HIV InfectionsPhase 3NCT00338390
Study to Evaluate Changes in CD4 on Replacing TDF With ABC or DDI+TDF With ABC+3TC
A Phase 3 study testing Abacavir, Didanosine and Abacavir+Lamivudine in people with HIV Infections, run by Hospital de Granollers at 21 sites in Spain.
Trial summary
The study aims to ascertain whether the sole replacement of tenofovir with abacavir once a day improves the immunological response obtained with tenofovir + ddI or whether it is better to perform a double replacement of tenofovir and ddI with abacavir + lamivudine (joint formulation) in a single daily dose to achieve… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Abacavir, Didanosine and Abacavir+Lamivudine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 21 sitesSpain
- Study dates
- Apr 2005to Feb 2007
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years.
- HIV-1 infected patients.
- Patients on triple HAART therapy including ddI + tenofovir plus a PI or NNRTI for at least 3 months.
- Patients with an undetectable HIV-1 viral load (< 50 copies RNA / mL or < centre's limit of detection) over the last 6 months.
- Not be on treatment with immunosuppressives, such as: hydroxyurea, interferon, ribavirin or cytostatics.
- Not be on treatment with interleukin-2 or other immunomodulators.
- Women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use a barrier contraceptive method during the study.
- Signature of the informed consent.
Who cannot join
- Incapacity to give informed consent.
- Bad adherence or treatment interruptions over the previous 6 months.
- Prior exposure to abacavir.
- HAART Therapy including ddI at a dose of 400mg + tenofovir if weight > 60 kg or ddI 250 mg + tenofovir if weight < 60 kg.
- Suspicion of cross resistances to abacavir and lamivudine.
- Hepatic or pancreatic analytical alterations 4 times above the limit of normality.
- Presence of opportunistic infections and/or recent tumours (< 6 months).
- Patients participating in another clinical trial.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Spain21 sites
Germans Trias i Pujol Hospital
Badalona, Barcelona, 08916
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036
Fundació Hospital de Granollers,
Barcelona, Granollers, 08400
Hospital Basurto
Bilbao, Bilabao, 48013
Hospital Sant Jaume de Calella
Calella, Barcelona, 08370
Hospital General de Castellón, , Castellón,
Castelló, Castello, 12004
Hospital Arquitecto Marcide
Ferrol, La Coruña, 15405
H. San Fco Borja Gandia
Gandia, Gandia, 46700
Hospital de Cabueñes
Gijón, Gijon, 33394
Hospital Clínico San Cecílio
Granada, Granada, 18012
H. del S.A.S. Jerez de la Frontera
Jerez de la Frontera, Cádiz, 11407
Fundación Jiménez Diaz
Madrid, Madrid, 28040
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Hospital de Mataró
Mataró, Barcelona, 08304
Hospital Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital Virgen Macarena
Seville, Sevilla, 41009
Hospital Joan XXIII
Tarragona, Tarragona, 43007
Hospital Sierrallana
Torrelavega, Cantabria, 39300
Hospital Arnau de Vilanova
Valencia, Valencia, 46015
Hospital Xeral de Vigo
Vigo, Vigo, 36204
About this study
Official title: Study of Changes in CD4 Lymphocyte Count in Patients With a HAART Regimen Including DDI + Tenofovir and With Viral Suppression Following the Replacement of Tenofovir With Abacavir Once Daily or Following the Double Replacement of DDI + Tenofovir With Abacavir + Lamivudine in a Single Tablet
The study aims to ascertain whether the sole replacement of tenofovir with abacavir once a day improves the immunological response obtained with tenofovir + ddI or whether it is better to perform a double replacement of tenofovir and ddI with abacavir + lamivudine (joint formulation) in a single daily dose to achieve these objectives.
Read the detailed description
Different works have shown a high rate of virological failure among patients on abacavir + lamivudine + tenofovir or ddI + 3TC + tenofovir, thus rendering the use of these combinations actively unadvisable.
