Human Immunodeficiency VirusPhase 4UW PIC 330NCT00781287
Raltegravir (Isentress/MK-0518) and HIV-1 Infected CD4 Cells During Acute/Early HIV-1
A Phase 4 study testing 3-drug anti-HIV therapy and Raltegravir in people with Human Immunodeficiency Virus, run by University of Washington at 1 site in United States.
Trial summary
This is an investigator-initiated, two-year, randomized, controlled, single-center, open-label, pilot study comparing 3-drug highly active antiretroviral therapy (HAART) to 3-drug HAART plus raltegravir for persons with acute and early HIV-1 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- 3-drug anti-HIV therapy and Raltegravir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Oct 2013
- 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
- Acute or Early HIV-1 infection
- HIV-1 RNA > or equal to 500 copies/mL
- Acceptable safety lab results (specified in protocol)
- Negative pregnancy test for females
- Willingness to use contraception (for females of reproductive potential
Who cannot join
- Prior receipt of investigational HIV-1 vaccine
- Use of immunomodulators other than systemic steroids within 30 days before entry
- Serious medical or psychiatric illness that would interfere with study participation
- Active drug or alcohol use that would interfere with study participation
- Allergy/hypersensitivity to raltegravir
- Pre- or Post-exposure prophylaxis for the exposure that led to HIV-1 acquisition
- Pregnancy or breastfeeding
- History of malignancy (other than localized squamous cell or basal cell cancer of the skin)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Primary Infection Clinic
Seattle, Washington, 98195
About this study
Official title: Impact of Raltegravir (Isentress/MK-0518) - Containing Regimens on HIV-1 Infected CD4+ T-Cells During Acute and Early HIV-1 Infection: A Randomized, Controlled Study Comparing Standard Antiretroviral Therapy to Standard Therapy Plus Raltegravir
This is an investigator-initiated, two-year, randomized, controlled, single-center, open-label, pilot study comparing 3-drug highly active antiretroviral therapy (HAART) to 3-drug HAART plus raltegravir for persons with acute and early HIV-1 infection. The study will test the hypothesis that use of the integrase inhibitor raltegravir (400 mg BID orally) to inhibit the integration step of the HIV-1 life cycle in conjunction with HAART in subjects with recently acquired HIV-1 infection will decrease the number of HIV-1 infected CD4+ T-cells to a greater extent than a 3-drug HAART regimen.
Read the detailed description
The study will be conducted at the UW Primary Infection Clinic and the UW AIDS Clinical Trials Unit. Secondary objectives will characterize safety, tolerability, plasma HIV-1 RNA and CD4+ T-cell values. The 3-drug HAART will be chosen and provided by the subject.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- 3-drug anti-HIV therapy, Raltegravir
- Keywords
- human immunodeficiency virus, raltegravir, primary HIV infection, HIV-1
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-drug anti-HIV therapyDrug
3 FDA-approved drugs, including two nucleos(t)ide reverse transcriptase inhibitors and either a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor (Low dose ritonavir can be used to enhance the protease inhibitor and is not considered one of the 3 anti-HIV drugs)
RaltegravirDrug
Also called Isentress
400 mg BID PO
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir + 3-drug anti-HIV therapy | Experimental | Not described Receives: Drug: 3-drug anti-HIV therapy; Drug: Raltegravir |
| 3-drug anti-HIV therapy | Active comparator | Not described Receives: Drug: 3-drug anti-HIV therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of HIV-1 infected CD4+ T-cells measured by a quantitative HIV-1 DNA PCR assay
Measured: 96 weeks
Secondary outcomes (5)
CD4+ T-cells
Measured: 96 weeks
Plasma HIV-1 RNA
Measured: 96 weeks
Grade 3 and 4 signs and symptoms or laboratory toxicities at least one grade higher than baseline
Measured: From study drug start to 8 weeks after drug discontinuation
Plasma HIV-1 RNA
Measured: Baseline to Week 8
Tolerability (Discontinuation of raltegravir)
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2008 (estimated)
- Study startFeb 2009
- Primary completionFeb 2012
- Study completionOct 2013 (estimated)
Why it stopped: Enrollment too slow.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Ann Collier, University of Washington
- Investigators
- Ann C. Collier, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781287
- Sponsor's protocol ID
- 34908-D
- Acronym
- UW PIC 330
- Status last verified
- Aug 2013
- First submitted
- 24 Oct 2008
- Last updated
- 12 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Raltegravir (Isentress/MK-0518) - Containing Regimens on HIV-1 Infected CD4+ T-Cells During Acute and Early HIV-1 Infection: A Randomized, Controlled Study Comparing Standard Antiretroviral Therapy to Standard Therapy Plus Raltegravir
- ClinicalTrials.gov ID
- NCT00781287
- Acronym / sponsor ID
- UW PIC 330 / 34908-D
- Conditions
- Human Immunodeficiency Virus
- Keywords
- human immunodeficiency virus, raltegravir, primary HIV infection, HIV-1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment too slow.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Feb 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Oct 2013 (estimated)
- First posted
- 28 Oct 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.
