AIDS/HIV PROBLEMNCT01844310
Raltegravir-based Antiretroviral Therapy for Resistant HIV-1 Infection
A study testing RAL+TDF+LPV/r and 3TC+TDF+LPV/r in people with AIDS/HIV PROBLEM, run by Peking Union Medical College at 1 site in China.
Trial summary
This study is to evaluate the safety and efficacy of RAL-based regimen in treatment-experienced patients with resistant HIV infection Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- AIDS/HIV PROBLEM
- What is being tested?
- RAL+TDF+LPV/r and 3TC+TDF+LPV/r
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- May 2013to Dec 2015
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-65 years
- HIV seropositive and confirmed by western blot
- have taken first line antiretroviral therapy for over one year and have any one of the criteria listed below (viral load of all the patients meeting these criteria should be confirmed at PUMCH laboratory)
- Viral load more than 400 copies/ml
- Viral rebound (confirmed by HIV RNA more than 400 copies/ml after virologic suppression)
- When viral load cannot be monitored, patients experience immunologic failure who meet at least one of the criteria listed below will be enrolled:
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- CD4 count equal to or lower than baseline level with first-line therapy,on two occasions over three months apart
- CD4 count with 50 percentage fall from the on-treatment peak value
- persistent CD4 count levels less than 100 cells/μl after over one-year antiretroviral therapy
Who cannot join
- Previous use of protease inhibitors
- Previous use of integrase inhibitors
- Pregnancy and breastfeeding
- poor compliance and drug interaction,
- opportunistic infections or malignancy at recruitment; or opportunistic infections within three months but still unstable within 14 days prior to recruitment
- HBsAg positive
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- patients with the any of the following test results during screening for inclusion: WBC count<2000/μl, neutrophil count<1000/μl, Hb<9g/dl, platelet count<75000/μl, serum creatinine>1.5 ULN, transaminases or alkaline phosphatase >3 ULN, total bilirubin>2 ULN, serum creatinine kinase>2 ULN
- CCr<60 ml/min
- Current intravenous drug use
- Severe neuropathy or mental disorder
- history of alcohol abuse and unable to withdrawal
- Severe peptic ulcer
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, 100730
Wei Lv, MD, 86-10-69155082, lvweipumch@163.com
Taisheng Li, MD
About this study
Official title: Raltegravir-based Antiretroviral Therapy for Resistant HIV-1 Infection in China
This study is to evaluate the safety and efficacy of RAL-based regimen in treatment-experienced patients with resistant HIV infection
Read the detailed description
In our study, both efficacy and safety of raltegravir(RAL)-based therapy will be assessed. 300 treatment-experienced patients with drug-resistant HIV will be randomized to two arms (2:1). Group A (n=200) will be assigned with RAL-based regimen (RAL+TDF+LPV/r).Group B (n=100) will be assigned with current second-line regimen in China (3TC+TDF+LPV/r). Both virological and immunological profiles and responses at baseline and at week 4, 8, 12, 24, 36, and 48 will be evaluated. This study will be the first large-scale, multicenter, randomized, prospective RAL-based therapy study in China for HIV/AIDs patients. The result will provide proves for further practical antiviral therapy for China or other resource-limiting countries.
- Conditions
- AIDS/HIV PROBLEM
- Being tested
- RAL+TDF+LPV/r, 3TC+TDF+LPV/r
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAL+TDF+LPV/rDrug
Group A will be assigned with RAL-based regimen (RAL+TDF+LPV/r).
