HIV InfectionsPhase 4NCT00356616
Immuno-Virological Efficacy of Combination With Trizivir +Tenofovir in Multiresistant HIV Patients
A Phase 4 study testing Trizivir (AZT+3HT+Abacavir) twice daily and Viread (300 mg Tenofovir disoproxil fumarate) once daily in people with HIV Infections, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial summary
To evaluate whether the combined therapy of two nucleosides plus one nucleotide (Trizivir + TDF) manages to keep CD4 lymphocytes stable in patients with HIV infection on antiretroviral treatment that present virological failure and multiple resistance to antiretrovirals. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Trizivir (AZT+3HT+Abacavir) twice daily and Viread (300 mg Tenofovir disoproxil fumarate) once daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2005to Jun 2007
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>= 18 years.
- HIV-1 infected patients.
- Patients on antiretroviral treatment including NTRI + PI +/- NNRTI +/- fusion inhibitors at inclusion in the study.
- Virological failure, defined as 2 determinations with viral load >1,000 copies/mL in the last 6 months, during stable HAART therapy over the previous 6 months.
- Genotype or phenotype resistance to three families of antiretrovirals (PI, NTRI and NNRTI) demonstrated in genotype study carried out in the last 48 weeks and defined as:
- 3 or more TAMS of the following: M41L, E44D, D67N, V118I, L210W, T215Y/F, K219Q/E.
Show all 13Show fewer
- Existence of the M184V mutation or probable presence in the cellular archives.
- 5 or more mutations that confer resistance to PI of the following: I10F/I/R/V, V32I, M46I/L, I54V/M/L, V82A/F/T/S/V, I84V/A/C, L90M.
- Existence of 1 or more mutations that confer resistance to NNRTI, or probable presence in the cellular archives of: K103N, Y181C/I/Y, G190S/A/G.
- CD4 lymphocytes >- 300 cells/mm3 in the last two determinations.
- Subject able to follow the treatment period.
- Acceptance of the study and signature of the informed consent form.
- 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.
Who cannot join
- Suspicion of previous incorrect adherence.
- Pregnancy or breastfeeding
- Suspicion of intolerance to any investigational drug.
- Record of any disease which, according to clinical criteria, may reoccur with the proposed change of therapy (sarcoma, lymphoma, etc).
- CD4 Nadir below 200 cel/mm3.
- Acute intercurrent disease or fever in the 15 days before inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label, Single-Centre, Randomised Pilot Study to Evaluate Immunovirological and Clinical Evolution of a Combination With Nucleoside Analogues/Nucleotides (Trizivir +Tenofovir) in Multiresistant Patients With Virological Failure
To evaluate whether the combined therapy of two nucleosides plus one nucleotide (Trizivir + TDF) manages to keep CD4 lymphocytes stable in patients with HIV infection on antiretroviral treatment that present virological failure and multiple resistance to antiretrovirals.
Read the detailed description
This study has been designed to determine whether the use of a regimen based exclusively on NTRI, containing tenofovir, zidovudine and lamivudine, is able to preserve immunological status in patients with detectable viral load for whom an efficacious salvage regimen cannot be designed, slowing the progression of the viral load and reducing antiretroviral treatment-associated toxicity. In order to complete the salvage regimen without increasing the number of tablets too much, Trizivir plus tenofovir as investigational treatment will be used.
- Conditions
- HIV Infections
- Being tested
- Trizivir (AZT+3HT+Abacavir) twice daily, Viread (300 mg Tenofovir disoproxil fumarate) once daily
- Keywords
- Antiretroviral treatment, virological failure, HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trizivir (AZT+3HT+Abacavir) twice dailyDrug
Trizivir (AZT+3HT+Abacavir) twice daily
Viread (300 mg Tenofovir disoproxil fumarate) once dailyDrug
Viread (300 mg Tenofovir disoproxil fumarate) once daily
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Trizivir+ Tenofovir 2/day Receives: Drug: Trizivir (AZT+3HT+Abacavir) twice daily; Drug: Viread (300 mg Tenofovir disoproxil fumarate) once daily |
| B | No intervention | antiretroviral treatment optimizated by genotyp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variations in the immune status of patients in each group throughout follow-up.
Measured: 48 weeks
Secondary outcomes (11)
Percentage of patients that increase viral load by > 0.5 log
Measured: weeks 12, 24, 36 and 48
Percentage of patients that increase viral load by > 100,000 copies/mL
Measured: weeks 12, 24, 36 and 48
Percentage of patients that present some clinical event, B or C classification according to the CDC.
Measured: during the 48 weeks of follow-up
Percentage of patients that present clinical or analytical adverse effects degree > 2 according to the WHO classification.
Measured: weeks 12, 24, 36 and 48
Percentage of patients that drop out of treatment.
Measured: weeks 12, 24, 36 and 48
Percentage of patients that drop out of the study due to intolerance or adverse effects.
Measured: weeks 12, 24, 36 and 48
Percentage of change in lipid determinations.
Measured: weeks 12, 24, 36 and 48 with regard to baseline
Percentage of patients that report changes, improvement or worsening in redistribution of body fat.
Measured: weeks 12, 24, 36 and 48
Percentage of patients that present adherence to the antiretroviral treatment > 95%.
Measured: weeks 12, 24, 36 and 48
Percentage of patients that present improvement in the quality of life (MOS-HIV) and satisfaction questionnaires.
