HIV InfectionRAL-dynNCT00787774
Integrase Resistance Analysis in HIV Patients Who Interrupted Raltegravir Due to Incomplete Viral Suppression
A study testing resume raltegravir in people with HIV Infection, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Prospective study to evaluate the potential persistent viral effect of raltegravir in 20 treatment experienced HIV patients with incomplete viral suppression Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infection
- What is being tested?
- resume raltegravir
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2008to Jan 2010
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects on Raltegravir-containing regimen with confirmed virological failure (VL >500c/mL for > 3 months).
- Patients treated with a raltegravir-containing regimen for at least for 24 weeks.
- CD4 cell count > 50 cell/mm3.
- Adherence >90%, measured by short -self report questionnaire during the 3 months preceding the study entry.
- No reasonable additional therapeutic options
Who cannot join
- History or suspicion of alcohol or drug use which in the investigator's opinion would likely compromise subjects' safety and/or study procedures.
- A positive urine drug test for amphetamines, cocaine and opioids at two consecutive screenings (a positive drug test at study screening will be repeated at baseline).
- Life expectancy less than 6 months.
- Subject has any currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection 1993) with the following 2 exceptions:
- Stable cutaneous Kaposi's Sarcoma that is unlikely to require any form of systemic therapy during the study period.
- Wasting syndrome due to HIV infection if, in the investigator's opinion, it is not actively progressive.
Show all 14Show fewer
- Any active clinically significant disease (e.g. TB, cardiac dysfunction) or findings during screening of medical history or physical examination that in the investigator's opinion, would compromise the outcome of the study.
- Pregnant or breast-feeding female.
- Renal impairment: serum creatinine > 2 x ULN.
- Chronic Hepatitis B or C with ALT or AST > 3 x ULN.
- Acute Hepatitis A, B or C. Acute Hepatitis A, B or C.
- Any grade 3 or 4 toxicity according to the enhanced ACTG grading severity list, except for grade 3 or 4 asymptomatic triglyceride/cholesterol elevations, isolated grade 3 increased in GGT, grade 3 increases in glucose, asymptomatic grade 3 increases in amylase with no elevation of lipase.
- Currently significant diarrhea, gastric stasis or constipation that in the investigator's opinion could influence drug absorption or bioavailability.
- Subjects with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (INR > 1.3 or albumin < 30g/l or bilirubin > 2.5 x ULN).
Trial locations and contacts
1 site in 1 country.
Jose Luis Blanco, MD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic
Barcelona, Barcelona, 08036
Jose Luis Blanco, MD
About this study
Official title: Integrase Resistance Analysis in Treated Experienced HIV Patients Who Interrupted Raltegravir Due to Incomplete Viral Suppression
Prospective study to evaluate the potential persistent viral effect of raltegravir in 20 treatment experienced HIV patients with incomplete viral suppression
- Conditions
- HIV Infection
- Being tested
- resume raltegravir
- Keywords
- HIV, resistance, integrase
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resume raltegravirDrug
resume raltegravir after 16 weeks of stopping
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in viral load after resuming raltegravir in patients with incomplete viral suppression with raltegravir.
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 posted10 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJan 2010 (estimated)
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies 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 N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Investigators
- Jose M Gatell, MD, Study chair, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787774
- Sponsor's protocol ID
- RAL-dyn
- Acronym
- RAL-dyn
- Status last verified
- Mar 2010
- First submitted
- 7 Nov 2008
- Last updated
- 31 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrase Resistance Analysis in Treated Experienced HIV Patients Who Interrupted Raltegravir Due to Incomplete Viral Suppression
- ClinicalTrials.gov ID
- NCT00787774
- Acronym / sponsor ID
- RAL-dyn / RAL-dyn
- Conditions
- HIV Infection
- Keywords
- HIV, resistance, integrase
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 10 Nov 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.
Prospective study to evaluate the potential persistent viral effect of raltegravir in 20 treatment experienced HIV patients with incomplete viral suppression
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects on Raltegravir-containing regimen with confirmed virological failure (VL >500c/mL for > 3 months).
- Patients treated with a raltegravir-containing regimen for at least for 24 weeks.
- CD4 cell count > 50 cell/mm3.
- Adherence >90%, measured by short -self report questionnaire during the 3 months preceding the study entry.
- No reasonable additional therapeutic options
Key exclusion criteria (14 listed)
- History or suspicion of alcohol or drug use which in the investigator's opinion would likely compromise subjects' safety and/or study procedures.
- A positive urine drug test for amphetamines, cocaine and opioids at two consecutive screenings (a positive drug test at study screening will be repeated at baseline).
- Life expectancy less than 6 months.
- Subject has any currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection 1993) with the following 2 exceptions:
- Any active clinically significant disease (e.g. TB, cardiac dysfunction) or findings during screening of medical history or physical examination that in the investigator's opinion, would compromise the outcome of the study.
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 |
|---|---|---|
| resume raltegravirresume raltegravir after 16 weeks of stopping | Drug | – |
Primary outcome
Change in viral load after resuming raltegravir in patients with incomplete viral suppression with raltegravir.
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2010.
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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.
Jose Luis Blanco, MD contact
Jose M Gatell, MD study chair
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 study testing resume raltegravir in people with HIV Infection, 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 5 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 31 Mar 2010. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jose Luis Blanco, MD (+34932275400 ext. 3311), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in viral load after resuming raltegravir in patients with incomplete viral suppression with raltegravir. (time frame: 24 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 31 Mar 2010.