HIV-1 InfectionsPhase 2NCT00830804
Safety and Effectiveness of Raltegravir Plus Darunavir/Ritonavir in Treatment-Naive HIV-Infected Adults
A Phase 2 study testing Raltegravir and Darunavir/Ritonavir in people with HIV-1 Infections, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 22 sites in United States.
Trial summary
The purpose of this study is to assess the effectiveness and safety of an antiretroviral therapy (ART) regimen consisting of raltegravir (RAL) and darunavir (DRV)/ritonavir (RTV) as first-line therapy in treatment-naïve participants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1 Infections
- What is being tested?
- Raltegravir and Darunavir/Ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 22 sitesUnited States
- Study dates
- Apr 2009to Sep 2010
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1-infected
- Plasma HIV-1 RNA of at least 5,000 copies/mL within 90 days prior to study entry
- HIV genotype (for reverse transcriptase and protease) performed at any time prior to study entry. More information on this criterion can be found in the protocol.
- ARV drug-naive. More information on this criterion can be found in the protocol.
- Negative result from a hepatitis B surface antigen test performed within 90 days prior to study entry
- Agree to use one form of medically-accepted contraceptive throughout the study and for 60 days after stopping study treatment. More information on this criterion can be found in the protocol.
Who cannot join
- Serious illness requiring systemic treatment and/or hospitalization for at least 7 days prior to study. More information on this criterion can be found in the protocol.
- Screening HIV genotype obtained any time prior to study entry with more than one DRV resistance-associated mutation [RAM] (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, I84V, and L89V) or L76V alone
- Known major integrase inhibitor RAM(s), including N155H, Q148H/R/K, Y143C/R, and G140S
- Severe renal insufficiency requiring hemodialysis or peritoneal dialysis
- Treatment with immunomodulators within 30 days prior to study entry. More information on this criterion can be found in the protocol.
- Current medications that are prohibited with any study medications. More information on this criterion can be found in the protocol.
Show all 10Show fewer
- Known allergy/sensitivity to study drugs or their formulations. A history of sulfa allergy is not an exclusion.
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with the study.
- Certain abnormal laboratory results. More information on this criterion can be found in the protocol.
- Pregnant or breastfeeding
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
University of Colorado Hospital CRS
Aurora, Colorado, 80045
AlabamaTherapeutics CRS
Birmingham, Alabama, 35294
Beth Israel Deaconess Med Center
Boston, Massachusetts, 02115
Brigham and Women's Hosp. ACTG CRS
Boston, Massachusetts, 02115
Unc Aids Crs
Chapel Hill, North Carolina, 27599
Northwestern University CRS
Chicago, Illinois, 60611
Univ. of Cincinnati CRS
Cincinnati, Ohio, 45267-0405
Case CRS
Cleveland, Ohio, 44106
MetroHealth CRS
Cleveland, Ohio, 44109
The Ohio State Univ. AIDS CRS
Columbus, Ohio, 43210
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, 27710
Houston AIDS Research Team
Houston, Texas, 77030
Vanderbilt Therapeutics CRS
Nashville, Tennessee, 37203
Stanford CRS
Palo Alto, California, 94304
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104
University of Pittsburgh CTU
Pittsburgh, Pennsylvania, 15213
The Miriam Hospital
Providence, Rhode Island, 02906
AIDS Community Health Ctr. ACTG CRS
Rochester, New York, 14604
Ucsd, Avrc Crs
San Diego, California, 92103
Ucsf Aids Crs
San Francisco, California, 94110
Washington U CRS
St Louis, Missouri, 63110
Georgetown University CRS
Washington D.C., District of Columbia, 20007
About this study
Official title: A Pilot Efficacy and Safety Trial of Raltegravir Plus Darunavir/Ritonavir for Treatment-Naive HIV-1-Infected Subjects
The purpose of this study is to assess the effectiveness and safety of an antiretroviral therapy (ART) regimen consisting of raltegravir (RAL) and darunavir (DRV)/ritonavir (RTV) as first-line therapy in treatment-naïve participants.
Read the detailed description
Despite the remarkable strides made in the treatment of HIV-1-infected persons over the last decade, current first-line ART regimens are imperfect. The ideal combination, unlike some current first-line options, would have uncompromised efficacy in the presence of transmitted drug-resistant variants. The primary purpose of this study is to estimate the cumulative proportion of ART-naive participants experiencing virologic failure at or prior to week 24 after initiating raltegravir (RAL) plus darunavir/ritonavir (DRV/RTV).
The study will last 52 weeks. All participants will follow the same treatment schedule and take RAL plus DRV/RTV orally daily for the duration of the trial.
