LipodystrophyPhase 2RAVENCT00647946
Study to Evaluate Changes in Limb Fat When Switching From a Thymidine Analogue
A Phase 2 study testing tenofovir DF and abacavir 300mg twice daily in people with Lipodystrophy, run by Gilead Sciences at 1 site in United Kingdom.
Trial summary
A previous study substituting zidovudine or stavudine to abacavir in patients with severe or moderate lipoatrophy has shown an increase in limb fat by DEXA. This study was conducted over a 24-week period and although improved outcomes were documented by objective measures, DEXA scans, subjective observation did not… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lipodystrophy
- What is being tested?
- tenofovir DF and abacavir 300mg twice daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2003to Feb 2006
- Phase
- Phase 2
- 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
- Subjects who are male or female > 18 years of age
- Subjects who are HIV-1 infected as documented by a licensed HIV-1 antibody ELISA
- Female subjects of childbearing potential must have a negative serum pregnancy test (beta-HCG) within 28 days of trial day 1. Women of childbearing potential must agree to use a barrier method of contraception
- Female subjects must not be pregnant or lactating
- Subjects who in the opinion of the investigator have the ability to understand and provided written informed consent to participate in the trial
- Subjects who in the opinion of the investigator have clinical lipoatrophy at > 1 body/facial site
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- Subjects currently receiving nucleoside analogue regimen including stavudine (d4T) or zidovudine (ZDV)
- Subjects who are stable on current therapy for >16 weeks
- Subjects with no prior exposure to tenofovir, abacavir, or adefovir
- Subjects with no known K65R, 69S mutations or 3 or more thymidine analogue mutations
- Subjects with documented viral load <50 copies/ml on 2 consecutive occasions including most recent clinic attendance
Who cannot join
- Subjects who in the investigator's opinion are unlikely to complete the 48 week trial period
- Currently active opportunistic disease or documented wasting syndrome
- Currently receiving chemotherapy for malignancy
- Subjects who in the opinion of the investigator are unlikely to retain viral response after switching based on treatment or transmission history
- Currently receiving an insulin sensitising agent (glitazone or metformin)
- Anabolic steroids in the last 16 weeks other than testosterone at replacement doses (<250mg/2 weekly)
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- Growth hormone use in the last 16 weeks
- Statin therapy (HMG CoA reductase inhibitor) commenced in the last 16 weeks (patients stable on statins my be included)
- Current alcohol or illicit drug use which, in the opinion of the investigator, may interfere with the subjects' ability to comply with the dosing schedule and protocol evaluations
- Receiving concurrent medications that - in the opinion of the investigator and according to drug product labelling - will result in clinically significant interactions with tenofovir or abacavir
- Pregnant or breast feeding
- Previously received more than 3 months zidovudine monotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Open-Label, Multicentre, Randomised, Comparator Study of Substitution With Tenofovir or Abacavir in HIV-1 Infected Individuals, With a Viral Load < 50 Copies/mL, Receiving a Thymidine Analogue (Zidovudine or Stavudine) as Part of Their Highly Active Antiretroviral Therapy (HAART)
A previous study substituting zidovudine or stavudine to abacavir in patients with severe or moderate lipoatrophy has shown an increase in limb fat by DEXA. This study was conducted over a 24-week period and although improved outcomes were documented by objective measures, DEXA scans, subjective observation did not correspond. Longer-term follow up of these patients is required.
This 48 week study is designed to compare the substitution of the thymidine analogues zidovudine (ZDV) or stavudine (D4T) with either tenofovir DF or abacavir, in patients treated with highly active antiretroviral therapy (HAART), and show improved outcomes on total limb fat mass, improved body shape by dual energy x-ray absorptiometry (DEXA) and computed tomography (CT) scans and improved cholesterol and triglycerides.
Read the detailed description
This is a phase II, open-label, multicentre, randomised, two-arm study of 48 weeks duration. One hundred HIV infected individuals who have documented lipodystrophy at > 1 body/facial site and currently receiving zidovudine (ZDV) or stavudine (d4T) will be recruited.