This is an investigator-initiated, two-year, randomized, controlled, single-center, open-label, pilot study comparing 3-drug highly active antiretroviral therapy (HAART) to 3-drug HAART plus raltegravir for persons with acute and early HIV-1 infection. The study will test the hypothesis that use of the integrase inhibitor raltegravir (400 mg BID orally) to inhibit the integration step of the HIV-1 life cycle in conjunction with HAART in subjects with recently acquired HIV-1 infection will decrease the number of HIV-1 infected CD4+ T-cells to a greater extent than a 3-drug HAART regimen.
Detailed description
The study will be conducted at the UW Primary Infection Clinic and the UW AIDS Clinical Trials Unit. Secondary objectives will characterize safety, tolerability, plasma HIV-1 RNA and CD4+ T-cell values. The 3-drug HAART will be chosen and provided by the subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raltegravir + 3-drug anti-HIV therapy | Experimental | Drug: 3-drug anti-HIV therapy, Drug: Raltegravir |
| 3-drug anti-HIV therapy | Active comparator | Drug: 3-drug anti-HIV therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Acute or Early HIV-1 infection
- HIV-1 RNA > or equal to 500 copies/mL
- Acceptable safety lab results (specified in protocol)
- Negative pregnancy test for females
- Willingness to use contraception (for females of reproductive potential
Key exclusion criteria (8 listed)
- Prior receipt of investigational HIV-1 vaccine
- Use of immunomodulators other than systemic steroids within 30 days before entry
- Serious medical or psychiatric illness that would interfere with study participation
- Active drug or alcohol use that would interfere with study participation
- Allergy/hypersensitivity to raltegravir
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 |
|---|---|---|
| 3-drug anti-HIV therapy3 FDA-approved drugs, including two nucleos(t)ide reverse transcriptase inhibitors and either a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor (Low dose ritonavir can be used to enhance the protease inhibitor and is not considered one of the 3 anti-HIV drugs) | Drug | 3-drug anti-HIV therapy, Raltegravir + 3-drug anti-HIV therapy |
| RaltegravirAlso: Isentress400 mg BID PO | Drug | Raltegravir + 3-drug anti-HIV therapy |
Primary outcome
Number of HIV-1 infected CD4+ T-cells measured by a quantitative HIV-1 DNA PCR assay
Time frame: 96 weeks
5 secondary outcomes
CD4+ T-cells
Time frame: 96 weeks
Plasma HIV-1 RNA
Time frame: 96 weeks
Grade 3 and 4 signs and symptoms or laboratory toxicities at least one grade higher than baseline
Time frame: From study drug start to 8 weeks after drug discontinuation
Plasma HIV-1 RNA
Time frame: Baseline to Week 8
Tolerability (Discontinuation of raltegravir)
Time frame: 96 weeks
Results and safety
The study was stopped early (reason given: Enrollment too slow.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 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.
Ann C. Collier, MD principal investigator
University of Washington
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 3-drug anti-HIV therapy and Raltegravir in people with Human Immunodeficiency Virus, run by University of Washington at 1 site in United States.
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 8 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 12 Aug 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 United States. 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: Enrollment too slow.). 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?
Number of HIV-1 infected CD4+ T-cells measured by a quantitative HIV-1 DNA PCR assay (time frame: 96 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 12 Aug 2013.