HIV InfectionsPhase 4NCT00685191
HIV-1 Viral Dynamics in Subjects Initiating Raltegravir Therapy in Spain
A Phase 4 study testing Salvage antiretroviral therapy including raltegravir in people with HIV Infections, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial summary
The study purpose is to investigate plasma HIV-1 RNA dynamics in subjects initiating raltegravir-based salvage therapy and quantify the corresponding changes in levels of cellular HIV-1 DNA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Salvage antiretroviral therapy including raltegravir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2008to Oct 2009
- 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
- Patients who have limited or no treatment options due to extensive antiretroviral drug resistance or drug intolerance.
- Subjects initiating raltegravir plus another fully active antiretroviral drug.
Who cannot join
- Pregnancy, or fertile women willing to be pregnant.
- Active substance abuse or major psychiatric disease.
Trial locations and contacts
1 site in 1 country.
About this study
The study purpose is to investigate plasma HIV-1 RNA dynamics in subjects initiating raltegravir-based salvage therapy and quantify the corresponding changes in levels of cellular HIV-1 DNA.
Read the detailed description
First- and second-phase decay rates of plasma HIV-1 RNA and changes in the intracellular levels of HIV-1 proviral DNA and LTR circles will be measured in subjects starting salvage antiretroviral therapy including raltegravir in Spain.
- Conditions
- HIV Infections
- Being tested
- Salvage antiretroviral therapy including raltegravir
- Keywords
- Raltegravir, HIV, dynamics, viral load, Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salvage antiretroviral therapy including raltegravirDrug
Also called RAL
Initiation of raltegravir-including salvage antiretroviral therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | HIV-1-infected subjects initiating raltegravir-including salvage therapy Receives: Drug: Salvage antiretroviral therapy including raltegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in viral load from day 0 to 7
Measured: 1 week
Secondary outcomes (1)
Intracellular levels of HIV-1 proviral DNA and LTR circles
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startJun 2008
- Primary completionApr 2009
- Study completionOct 2009
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
- Responsible party
- Sponsor
- Investigators
- Bonaventura Clotet, MD,PhD, Principal investigator, Hospital U. Germans Trias i Pujol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685191
- Sponsor's protocol ID
- ITHACA
- Status last verified
- Dec 2019
- First submitted
- 23 May 2008
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV-1 Viral Dynamics in Subjects Initiating Raltegravir Therapy in Spain
- ClinicalTrials.gov ID
- NCT00685191
- Acronym / sponsor ID
- ITHACA
- Conditions
- HIV Infections
- Keywords
- Raltegravir, HIV, dynamics, viral load, Treatment Experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 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
- Jun 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 28 May 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.
The study purpose is to investigate plasma HIV-1 RNA dynamics in subjects initiating raltegravir-based salvage therapy and quantify the corresponding changes in levels of cellular HIV-1 DNA.
Detailed description
First- and second-phase decay rates of plasma HIV-1 RNA and changes in the intracellular levels of HIV-1 proviral DNA and LTR circles will be measured in subjects starting salvage antiretroviral therapy including raltegravir in Spain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Salvage antiretroviral therapy including raltegravirHIV-1-infected subjects initiating raltegravir-including salvage therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who have limited or no treatment options due to extensive antiretroviral drug resistance or drug intolerance.
- Subjects initiating raltegravir plus another fully active antiretroviral drug.
Key exclusion criteria (2 listed)
- Pregnancy, or fertile women willing to be pregnant.
- Active substance abuse or major psychiatric disease.
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 |
|---|---|---|
| Salvage antiretroviral therapy including raltegravirAlso: RALInitiation of raltegravir-including salvage antiretroviral therapy | Drug | 1 |
Primary outcome
Change in viral load from day 0 to 7
Time frame: 1 week
1 secondary outcome
Intracellular levels of HIV-1 proviral DNA and LTR circles
Time frame: 24 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 4 Dec 2019.
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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
Hospital U. Germans Trias i Pujol
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 Salvage antiretroviral therapy including raltegravir 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 2 inclusion and 2 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 4 Dec 2019. 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?
Change in viral load from day 0 to 7 (time frame: 1 week). 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 4 Dec 2019.