Measured: weeks 12, 24, 36 and 48
Percentage of patients that present an increase in the number of active drugs.
Measured: at the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2006 (estimated)
- Study startSep 2005
- Primary completionJun 2007
- Study completionJun 2007
Why it stopped: terminated
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Investigators
- Bonaventura Clotet, MD,PhD, Principal investigator, LLuita contra la Sida Foundation-HIV Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00356616
- Sponsor's protocol ID
- TETRIZ
- Other IDs
- 2005-002203-17, 2005
- Status last verified
- Nov 2007
- First submitted
- 24 Jul 2006
- Last updated
- 29 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Single-Centre, Randomised Pilot Study to Evaluate Immunovirological and Clinical Evolution of a Combination With Nucleoside Analogues/Nucleotides (Trizivir +Tenofovir) in Multiresistant Patients With Virological Failure
- ClinicalTrials.gov ID
- NCT00356616
- Acronym / sponsor ID
- TETRIZ
- Conditions
- HIV Infections
- Keywords
- Antiretroviral treatment, virological failure, HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Collaborators
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Study start
- Sep 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 26 Jul 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.
To evaluate whether the combined therapy of two nucleosides plus one nucleotide (Trizivir + TDF) manages to keep CD4 lymphocytes stable in patients with HIV infection on antiretroviral treatment that present virological failure and multiple resistance to antiretrovirals.
Detailed description
This study has been designed to determine whether the use of a regimen based exclusively on NTRI, containing tenofovir, zidovudine and lamivudine, is able to preserve immunological status in patients with detectable viral load for whom an efficacious salvage regimen cannot be designed, slowing the progression of the viral load and reducing antiretroviral treatment-associated toxicity. In order to complete the salvage regimen without increasing the number of tablets too much, Trizivir plus tenofovir as investigational treatment will be used.
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: Trizivir (AZT+3HT+Abacavir) twice daily, Drug: Viread (300 mg Tenofovir disoproxil fumarate) once dailyTrizivir+ Tenofovir 2/day |
| B | No intervention | –antiretroviral treatment optimizated by genotyp |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age>= 18 years.
- HIV-1 infected patients.
- Patients on antiretroviral treatment including NTRI + PI +/- NNRTI +/- fusion inhibitors at inclusion in the study.
- Virological failure, defined as 2 determinations with viral load >1,000 copies/mL in the last 6 months, during stable HAART therapy over the previous 6 months.
- Genotype or phenotype resistance to three families of antiretrovirals (PI, NTRI and NNRTI) demonstrated in genotype study carried out in the last 48 weeks and defined as:
Key exclusion criteria (6 listed)
- Suspicion of previous incorrect adherence.
- Pregnancy or breastfeeding
- Suspicion of intolerance to any investigational drug.
- Record of any disease which, according to clinical criteria, may reoccur with the proposed change of therapy (sarcoma, lymphoma, etc).
- CD4 Nadir below 200 cel/mm3.
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 |
|---|---|---|
| Trizivir (AZT+3HT+Abacavir) twice dailyTrizivir (AZT+3HT+Abacavir) twice daily | Drug | A |
| Viread (300 mg Tenofovir disoproxil fumarate) once dailyViread (300 mg Tenofovir disoproxil fumarate) once daily | Drug | A |
Primary outcome
Variations in the immune status of patients in each group throughout follow-up.
Time frame: 48 weeks
11 secondary outcomes
Percentage of patients that increase viral load by > 0.5 log
Time frame: weeks 12, 24, 36 and 48
Percentage of patients that increase viral load by > 100,000 copies/mL
Time frame: weeks 12, 24, 36 and 48
Percentage of patients that present some clinical event, B or C classification according to the CDC.
Time frame: during the 48 weeks of follow-up
Percentage of patients that present clinical or analytical adverse effects degree > 2 according to the WHO classification.
Time frame: weeks 12, 24, 36 and 48
Percentage of patients that drop out of treatment.
Time frame: weeks 12, 24, 36 and 48
Percentage of patients that drop out of the study due to intolerance or adverse effects.
Time frame: weeks 12, 24, 36 and 48
Percentage of change in lipid determinations.
Time frame: weeks 12, 24, 36 and 48 with regard to baseline
Percentage of patients that report changes, improvement or worsening in redistribution of body fat.
Time frame: weeks 12, 24, 36 and 48
Percentage of patients that present adherence to the antiretroviral treatment > 95%.
Time frame: weeks 12, 24, 36 and 48
Percentage of patients that present improvement in the quality of life (MOS-HIV) and satisfaction questionnaires.
Time frame: weeks 12, 24, 36 and 48
Percentage of patients that present an increase in the number of active drugs.
Time frame: at the end of the study
Results and safety
The study was stopped early (reason given: terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2008.
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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.
Bonaventura Clotet, MD,PhD principal investigator
LLuita contra la Sida Foundation-HIV Unit
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 Trizivir (AZT+3HT+Abacavir) twice daily and Viread (300 mg Tenofovir disoproxil fumarate) once daily in people with HIV Infections, run by Germans Trias i Pujol Hospital 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 13 inclusion and 6 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: stopped early, as of the sponsor's last update on 29 Jan 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 was stopped early (reason given: terminated). Results are not available in the source record.
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?
Variations in the immune status of patients in each group throughout follow-up. (time frame: 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 29 Jan 2008.