HIV InfectionsNVP+3TCNCT03223402
Nevirapine + 3TC Based Maintenance Therapy for HIV Infection
A study testing Nevirapine plus lamivudine in people with HIV Infections, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial summary
Type of study: Investigator initiated clinical study Study design: One arm, open label, pilot study (n=10) Research question Is treatment with Nevirapine + 3TC sufficient for HIV maintenance Risk Category B (no investigational drugs, non standard Tx) Therapies with 2 drugs are often done in HIV-maintenance. 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?
- Nevirapine plus lamivudine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Dec 2016to 31 May 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-pos, 18 years
- Stable ART, Nevirapine based (plus 2 nukleotide-analogues), at least 6 months
- Viral load suppression at least 24 months Prior to inclusion (<50cp/ml)
Who cannot join
- chronic Hepatitis B necessitating tenofovir therapy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007
About this study
Official title: NEVIRAPINE Plus LAMIVUDINE (3TC) for HIV Maintenance Therapy - A Single Center Pilot Study
Type of study: Investigator initiated clinical study Study design: One arm, open label, pilot study (n=10) Research question Is treatment with Nevirapine + 3TC sufficient for HIV maintenance Risk Category B (no investigational drugs, non standard Tx) Therapies with 2 drugs are often done in HIV-maintenance. This is a systematical evaluation of such a two drug trial. Rescue therapy is well defined within the protocol. Centers (n) St. Gallen only Participants 10 HIV Patients already on nevirapine + 2 non-nuke RT-Inhibitors Study duration 24 weeks primary observation period after study termination, patients may opt to continue on the bi-therapy. Clinical follow up will then continue Sponsor/Investigator Pietro Vernazza, Kantonsspital St. Gallen Principal investigator Pietro Vernazza, MD. Kantonsspital St. Gallen Co-Investigators Patrick Schmid, MD, Matthias Hoffmann, MD
Financial source None (Pilot Study) If study demonstrates good results, an SNF grant proposal will be submitted
Read the detailed description
This is a pilot study to evaluate the efficacy of a two drug combination for Long term HIV maintenance therapy.
The study is conducted in order to confirm the feasibility of the combination of Nevirapine and lamivudine (3TC) in patients with long term fully suppressive therapy.
Patients (n=10) with a stable (>6 months) Nevirapine based triple therapy and a full viral load suppression for at least 2 years will continue their therapy for 6 months with Nevirapine+3TC.
The primary endpoint is treatment failure defined as an HIV-RNA value >100 cp/ml, confirmed by a second measurement.
Preliminary stopping rules are defined if results indicate futility. Futility is defined as a situation, where the investigators would stop their plan to conduct a multicenter comparative trial. Futility is reached, when the study documents more than 1 failure in the first 5 patients over 24 weeks of observation or more than 2 failures in all 10 patients.
Only 10 patients will be followed in this single center pilot study.
After an amendement (April 2017) the total number of 20 patients was increased to 20. Futility was defined as more than 2 failures in 20 patients.
- Conditions
- HIV Infections
- Being tested
- Nevirapine plus lamivudine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nevirapine plus lamivudineOther
In this Pilot study, the efficacy of a bi-therapy consisting of NVP+3TC instead of NVP+2NRTI should be evaluated before a large multicenter study evaluating this combination is started.
| Study group | Role | What they receive |
|---|---|---|
| nevirapine plus lamivudine | Experimental | patients from one Center switching from a Nevirapine based Regimen on Nevirapine + 3TC Receives: Other: Nevirapine plus lamivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure defined as HIV-RNA > 100 cp/ml
Patients reaching a viral load measurement >100cp /ml (confirmed) within the first 24 weeks of therapy with monthly HIV-RNA testing.