3TC+TDF+LPV/rDrug
Group B will be assigned with 3TC+TDF+LPV/r
| Study group | Role | What they receive |
|---|---|---|
| RAL +TDF+ LPV/r | Active comparator | Arm A: RAL +TDF+ KELETRA(LPV/r) Group A will be assigned with RAL+TDF+LPV/r. Receives: Drug: RAL+TDF+LPV/r |
| 3TC+ TDF+LPV/r | Active comparator | Arm B: 3TC+ TDF+KELETRA(LPV/r) Group B will be assigned with 3TC+TDF+LPV/r Receives: Drug: 3TC+TDF+LPV/r |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with HIV-1 RNA < 400 copies/mL at week 48
Measured: 48 weeks
Secondary outcomes (3)
Percentage of participants with HIV-1 RNA < 40 copies/mL at week 48
Measured: 48 weeks
Change from baseline in CD4 count at week 48
Measured: Baseline and 48 weeks
Incidence of adverse events and laboratory abnormalities in the two treatment arms from baseline to week 48
Measured: through week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AIDS/HIV PROBLEMStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI Taisheng, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844310
- Sponsor's protocol ID
- CACT1215-01
- Status last verified
- Apr 2013
- First submitted
- 25 Aug 2012
- Last updated
- 1 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Raltegravir-based Antiretroviral Therapy for Resistant HIV-1 Infection in China
- ClinicalTrials.gov ID
- NCT01844310
- Acronym / sponsor ID
- CACT1215-01
- Conditions
- AIDS/HIV PROBLEM
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 1 May 2013 (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.
This study is to evaluate the safety and efficacy of RAL-based regimen in treatment-experienced patients with resistant HIV infection
Detailed description
In our study, both efficacy and safety of raltegravir(RAL)-based therapy will be assessed. 300 treatment-experienced patients with drug-resistant HIV will be randomized to two arms (2:1). Group A (n=200) will be assigned with RAL-based regimen (RAL+TDF+LPV/r).Group B (n=100) will be assigned with current second-line regimen in China (3TC+TDF+LPV/r). Both virological and immunological profiles and responses at baseline and at week 4, 8, 12, 24, 36, and 48 will be evaluated. This study will be the first large-scale, multicenter, randomized, prospective RAL-based therapy study in China for HIV/AIDs patients. The result will provide proves for further practical antiviral therapy for China or other resource-limiting countries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAL +TDF+ LPV/r | Active comparator | Drug: RAL+TDF+LPV/rArm A: RAL +TDF+ KELETRA(LPV/r) Group A will be assigned with RAL+TDF+LPV/r. |
| 3TC+ TDF+LPV/r | Active comparator | Drug: 3TC+TDF+LPV/rArm B: 3TC+ TDF+KELETRA(LPV/r) Group B will be assigned with 3TC+TDF+LPV/r |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 18-65 years
- HIV seropositive and confirmed by western blot
- have taken first line antiretroviral therapy for over one year and have any one of the criteria listed below (viral load of all the patients meeting these criteria should be confirmed at PUMCH laboratory)
Key exclusion criteria (12 listed)
- Previous use of protease inhibitors
- Previous use of integrase inhibitors
- Pregnancy and breastfeeding
- poor compliance and drug interaction,
- opportunistic infections or malignancy at recruitment; or opportunistic infections within three months but still unstable within 14 days prior to recruitment
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 |
|---|---|---|
| RAL+TDF+LPV/rGroup A will be assigned with RAL-based regimen (RAL+TDF+LPV/r). | Drug | RAL +TDF+ LPV/r |
| 3TC+TDF+LPV/rGroup B will be assigned with 3TC+TDF+LPV/r | Drug | 3TC+ TDF+LPV/r |
Primary outcome
Percentage of participants with HIV-1 RNA < 400 copies/mL at week 48
Time frame: 48 weeks
3 secondary outcomes
Percentage of participants with HIV-1 RNA < 40 copies/mL at week 48
Time frame: 48 weeks
Change from baseline in CD4 count at week 48
Time frame: Baseline and 48 weeks
Incidence of adverse events and laboratory abnormalities in the two treatment arms from baseline to week 48
Time frame: through week 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RAL+TDF+LPV/r and 3TC+TDF+LPV/r in people with AIDS/HIV PROBLEM, run by Peking Union Medical College at 1 site in China.
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 9 inclusion and 12 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 1 May 2013. 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 China. 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 Taisheng Li, MD (86-10-69155086, litsh@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with HIV-1 RNA < 400 copies/mL at week 48 (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 1 May 2013.