After entry, all participants will have scheduled visits at weeks 1, 4, 12, 24, 36, 48, and 52. Medical/medication history, blood and urine collection, and liver function tests will occur at screening. A targeted physical exam and concomitant medications history will occur at all study visits. Blood and urine collection and liver function tests will occur at most study visits. For females, a pregnancy test will occur at screening and study entry.
RAL and DRV were provided by the study. RTV was not provided by the study.
- Conditions
- HIV-1 Infections
- Being tested
- Raltegravir, Darunavir/Ritonavir
- Keywords
- Treatment Naive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaltegravirDrug
Also called RAL
400 mg tablet taken orally twice daily
Darunavir/RitonavirDrug
Also called DRV/RTV
800 mg Darunavir/100 mg Ritonavir tablet taken orally once daily
| Study group | Role | What they receive |
|---|---|---|
| RAL + DRV/RTV | Experimental | Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks Receives: Drug: Raltegravir; Drug: Darunavir/Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Virologic Failure After Initiating RAL Plus DRV/RTV at or Prior to Week 24
Virologic failure is defined as: at week 12, confirmed plasma HIV-1 RNA >= 1000 copies/ml or confirmed rebound from the week 4 value by >0.5 log10 copies/ml (for subjects with week 4 value <= 50 copies/ml, confirmed rebound to >50 copies/ml); at week 24 or later, confirmed value > 50 copies/ml. Viral load confirmation was scheduled 7-35 days after initial virologic failure. The proportion was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.
Measured: From start of study treatment to week 24
Secondary outcomes (16)
Proportion of Participants With Virologic Failure or Off Study Treatment Regimen or Death at or Prior to Week 24
The proportion of participants with virologic failure (see primary outcome measure for definition) and/or premature treatment discontinuation/modification and/or death was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.
Measured: From start of study treatment to Week 24
Change in Plasma HIV-1 RNA From Baseline to Week 1
Results report the week 1 change from baseline (week 1 - baseline) in HIV-1 RNA. Baseline HIV-1 RNA was computed as the mean of the log10 HIV-1 RNA values at pre-entry and study entry.
Measured: Baseline and week 1
Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/ml or <200 Copies/ml at Week 24
Results report the percentage of participants with plasma HIV-1 RNA < 50 copies/ml or <200 copies/ml at week 24.
Measured: From start of study treatment to week 24
Proportion of Participants With Plasma HIV-1 RNA <50 Copies/ml or <200 Copies/ml at Week 48
Results report the percentage of participants with plasma HIV-1 RNA <50 copies/ml or <200 copies/ml at week 48.
Measured: From start of study treatment to week 48
Proportion of Participants Who Experienced Signs/Symptoms or Laboratory Toxicities Grade 3 or Higher, or of Any Grade Which Led to a Permanent Change or Discontinuation of Study Treatment
Signs, symptoms and laboratory values were graded according to the Division of AIDS Adverse Event Grading System. Results report the percentage of participants who had grade 3 or higher events, or events of any grade which led to a permanent change or discontinuation of study treatment, which occurred any time from start of treatment to end of treatment.
Measured: From start of study treatment to week 52
Number of Participants With Pretreatment Drug Resistance
Results report the number of participants who had resistance to non-nucleoside reverse transciptase inhibitors (NNRTI), nucleoside reverse transciptase inhibitors (NRTI) and protease inbitors (PI) based on genotypic resistance testing done prior to participant's entry into the study. Participants are classified into one (and only one category) based on the maximum number of drug class resistance seen for the participant.
Measured: At screening
Number of Participants With Integrase Drug Resistance at Virologic Failure
Results report the number of participants who had integrase resistance mutation(s) detected at the time of virologic failure.
Measured: From 12 weeks after starting study treatment to week 52
Number of Participants With Protease Drug Resistance at Virologic Failure
Results report the number of participants who had protease resistance mutation(s) detected at the time of virologic failure.
Measured: From 12 weeks after starting study treatment to week 52
Number of Participants With Perfect Overall Adherence by Self Report
At each study visit, adherence was measured in terms of the number of missed doses each participant had over a 4-day recall for each drug. Adherence for all study visit weeks were combined for an overall measure of adherence. Participants who had zero missed doses on all weeks in all drugs while on study were classified as having an overall "perfect" adherence.
Measured: From one week after starting study treatment to week 52
Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 24
Results report the week 24 change from week 0 (week 24 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride.
Measured: From start of study treatment through week 24
Change in Fasting Low-density Lipoprotein at Week 24
Results report the week 24 change from week 0 (week 24 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride.
