HIV InfectionsNCT01204905
R5 Integrase Study in HIV-1 Naive Patients
A study testing Raltegravir and Maraviroc in combination in people with HIV Infections, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This is a pilot, open-label study of raltegravir and maraviroc in combination for the treatment of antiretroviral naïve patients. The study will enroll 7 antiretroviral naïve patients with CD4 counts ≥ 350 and viral loads > 5,000. The subjects will be followed for 48 weeks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Raltegravir and Maraviroc in combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to 16 May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 infection
- CD4 count ≥ 350
- RNA > 5,000
- CCR5 tropic virus
- Baseline genotype without significant mutations known to confer antiretroviral drug resistance to currently licensed antiretroviral agents
- Antiretroviral naïve (< 7 days of experience)
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- 18-75 years of age
- Subject able to provide informed consent for the study
- Women of child-bearing age agree to remain abstinent or use (or have their partner use) an acceptable method of birth control throughout the study. Acceptable method of birth control is defined as intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy.
Who cannot join
- Dual/mixed tropic virus,
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times the upper limits of normal;
- Total bilirubin >1.5 mg/dL,
- Women pregnant or breastfeeding,
- History of malignancy
- Enrollment in an experimental protocol with concomitant use of drugs known to impact or be impacted in terms of pk or drug-drug interactions with either raltegravir or maraviroc. This includes inducers of UGT1A1 ( such as rifampin, phenytoin, Phenobarbital rifabutin, St. John's wart) as well as CYP3A inhibitors (such as ketoconazole, itraconazole, clarithromycin , nefazodone and telithromycin) and CYP3A inducers (such as rifampin, carbamazepine, Phenobarbital and phenytoin)
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- Enrollment in an experimental protocol having received investigational agents(antiretroviral or non-antiretroviral) within 30 days of study enrollment
- Chronic active hepatitis B infection
- Subject has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study, such that it is not in the best interest of the patient to participate.
- Subject is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
- Subject requires or is anticipated to require any of the prohibited medications noted in the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Institute of Human Virology
Baltimore, Maryland, 21201
About this study
Official title: Raltegravir and Maraviroc in Combination for the Treatment of Antiretroviral Naïve HIV-1 Infected Patients
This is a pilot, open-label study of raltegravir and maraviroc in combination for the treatment of antiretroviral naïve patients. The study will enroll 7 antiretroviral naïve patients with CD4 counts ≥ 350 and viral loads > 5,000. The subjects will be followed for 48 weeks. The combination of these two agents has the potential to be a potent regimen with minimal metabolic complications. However, they have not been studied in combination previously.
This pilot study proposes to evaluate this combination in antiretroviral naïve patients to document the safety and efficacy of this combination in order to provide clinicians with a treatment regimen that minimizes the risk of metabolic complications.
Read the detailed description
Seven antiretroviral naïve HIV infected participants will be treated with a combination of raltegravir and maraviroc and followed for 48 weeks to determine the time to virologic suppression of (HIV-1 viral load < 50 copies/ml).
- Conditions
- HIV Infections
- Being tested
- Raltegravir and Maraviroc in combination
- Keywords
- HIV-1, CD4, Viral Load, Human Immunodeficiency Virus (HIV)
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raltegravir and Maraviroc in combinationDrug
Also called Raltegravir (Isentress), Maraviroc(Selzentry)
Raltegravir 400 mg tablet twice a day, ~12 hours (10 to 14 hours) apart
Maraviroc 300 mg tablet twice a day, ~12 hours (10 to 14 hours) apart
| Study group | Role | What they receive |
|---|---|---|
| Open Label ART | Experimental | Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks. Receives: Drug: Raltegravir and Maraviroc in combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Load
Percentage of subjects with HIV-1 viral load < 50 copies/ml
Measured: 48 weeks
Secondary outcomes (1)
Viral Suppression
Time to attainment of virologic suppression
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startSep 2010
- Primary completion16 May 2014
- Study completion16 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm treatment study
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Robert R. Redfield, MD, Principal investigator, University of Maryland, Institute of Human Virology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204905
- Sponsor's protocol ID
- HP-00045769
- Status last verified
- Nov 2022
- First submitted
- 16 Sep 2010
- Last updated
- 14 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Raltegravir and Maraviroc in Combination for the Treatment of Antiretroviral Naïve HIV-1 Infected Patients
- ClinicalTrials.gov ID
- NCT01204905
- Acronym / sponsor ID
- HP-00045769
- Conditions
- HIV Infections
- Keywords
- HIV-1, CD4, Viral Load, Human Immunodeficiency Virus (HIV)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Sep 2010
- Primary completion
- 16 May 2014 (actual)
- Study completion
- 16 May 2014 (actual)
- First posted
- 17 Sep 2010 (estimated)
- Results
- Posted 18 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot, open-label study of raltegravir and maraviroc in combination for the treatment of antiretroviral naïve patients. The study will enroll 7 antiretroviral naïve patients with CD4 counts ≥ 350 and viral loads > 5,000. The subjects will be followed for 48 weeks. The combination of these two agents has the potential to be a potent regimen with minimal metabolic complications. However, they have not been studied in combination previously.
This pilot study proposes to evaluate this combination in antiretroviral naïve patients to document the safety and efficacy of this combination in order to provide clinicians with a treatment regimen that minimizes the risk of metabolic complications.
Detailed description
Seven antiretroviral naïve HIV infected participants will be treated with a combination of raltegravir and maraviroc and followed for 48 weeks to determine the time to virologic suppression of (HIV-1 viral load < 50 copies/ml).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm treatment study
| Arm | Type | Receives |
|---|---|---|
| Open Label ART | Experimental | Drug: Raltegravir and Maraviroc in combinationPatients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- HIV-1 infection
- CD4 count ≥ 350
- RNA > 5,000
- CCR5 tropic virus
- Baseline genotype without significant mutations known to confer antiretroviral drug resistance to currently licensed antiretroviral agents
Key exclusion criteria (11 listed)
- Dual/mixed tropic virus,
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times the upper limits of normal;
- Total bilirubin >1.5 mg/dL,
- Women pregnant or breastfeeding,
- History of malignancy
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 |
|---|---|---|
| Raltegravir and Maraviroc in combinationAlso: Raltegravir (Isentress), Maraviroc(Selzentry)Raltegravir 400 mg tablet twice a day, ~12 hours (10 to 14 hours) apart Maraviroc 300 mg tablet twice a day, ~12 hours (10 to 14 hours) apart | Drug | Open Label ART |
Primary outcome
Viral Load
Time frame: 48 weeks
Percentage of subjects with HIV-1 viral load < 50 copies/ml
1 secondary outcome
Viral Suppression
Time frame: 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Robert R. Redfield, MD principal investigator
University of Maryland, Institute of Human Virology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Raltegravir and Maraviroc in combination in people with HIV Infections, run by University of Maryland, Baltimore 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 9 inclusion and 11 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 14 Nov 2022. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Viral Load (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 14 Nov 2022.