HIVPhase 2NCT00270556
Phase II Comparator Study of Substitution of Tenofovir or Abacavir Receiving Thymidine Analogue as Part of HAART.
A Phase 2 study testing tenofovir disoproxil fumarate and Abacavir in people with HIV, run by Gilead Sciences.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- tenofovir disoproxil fumarate and Abacavir
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Oct 2004
- 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 less than or equal to 18 years of age. 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. Able to understand and provide written informed consent in the opinion of the investigator. Subjects have clinical lipoatrophy at greater then or equal to 1 body/facial site in the investigator's opinion. Subjects currently receiving nucleoside analogue regimen including stavudine (d4T) or zidovudine (ZDV). Subjects who are stable on current therapy for greater than or equal to 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 less than 50 copies/mL on 2 consecutive occasions including most recent clinic attendance.
Who cannot join
- Subjects who are unlikely to complete the 48 week trial period. Currently active opportunistic disease or documented wasting syndrome. Currently receiving chemotherapy for malignancy. Subjects who are unlikely to retain viral response after switching based on treatment or transmission history. Currently receiving an insulin sensitising agent (glitazone or metformin). Anabolic steriods in the last 16 weeks other than testosterone at replacement doses (less than or equal to 250 mg/2 weekly). Growth hormone use in the last 16 weeks. Statin therapy (HMG CoA reductase inhibitor) commenced in the last 16 weeks (patients stable on statins may be included). Current alcohol or illicit drug use which may interfer 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 labeling will result in clinically significant interactions with tenofovir or abacavir. Pregnant or breast feeding. Previously received more than 3 months zidovudine monotherapy.
About this study
Official title: Phase II, Open-Label,Randomised, Comparator Study of Substitution w/Tenofovir or Abacavir in HIV-1 Infected Individuals, w/Viral Load Less 50 Copies/mL, Receiving a Thymidine Analogue (Zidovudine or Stavudine) as Part of HAART.
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 tryglicerides.
Read the detailed description
A previous study substituting zidovudine or stavudine to abacavir in patients with severe or moderate lipoatrophy has shown an increase in limb fat (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 tryglicerides.
- Conditions
- HIV
- Being tested
- tenofovir disoproxil fumarate, Abacavir
- Keywords
- Treatment Experienced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tenofovir disoproxil fumarateDrug
AbacavirDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2005 (estimated)
- Study startJan 2003
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Claudio Avila, MD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00270556
- Sponsor's protocol ID
- GS-02-1008
- Status last verified
- Apr 2008
- First submitted
- 23 Dec 2005
- Last updated
- 10 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Open-Label,Randomised, Comparator Study of Substitution w/Tenofovir or Abacavir in HIV-1 Infected Individuals, w/Viral Load Less 50 Copies/mL, Receiving a Thymidine Analogue (Zidovudine or Stavudine) as Part of HAART.
- ClinicalTrials.gov ID
- NCT00270556
- Acronym / sponsor ID
- GS-02-1008
- Conditions
- HIV
- Keywords
- Treatment Experienced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Study completion
- Oct 2004
- First posted
- 28 Dec 2005 (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.
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 tryglicerides.
Detailed description
A previous study substituting zidovudine or stavudine to abacavir in patients with severe or moderate lipoatrophy has shown an increase in limb fat (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 tryglicerides.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who are male or female less than or equal to 18 years of age. 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. Able to understand and provide written informed consent in the opinion of the investigator. Subjects have clinical lipoatrophy at greater then or equal to 1 body/facial site in the investigator's opinion. Subjects currently receiving nucleoside analogue regimen including stavudine (d4T) or zidovudine (ZDV). Subjects who are stable on current therapy for greater than or equal to 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 less than 50 copies/mL on 2 consecutive occasions including most recent clinic attendance.
Key exclusion criteria (1 listed)
- Subjects who are unlikely to complete the 48 week trial period. Currently active opportunistic disease or documented wasting syndrome. Currently receiving chemotherapy for malignancy. Subjects who are unlikely to retain viral response after switching based on treatment or transmission history. Currently receiving an insulin sensitising agent (glitazone or metformin). Anabolic steriods in the last 16 weeks other than testosterone at replacement doses (less than or equal to 250 mg/2 weekly). Growth hormone use in the last 16 weeks. Statin therapy (HMG CoA reductase inhibitor) commenced in the last 16 weeks (patients stable on statins may be included). Current alcohol or illicit drug use which may interfer 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 labeling will result in clinically significant interactions with tenofovir or abacavir. Pregnant or breast feeding. Previously received more than 3 months zidovudine monotherapy.
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 fumarate | Drug | – |
| Abacavir | Drug | – |
Primary outcome
Not reported in the source record.
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 10 Apr 2008.
- Gilead websiteLink provided by the sponsor.
- Study ResultsLink provided by the sponsor.
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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.
Claudio Avila, MD study director
Gilead Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tenofovir disoproxil fumarate and Abacavir in people with HIV, run by Gilead Sciences.
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 1 inclusion and 1 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 10 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
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.
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 10 Apr 2008.