Measured: From start of study treatment through week 24
Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 48
Results report the week 48 change from week 0 (week 48 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride.
Measured: From start of study treatment through week 48
Change in Fasting Low-density Lipoprotein at Week 48
Results report the week 48 change from week 0 (week 48 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride.
Measured: From start of study treatment through week 48
Change in CD4 Count at Week 48
Results report the week 48 change from baseline (week 48 - baseline) in CD4 count. Baseline CD4 count was computed as the mean of CD4 count values at pre-entry and study entry.
Measured: From start of study treatment through week 48
Plasma Trough Concentration of Raltegravir
Plasma trough concentrations (ng/ml) of Raltegravir (RAL) below the detection limit (10 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 9-15 hours after the last RAL dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation.
Measured: From start of study treatment to week 52
Plasma Trough Concentration of Darunavir
Plasma trough concentrations (ng/ml) of Darunavir (DRV) below the detection limit (50 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 20-28 hours after the last DRV dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation.
Measured: From start of study treatment to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startApr 2009
- Primary completionFeb 2010
- Study completionSep 2010
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV-1 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Joseph J. Eron, Jr., MD, Study chair, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830804
- Sponsor's protocol ID
- ACTG A5262
- Other IDs
- 1U01AI068636
- Status last verified
- Oct 2018
- First submitted
- 26 Jan 2009
- Last updated
- 8 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Capetti AF, Piconi S, Landonio S, Rizzardini G, Perno CF. Is dual therapy with raltegravir and protease inhibitors a feasible option in rescue strategy in HIV-1 infection? J Acquir Immune Defic Syndr. 2009 Feb 1;50(2):233-4. doi: 10.1097/QAI.0b013e31818c7e8e. No abstract available.
PubMed 19155770Long MC, King JR, Acosta EP. Pharmacologic aspects of new antiretroviral drugs. Curr HIV/AIDS Rep. 2009 Feb;6(1):43-50. doi: 10.1007/s11904-009-0007-y.
PubMed 19149996Vermeir M, Lachau-Durand S, Mannens G, Cuyckens F, van Hoof B, Raoof A. Absorption, metabolism, and excretion of darunavir, a new protease inhibitor, administered alone and with low-dose ritonavir in healthy subjects. Drug Metab Dispos. 2009 Apr;37(4):809-20. doi: 10.1124/dmd.108.024109. Epub 2009 Jan 8.
PubMed 19131522Taiwo B, Zheng L, Gallien S, Matining RM, Kuritzkes DR, Wilson CC, Berzins BI, Acosta EP, Bastow B, Kim PS, Eron JJ Jr; ACTG A5262 Team. Efficacy of a nucleoside-sparing regimen of darunavir/ritonavir plus raltegravir in treatment-naive HIV-1-infected patients (ACTG A5262). AIDS. 2011 Nov 13;25(17):2113-22. doi: 10.1097/QAD.0b013e32834bbaa9.
PubMed 21857490
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Efficacy and Safety Trial of Raltegravir Plus Darunavir/Ritonavir for Treatment-Naive HIV-1-Infected Subjects
- ClinicalTrials.gov ID
- NCT00830804
- Acronym / sponsor ID
- ACTG A5262
- Conditions
- HIV-1 Infections
- Keywords
- Treatment Naive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Apr 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 28 Jan 2009 (estimated)
- Results
- Posted 10 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effectiveness and safety of an antiretroviral therapy (ART) regimen consisting of raltegravir (RAL) and darunavir (DRV)/ritonavir (RTV) as first-line therapy in treatment-naïve participants.
Detailed description
Despite the remarkable strides made in the treatment of HIV-1-infected persons over the last decade, current first-line ART regimens are imperfect. The ideal combination, unlike some current first-line options, would have uncompromised efficacy in the presence of transmitted drug-resistant variants. The primary purpose of this study is to estimate the cumulative proportion of ART-naive participants experiencing virologic failure at or prior to week 24 after initiating raltegravir (RAL) plus darunavir/ritonavir (DRV/RTV).
The study will last 52 weeks. All participants will follow the same treatment schedule and take RAL plus DRV/RTV orally daily for the duration of the trial.
After entry, all participants will have scheduled visits at weeks 1, 4, 12, 24, 36, 48, and 52. Medical/medication history, blood and urine collection, and liver function tests will occur at screening. A targeted physical exam and concomitant medications history will occur at all study visits. Blood and urine collection and liver function tests will occur at most study visits. For females, a pregnancy test will occur at screening and study entry.
