HIV-Associated Lipodystrophy SyndromePhase 4NCT00646984
Strategies of Interruption/Reinitiation of Antiretroviral Therapy in HIV-Infected Patients With Lipodystrophy
A Phase 4 study testing Standard continuous antiretroviral therapy, CD-4 guided therapy interruption and Viral load driven treatment interruption in people with HIV-Associated Lipodystrophy Syndrome, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Aim: To assess the safety on the progression of HIV infection and the efficacy on the evolution of metabolic parameters and body fat of either viral load- or CD4 cell-driven strategies of intermittent treatment in chronically HIV-1-infected persons. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-Associated Lipodystrophy Syndrome
- What is being tested?
- Standard continuous antiretroviral therapy, CD-4 guided therapy interruption and Viral load driven treatment interruption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2002to Apr 2006
- 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-infected patients
- On stable antiretroviral therapy
- Viral load below 200 copies/ml
- CD4 above 450 cells/mcl during last 3 months
Who cannot join
- Weight variation higher than 10% compared with previous stable weight
- Active (CDC-C) opportunistic events
- Major depression or schizophrenia under psychiatric treatment
- Lack of clinical stability
- Pregnant women or planning pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Strategies of Interruption/Reinitiation of Antiretroviral Therapy in Response to Immunologic/Virologic Changes in HIV-Infected Patients With Lipodystrophy.
Aim: To assess the safety on the progression of HIV infection and the efficacy on the evolution of metabolic parameters and body fat of either viral load- or CD4 cell-driven strategies of intermittent treatment in chronically HIV-1-infected persons.
Design: Pilot, prospective, open, randomized, controlled 3-year study.
Read more
Setting and patients: University hospital. Patients with viral load <200 copies/mL and CD4 cell count >450/mm3 for at least the last 3 months. Three arms with 50 patients each, that will be randomized either to continue antiretroviral therapy, or to discontinue it as long as either HIV-1 RNA be lower than 30000 copies/mL or CD4 cell count be higher than 300/mm3.
Study end-points: evolution of plasma metabolic parameters, body fat, and bone mineral density; incidence of adverse effects due to antiretroviral therapy and symptoms consistent with acute retroviral syndrome; incidence of virological failure (plasma HIV-1 RNA >200 copies/mL while on therapy), immunological failure (CD4 cell count <200/mm3 while on therapy), or clinical failure (development of AIDS-defining illnesses); cost of antiretroviral therapy administered and time free of therapy in the arms assigned to intermittent treatment; and the evolution of T lymphocyte subpopulations and the development of proliferative and cytotoxic responses against HIV.
- Conditions
- HIV-Associated Lipodystrophy Syndrome
- Being tested
- Standard continuous antiretroviral therapy, CD-4 guided therapy interruption, Viral load driven treatment interruption
- Keywords
- Lipodystrophy, Treatment interruption, HIV
- Medical subject headings
- HIV-Associated Lipodystrophy Syndrome, Lipodystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard continuous antiretroviral therapyDrug
CD-4 guided therapy interruptionDrug
Stop antiretroviral therapy when CD-4 equal or above 350 and reinitiate when below 350
Viral load driven treatment interruptionDrug
Stop antiretroviral therapy when viral load below 30,000 copies/ml and reinitiate when equal or above 30,000 copies/ml
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Standard continuous antiretroviral therapy Receives: Drug: Standard continuous antiretroviral therapy |
| 2 | Experimental | CD-4 guided interruption arm Receives: Drug: CD-4 guided therapy interruption |
| 3 | Experimental | Viral load driven treatment interruption Receives: Drug: Viral load driven treatment interruption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb fat content measured by dual X-ray absorptiometry
Measured: 96 weekks
Secondary outcomes (1)
Other body composition analyses
Measured: 96 weeks
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 startJan 2002
- Primary completionApr 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-Associated Lipodystrophy SyndromeStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Investigators
- Jose M Gatell, MD, Study director, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646984
- Sponsor's protocol ID
- TARV-DEM-LD
- Other IDs
- AEM 01-0480
- Status last verified
- Mar 2008
- First submitted
- 26 Mar 2008
- Last updated
- 31 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Strategies of Interruption/Reinitiation of Antiretroviral Therapy in Response to Immunologic/Virologic Changes in HIV-Infected Patients With Lipodystrophy.
- ClinicalTrials.gov ID
- NCT00646984
- Acronym / sponsor ID
- TARV-DEM-LD
- Conditions
- HIV-Associated Lipodystrophy Syndrome
- Keywords
- Lipodystrophy, Treatment interruption, HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2006 (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.
Aim: To assess the safety on the progression of HIV infection and the efficacy on the evolution of metabolic parameters and body fat of either viral load- or CD4 cell-driven strategies of intermittent treatment in chronically HIV-1-infected persons.
Design: Pilot, prospective, open, randomized, controlled 3-year study.
Setting and patients: University hospital. Patients with viral load <200 copies/mL and CD4 cell count >450/mm3 for at least the last 3 months. Three arms with 50 patients each, that will be randomized either to continue antiretroviral therapy, or to discontinue it as long as either HIV-1 RNA be lower than 30000 copies/mL or CD4 cell count be higher than 300/mm3.
Study end-points: evolution of plasma metabolic parameters, body fat, and bone mineral density; incidence of adverse effects due to antiretroviral therapy and symptoms consistent with acute retroviral syndrome; incidence of virological failure (plasma HIV-1 RNA >200 copies/mL while on therapy), immunological failure (CD4 cell count <200/mm3 while on therapy), or clinical failure (development of AIDS-defining illnesses); cost of antiretroviral therapy administered and time free of therapy in the arms assigned to intermittent treatment; and the evolution of T lymphocyte subpopulations and the development of proliferative and cytotoxic responses against HIV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Standard continuous antiretroviral therapyStandard continuous antiretroviral therapy |
| 2 | Experimental | Drug: CD-4 guided therapy interruptionCD-4 guided interruption arm |
| 3 | Experimental | Drug: Viral load driven treatment interruptionViral load driven treatment interruption |
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-infected patients
- On stable antiretroviral therapy
- Viral load below 200 copies/ml
- CD4 above 450 cells/mcl during last 3 months
Key exclusion criteria (5 listed)
- Weight variation higher than 10% compared with previous stable weight
- Active (CDC-C) opportunistic events
- Major depression or schizophrenia under psychiatric treatment
- Lack of clinical stability
- Pregnant women or planning pregnancy
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 |
|---|---|---|
| Standard continuous antiretroviral therapy | Drug | 1 |
| CD-4 guided therapy interruptionStop antiretroviral therapy when CD-4 equal or above 350 and reinitiate when below 350 | Drug | 2 |
| Viral load driven treatment interruptionStop antiretroviral therapy when viral load below 30,000 copies/ml and reinitiate when equal or above 30,000 copies/ml | Drug | 3 |
Primary outcome
Limb fat content measured by dual X-ray absorptiometry
Time frame: 96 weekks
1 secondary outcome
Other body composition analyses
Time frame: 96 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 31 Mar 2008.
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.
Jose M Gatell, MD study director
Hospital Clinic of Barcelona
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 Standard continuous antiretroviral therapy, CD-4 guided therapy interruption and Viral load driven treatment interruption in people with HIV-Associated Lipodystrophy Syndrome, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 5 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 31 Mar 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 Spain. 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?
Limb fat content measured by dual X-ray absorptiometry (time frame: 96 weekks). 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 31 Mar 2008.