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 posted21 Jul 2017
- Study start23 Dec 2016
- Primary completion15 May 2018
- Study completion31 May 2018
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study, one arm. We do not evaluate a specific drug. It is an Evaluation of a combination with just two instead of three drugs for the Treatment of HIV
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, pietro vernazza, Cantonal Hospital of St. Gallen
- Investigators
- Pietro L Vernazza, MD, Principal investigator, KSSG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223402
- Sponsor's protocol ID
- BASEC Nr. 2016-01963
- Acronym
- NVP+3TC
- Status last verified
- Jul 2018
- First submitted
- 15 Dec 2016
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: not planned
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEVIRAPINE Plus LAMIVUDINE (3TC) for HIV Maintenance Therapy - A Single Center Pilot Study
- ClinicalTrials.gov ID
- NCT03223402
- Acronym / sponsor ID
- NVP+3TC / BASEC Nr. 2016-01963
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- 23 Dec 2016 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 21 Jul 2017 (actual)
- 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.
Type of study: Investigator initiated clinical study Study design: One arm, open label, pilot study (n=10) Research question Is treatment with Nevirapine + 3TC sufficient for HIV maintenance Risk Category B (no investigational drugs, non standard Tx) Therapies with 2 drugs are often done in HIV-maintenance. This is a systematical evaluation of such a two drug trial. Rescue therapy is well defined within the protocol. Centers (n) St. Gallen only Participants 10 HIV Patients already on nevirapine + 2 non-nuke RT-Inhibitors Study duration 24 weeks primary observation period after study termination, patients may opt to continue on the bi-therapy. Clinical follow up will then continue Sponsor/Investigator Pietro Vernazza, Kantonsspital St. Gallen Principal investigator Pietro Vernazza, MD. Kantonsspital St. Gallen Co-Investigators Patrick Schmid, MD, Matthias Hoffmann, MD
Financial source None (Pilot Study) If study demonstrates good results, an SNF grant proposal will be submitted
Detailed description
This is a pilot study to evaluate the efficacy of a two drug combination for Long term HIV maintenance therapy.
The study is conducted in order to confirm the feasibility of the combination of Nevirapine and lamivudine (3TC) in patients with long term fully suppressive therapy.
Patients (n=10) with a stable (>6 months) Nevirapine based triple therapy and a full viral load suppression for at least 2 years will continue their therapy for 6 months with Nevirapine+3TC.
The primary endpoint is treatment failure defined as an HIV-RNA value >100 cp/ml, confirmed by a second measurement.
Preliminary stopping rules are defined if results indicate futility. Futility is defined as a situation, where the investigators would stop their plan to conduct a multicenter comparative trial. Futility is reached, when the study documents more than 1 failure in the first 5 patients over 24 weeks of observation or more than 2 failures in all 10 patients.
Only 10 patients will be followed in this single center pilot study.
After an amendement (April 2017) the total number of 20 patients was increased to 20. Futility was defined as more than 2 failures in 20 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study, one arm. We do not evaluate a specific drug. It is an Evaluation of a combination with just two instead of three drugs for the Treatment of HIV
| Arm | Type | Receives |
|---|---|---|
| nevirapine plus lamivudine | Experimental | Other: Nevirapine plus lamivudinepatients from one Center switching from a Nevirapine based Regimen on Nevirapine + 3TC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HIV-pos, 18 years
- Stable ART, Nevirapine based (plus 2 nukleotide-analogues), at least 6 months
- Viral load suppression at least 24 months Prior to inclusion (<50cp/ml)
Key exclusion criteria (1 listed)
- chronic Hepatitis B necessitating tenofovir therapy
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 |
|---|---|---|
| Nevirapine plus lamivudineIn this Pilot study, the efficacy of a bi-therapy consisting of NVP+3TC instead of NVP+2NRTI should be evaluated before a large multicenter study evaluating this combination is started. | Other | nevirapine plus lamivudine |
Primary outcome
Treatment failure defined as HIV-RNA > 100 cp/ml
Time frame: 24 weeks
Patients reaching a viral load measurement >100cp /ml (confirmed) within the first 24 weeks of therapy with monthly HIV-RNA testing.
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 18 Jul 2018.
- Individual participant dataSharing planned: No. not planned
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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.
Pietro L Vernazza, MD principal investigator
KSSG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nevirapine plus lamivudine in people with HIV Infections, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
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 3 inclusion and 1 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 18 Jul 2018. 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 Switzerland. 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?
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?
Treatment failure defined as HIV-RNA > 100 cp/ml (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 18 Jul 2018.