Furthermore, recent studies have also shown that ABC+3TC are associated with a significantly higher increase in CD4 than the current treatment standard formed by AZT+3TC. This provides us with grounds to suppose that patients with TDF+ddI may recover their CD4 with ABC+3HT. Similarly, and recently, the existence of pharmacokinetic interactions between tenofovir + abacavir has begun to be questioned.
Finally, the replacement of tenofovir with abacavir or tenofovir + ddI with abacavir + lamivudine does not detract from the potency of HAART, the toxicity profile is different and their behaviour at mitochondrial level is similar.
This study aims to ascertain whether the sole replacement of tenofovir with abacavir once a day improves the immunological response obtained with tenofovir + ddI or whether it is better to perform a double replacement of tenofovir and ddI with abacavir + lamivudine (joint formulation) in a single daily dose to achieve these objectives.
- Conditions
- HIV Infections
- Being tested
- Abacavir, Didanosine, Abacavir+Lamivudine
- Keywords
- Antiretrovirals, CD4 cell count, toxicity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbacavirDrug
Also called n/h.
Change tenofovir to abacavir
DidanosineDrug
Also called n/h.
Increase didanosine dose to 400 mg/day if weight is > 60 Kg. or to 250mg/day if weight is < 60 kg.
Abacavir+LamivudineDrug
Also called n/h.
Change tenofovir and didanosine to abacavir + lamivudine (600mg+300 mg/day in one single tablet).
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Maintain antiretroviral treatment |
| 2 | Experimental | Change tenofovir to abacavir and increase didanosine dose to 400 mg/day if weight is > 60 Kg. or to 250mg/day if weight is < 60 kg. Receives: Drug: Abacavir; Drug: Didanosine |
| 3 | Experimental | Change tenofovir and didanosine to abacavir + lamivudine (600mg+300 mg/day in one single tablet). Receives: Drug: Abacavir+Lamivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients that increase their number of CD4 lymphocytes with regard to the baseline.
Measured: At 12, 24, 36 and 48 weeks
Secondary outcomes (6)
To evaluate the proportion of patients with viral load of HIV-1 <50 copies of the combinations studied during the follow-up period.
Measured: At 12, 24, 36 and 48 weeks.
Incidence of new clinical adverse events that appear .
Measured: during 48 weeks of follow-up
Evolution of the clinical adverse events that were already present at the time they were included in the study.
Measured: during the 48 weeks of follow-up
Rate of treatment drop-outs due to the appearance of adverse events
Measured: during the 48 weeks of follow-up
Incidence of new laboratory alterations that appear during the follow-up period (change in renal parameters, changes in lactate levels, modification of pancreatic enzymes, changes in lipid parameters).
Measured: during the follow-up period
Evolution of the laboratory alterations that were already present at the time they were included in the study.
Measured: during the 48 weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startApr 2005
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Granollers
- Sponsor type
- University, hospital or other
- Investigators
- Enric Pedrol, MD, PhD, Principal investigator, Fundació Hospital de Granollers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338390
- Sponsor's protocol ID
- EUROPA
- Other IDs
- 2004-003749-42, 2004
- Status last verified
- Oct 2008
- First submitted
- 15 Jun 2006
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Changes in CD4 Lymphocyte Count in Patients With a HAART Regimen Including DDI + Tenofovir and With Viral Suppression Following the Replacement of Tenofovir With Abacavir Once Daily or Following the Double Replacement of DDI + Tenofovir With Abacavir + Lamivudine in a Single Tablet
- ClinicalTrials.gov ID
- NCT00338390
- Acronym / sponsor ID
- EUROPA
- Conditions
- HIV Infections
- Keywords
- Antiretrovirals, CD4 cell count, toxicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Hospital de GranollersUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 20 Jun 2006 (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.
The study aims to ascertain whether the sole replacement of tenofovir with abacavir once a day improves the immunological response obtained with tenofovir + ddI or whether it is better to perform a double replacement of tenofovir and ddI with abacavir + lamivudine (joint formulation) in a single daily dose to achieve these objectives.
Detailed description
Different works have shown a high rate of virological failure among patients on abacavir + lamivudine + tenofovir or ddI + 3TC + tenofovir, thus rendering the use of these combinations actively unadvisable.