- Conditions
- Lipodystrophy
- Being tested
- tenofovir DF, abacavir 300mg twice daily
- Keywords
- lipodystrophy
- Medical subject headings
- Lipodystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tenofovir DFDrug
tenofovir DF 300mg once daily along with the other antiviral drugs
abacavir 300mg twice dailyDrug
abacavir 300mg twice daily along with the other antiviral drugs
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Stop zidovudine (ZDV) or stavudine (d4T) and start tenofovir DF 300mg once daily along with the other antiviral drugs that are used as part of their HAART regimen Receives: Drug: tenofovir DF |
| B | Active comparator | Stop zidovudine (ZDV) or stavudine (d4T) and start abacavir 300mg twice daily along with the other antiviral drugs that are used as part of their HAART regimen Receives: Drug: abacavir 300mg twice daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total limb fat mass by DEXA scan
Measured: 24 and 48 weeks
Secondary outcomes (7)
Change in VAT by single slice L4 abdominal CT scan
Measured: 24 and 48 weeks
Change in viral load measurements and CD4 cell count
Measured: 24 and 48 Weeks
Change in fasting cholesterol and triglycerides
Measured: 24 and 48 Weeks
Change in blood insulin and fasting glucose
Measured: 24 and 48 Weeks
Change in blood lactate and anion gap
Measured: 24 and 48 Weeks
Change in bone mineral density by DEXA scan
Measured: 24 and 48 Weeks
Incidence of adverse events
Measured: Upto 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startFeb 2003
- Primary completionOct 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipodystrophyStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Geoff Cotton, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00647946
- Sponsor's protocol ID
- GS-UK-104-1008
- Acronym
- RAVE
- Status last verified
- Jun 2008
- First submitted
- 27 Mar 2008
- Last updated
- 30 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Multicentre, Randomised, Comparator Study of Substitution With Tenofovir or Abacavir in HIV-1 Infected Individuals, With a Viral Load < 50 Copies/mL, Receiving a Thymidine Analogue (Zidovudine or Stavudine) as Part of Their Highly Active Antiretroviral Therapy (HAART)
- ClinicalTrials.gov ID
- NCT00647946
- Acronym / sponsor ID
- RAVE / GS-UK-104-1008
- Conditions
- Lipodystrophy
- Keywords
- lipodystrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Oct 2004 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 1 Apr 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.
A previous study substituting zidovudine or stavudine to abacavir in patients with severe or moderate lipoatrophy has shown an increase in limb fat by DEXA. This study was conducted over a 24-week period and although improved outcomes were documented by objective measures, DEXA scans, subjective observation did not correspond. Longer-term follow up of these patients is required.
This 48 week study is designed to compare the substitution of the thymidine analogues zidovudine (ZDV) or stavudine (D4T) with either tenofovir DF or abacavir, in patients treated with highly active antiretroviral therapy (HAART), and show improved outcomes on total limb fat mass, improved body shape by dual energy x-ray absorptiometry (DEXA) and computed tomography (CT) scans and improved cholesterol and triglycerides.
Detailed description
This is a phase II, open-label, multicentre, randomised, two-arm study of 48 weeks duration. One hundred HIV infected individuals who have documented lipodystrophy at > 1 body/facial site and currently receiving zidovudine (ZDV) or stavudine (d4T) will be recruited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: tenofovir DFStop zidovudine (ZDV) or stavudine (d4T) and start tenofovir DF 300mg once daily along with the other antiviral drugs that are used as part of their HAART regimen |
| B | Active comparator | Drug: abacavir 300mg twice dailyStop zidovudine (ZDV) or stavudine (d4T) and start abacavir 300mg twice daily along with the other antiviral drugs that are used as part of their HAART regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects who are male or female > 18 years of age
- Subjects who are HIV-1 infected as documented by a licensed HIV-1 antibody ELISA
- Female subjects of childbearing potential must have a negative serum pregnancy test (beta-HCG) within 28 days of trial day 1. Women of childbearing potential must agree to use a barrier method of contraception
- Female subjects must not be pregnant or lactating
- Subjects who in the opinion of the investigator have the ability to understand and provided written informed consent to participate in the trial
Key exclusion criteria (12 listed)
- Subjects who in the investigator's opinion are unlikely to complete the 48 week trial period
- Currently active opportunistic disease or documented wasting syndrome
- Currently receiving chemotherapy for malignancy
- Subjects who in the opinion of the investigator are unlikely to retain viral response after switching based on treatment or transmission history
- Currently receiving an insulin sensitising agent (glitazone or metformin)
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 DFtenofovir DF 300mg once daily along with the other antiviral drugs | Drug | A |
| abacavir 300mg twice dailyabacavir 300mg twice daily along with the other antiviral drugs | Drug | B |
Primary outcome
Change in total limb fat mass by DEXA scan
Time frame: 24 and 48 weeks
7 secondary outcomes
Change in VAT by single slice L4 abdominal CT scan
Time frame: 24 and 48 weeks
Change in viral load measurements and CD4 cell count
Time frame: 24 and 48 Weeks
Change in fasting cholesterol and triglycerides
Time frame: 24 and 48 Weeks
Change in blood insulin and fasting glucose
Time frame: 24 and 48 Weeks
Change in blood lactate and anion gap
Time frame: 24 and 48 Weeks
Change in bone mineral density by DEXA scan
Time frame: 24 and 48 Weeks
Incidence of adverse events
Time frame: Upto 48 weeks
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 30 Jun 2008.
- Study resultsLink provided by the sponsor.
Related trials for Lipodystrophy
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Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy
Lipodystrophy, Diabetes
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Generalized Lipodystrophy
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Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy
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Sexual Quality of Life in Female Patients With Lipodystrophy Syndromes or Turner's Syndrome: a Case-control Study
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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.
Geoff Cotton study director
Gilead Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tenofovir DF and abacavir 300mg twice daily in people with Lipodystrophy, run by Gilead Sciences at 1 site in United Kingdom.
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 11 inclusion and 12 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 30 Jun 2008. 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 United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in total limb fat mass by DEXA scan (time frame: 24 and 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2008.