavir, Antiretroviral therapy, HIV, Nucleoside analogue reverse transcriptase inhibitor
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir disoproxil fumarateDrug
Tenofovir disoproxil 245 mg oral tablet once daily
AbacavirDrug
Abacavir 300 mg oral tablet twice daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Tenofovir Receives: Drug: Tenofovir disoproxil fumarate |
| 2 | Active comparator | Abacavir Receives: Drug: Abacavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function measured by Cystatin-C and creatinine clearance
Measured: Weeks 0, 4, 8, 12, 24, 24, 48, 96
Levels of renal tubule function markers in blood and urine
Measured: Weeks 0, 12, 24, 48, 96
Bone mass assessed by DEXA
Measured: Weeks 0, 24, 48, 96
Levels of bone turnover markers in blood and urine
Measured: Weeks 0, 12, 24, 48, 96
Insulin resistance
Measured: Weeks 0, 12, 24, 48, 96
Changes in body composition assessed by patient questionnaire and standardized examination by physician
Measured: Weeks 0, 12, 24, 48, 96
Changes in subcutaneous adipose tissue assessed by DEXA
Measured: Week 0, 24, 48, 96
Secondary outcomes (5)
Patients with viral load < 40 copies/ml
Measured: Weeks 0, 4, 8, 12, 24, 48, 96
CD-4 cell count
Measured: Weeks 0, 4, 8, 12, 24, 48, 96
Fasting triglycerides, HDL and LDL
Measured: Weeks 0, 12, 24, 48, 96
Development of resistance mutations
Measured: Weeks 0, 12, 24, 48, 96
Development of adverse events and serious adverse events
Measured: Weeks 0, 4, 8, 12, 24, 48, 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00647244
- Sponsor's protocol ID
- SKS-HIV-002
- Other IDs
- EudraCT2007-004372-39
- Acronym
- SWAP
- Status last verified
- Dec 2010
- First submitted
- 26 Mar 2008
- Last updated
- 20 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rasmussen TA, Jensen D, Tolstrup M, Nielsen US, Erlandsen EJ, Birn H, Ostergaard L, Langdahl BL, Laursen AL. Comparison of bone and renal effects in HIV-infected adults switching to abacavir or tenofovir based therapy in a randomized trial. PLoS One. 2012;7(3):e32445. doi: 10.1371/journal.pone.0032445. Epub 2012 Mar 29.
PubMed 22479327Rasmussen TA, Tolstrup M, Melchjorsen J, Frederiksen CA, Nielsen US, Langdahl BL, Ostergaard L, Laursen AL. Evaluation of cardiovascular biomarkers in HIV-infected patients switching to abacavir or tenofovir based therapy. BMC Infect Dis. 2011 Oct 4;11:267. doi: 10.1186/1471-2334-11-267.
PubMed 21970555
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Switching From AZT to Tenofovir
- ClinicalTrials.gov ID
- NCT00647244
- Acronym / sponsor ID
- SWAP / SKS-HIV-002
- Conditions
- HIV Infections
- Keywords
- Tenofovir, Abacavir, Antiretroviral therapy, HIV, Nucleoside analogue reverse transcriptase inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 31 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of switching from Retrovir to Tenofovir or Abacavir in HIV-infected patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Tenofovir disoproxil fumarateTenofovir |
| 2 | Active comparator | Drug: AbacavirAbacavir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- Prior treatment with abacavir or tenofovir
- Resistance towards abacavir or tenofovir
- Tissue type HLA-B5701
- Renal disease
- Diabetes Mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir disoproxil fumarateTenofovir disoproxil 245 mg oral tablet once daily | Drug | 1 |
| AbacavirAbacavir 300 mg oral tablet twice daily | Drug | 2 |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2010.
- Derived from this study: PubMed 22479327Rasmussen TA, Jensen D, Tolstrup M, Nielsen US, Erlandsen EJ, Birn H, Ostergaard L, Langdahl BL, Laursen AL. Comparison of bone and renal effects in HIV-infected adults switching to abacavir or tenofovir based therapy in a randomized trial. PLoS One. 2012;7(3):e32445. doi: 10.1371/journal.pone.0032445. Epub 2012 Mar 29.
- Derived from this study: PubMed 21970555Rasmussen TA, Tolstrup M, Melchjorsen J, Frederiksen CA, Nielsen US, Langdahl BL, Ostergaard L, Laursen AL. Evaluation of cardiovascular biomarkers in HIV-infected patients switching to abacavir or tenofovir based therapy. BMC Infect Dis. 2011 Oct 4;11:267. doi: 10.1186/1471-2334-11-267.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tenofovir disoproxil fumarate and Abacavir in people with HIV Infections, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal function measured by Cystatin-C and creatinine clearance (time frame: Weeks 0, 4, 8, 12, 24, 24, 48, 96). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00647244, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2010.