Furthermore, recent studies have also shown that ABC+3TC are associated with a significantly higher increase in CD4 than the current treatment standard formed by AZT+3TC. This provides us with grounds to suppose that patients with TDF+ddI may recover their CD4 with ABC+3HT. Similarly, and recently, the existence of pharmacokinetic interactions between tenofovir + abacavir has begun to be questioned.
Finally, the replacement of tenofovir with abacavir or tenofovir + ddI with abacavir + lamivudine does not detract from the potency of HAART, the toxicity profile is different and their behaviour at mitochondrial level is similar.
This study aims to ascertain whether the sole replacement of tenofovir with abacavir once a day improves the immunological response obtained with tenofovir + ddI or whether it is better to perform a double replacement of tenofovir and ddI with abacavir + lamivudine (joint formulation) in a single daily dose to achieve these objectives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Maintain antiretroviral treatment |
| 2 | Experimental | Drug: Abacavir, Drug: DidanosineChange tenofovir to abacavir and increase didanosine dose to 400 mg/day if weight is > 60 Kg. or to 250mg/day if weight is < 60 kg. |
| 3 | Experimental | Drug: Abacavir+LamivudineChange tenofovir and didanosine to abacavir + lamivudine (600mg+300 mg/day in one single tablet). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years.
- HIV-1 infected patients.
- Patients on triple HAART therapy including ddI + tenofovir plus a PI or NNRTI for at least 3 months.
- Patients with an undetectable HIV-1 viral load (< 50 copies RNA / mL or < centre's limit of detection) over the last 6 months.
- Not be on treatment with immunosuppressives, such as: hydroxyurea, interferon, ribavirin or cytostatics.
Key exclusion criteria (8 listed)
- Incapacity to give informed consent.
- Bad adherence or treatment interruptions over the previous 6 months.
- Prior exposure to abacavir.
- HAART Therapy including ddI at a dose of 400mg + tenofovir if weight > 60 kg or ddI 250 mg + tenofovir if weight < 60 kg.
- Suspicion of cross resistances to abacavir and lamivudine.
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 |
|---|---|---|
| AbacavirAlso: n/h.Change tenofovir to abacavir | Drug | 2 |
| DidanosineAlso: n/h.Increase didanosine dose to 400 mg/day if weight is > 60 Kg. or to 250mg/day if weight is < 60 kg. | Drug | 2 |
| Abacavir+LamivudineAlso: n/h.Change tenofovir and didanosine to abacavir + lamivudine (600mg+300 mg/day in one single tablet). | Drug | 3 |
Primary outcome
Proportion of patients that increase their number of CD4 lymphocytes with regard to the baseline.
Time frame: At 12, 24, 36 and 48 weeks
6 secondary outcomes
To evaluate the proportion of patients with viral load of HIV-1 <50 copies of the combinations studied during the follow-up period.
Time frame: At 12, 24, 36 and 48 weeks.
Incidence of new clinical adverse events that appear .
Time frame: during 48 weeks of follow-up
Evolution of the clinical adverse events that were already present at the time they were included in the study.
Time frame: during the 48 weeks of follow-up
Rate of treatment drop-outs due to the appearance of adverse events
Time frame: during the 48 weeks of follow-up
Incidence of new laboratory alterations that appear during the follow-up period (change in renal parameters, changes in lactate levels, modification of pancreatic enzymes, changes in lipid parameters).
Time frame: during the follow-up period
Evolution of the laboratory alterations that were already present at the time they were included in the study.
Time frame: during the 48 weeks of follow-up
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 24 Mar 2015.
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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.
Enric Pedrol, MD, PhD principal investigator
Fundació Hospital de Granollers
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Abacavir, Didanosine and Abacavir+Lamivudine in people with HIV Infections, run by Hospital de Granollers at 21 sites 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 8 inclusion and 8 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 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Proportion of patients that increase their number of CD4 lymphocytes with regard to the baseline. (time frame: At 12, 24, 36 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 24 Mar 2015.