RAL and DRV were provided by the study. RTV was not provided by the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAL + DRV/RTV | Experimental | Drug: Raltegravir, Drug: Darunavir/RitonavirRaltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HIV-1-infected
- Plasma HIV-1 RNA of at least 5,000 copies/mL within 90 days prior to study entry
- HIV genotype (for reverse transcriptase and protease) performed at any time prior to study entry. More information on this criterion can be found in the protocol.
- ARV drug-naive. More information on this criterion can be found in the protocol.
- Negative result from a hepatitis B surface antigen test performed within 90 days prior to study entry
Key exclusion criteria (10 listed)
- Serious illness requiring systemic treatment and/or hospitalization for at least 7 days prior to study. More information on this criterion can be found in the protocol.
- Screening HIV genotype obtained any time prior to study entry with more than one DRV resistance-associated mutation [RAM] (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, I84V, and L89V) or L76V alone
- Known major integrase inhibitor RAM(s), including N155H, Q148H/R/K, Y143C/R, and G140S
- Severe renal insufficiency requiring hemodialysis or peritoneal dialysis
- Treatment with immunomodulators within 30 days prior to study entry. More information on this criterion can be found in the protocol.
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 |
|---|---|---|
| RaltegravirAlso: RAL400 mg tablet taken orally twice daily | Drug | RAL + DRV/RTV |
| Darunavir/RitonavirAlso: DRV/RTV800 mg Darunavir/100 mg Ritonavir tablet taken orally once daily | Drug | RAL + DRV/RTV |
Primary outcome
Proportion of Participants With Virologic Failure After Initiating RAL Plus DRV/RTV at or Prior to Week 24
Time frame: From start of study treatment to week 24
Virologic failure is defined as: at week 12, confirmed plasma HIV-1 RNA >= 1000 copies/ml or confirmed rebound from the week 4 value by >0.5 log10 copies/ml (for subjects with week 4 value <= 50 copies/ml, confirmed rebound to >50 copies/ml); at week 24 or later, confirmed value > 50 copies/ml. Viral load confirmation was scheduled 7-35 days after initial virologic failure. The proportion was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.
16 secondary outcomes
Proportion of Participants With Virologic Failure or Off Study Treatment Regimen or Death at or Prior to Week 24
Time frame: From start of study treatment to Week 24
Change in Plasma HIV-1 RNA From Baseline to Week 1
Time frame: Baseline and week 1
Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/ml or <200 Copies/ml at Week 24
Time frame: From start of study treatment to week 24
Proportion of Participants With Plasma HIV-1 RNA <50 Copies/ml or <200 Copies/ml at Week 48
Time frame: From start of study treatment to week 48
Proportion of Participants Who Experienced Signs/Symptoms or Laboratory Toxicities Grade 3 or Higher, or of Any Grade Which Led to a Permanent Change or Discontinuation of Study Treatment
Time frame: From start of study treatment to week 52
Number of Participants With Pretreatment Drug Resistance
Time frame: At screening
Number of Participants With Integrase Drug Resistance at Virologic Failure
Time frame: From 12 weeks after starting study treatment to week 52
Number of Participants With Protease Drug Resistance at Virologic Failure
Time frame: From 12 weeks after starting study treatment to week 52
Number of Participants With Perfect Overall Adherence by Self Report
Time frame: From one week after starting study treatment to week 52
Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 24
Time frame: From start of study treatment through week 24
Change in Fasting Low-density Lipoprotein at Week 24
Time frame: From start of study treatment through week 24
Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 48
Time frame: From start of study treatment through week 48
Change in Fasting Low-density Lipoprotein at Week 48
Time frame: From start of study treatment through week 48
Change in CD4 Count at Week 48
Time frame: From start of study treatment through week 48
Plasma Trough Concentration of Raltegravir
Time frame: From start of study treatment to week 52
Plasma Trough Concentration of Darunavir
Time frame: From start of study treatment to week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19155770Capetti AF, Piconi S, Landonio S, Rizzardini G, Perno CF. Is dual therapy with raltegravir and protease inhibitors a feasible option in rescue strategy in HIV-1 infection? J Acquir Immune Defic Syndr. 2009 Feb 1;50(2):233-4. doi: 10.1097/QAI.0b013e31818c7e8e. No abstract available.
- Background: PubMed 19149996Long MC, King JR, Acosta EP. Pharmacologic aspects of new antiretroviral drugs. Curr HIV/AIDS Rep. 2009 Feb;6(1):43-50. doi: 10.1007/s11904-009-0007-y.
- Background: PubMed 19131522Vermeir M, Lachau-Durand S, Mannens G, Cuyckens F, van Hoof B, Raoof A. Absorption, metabolism, and excretion of darunavir, a new protease inhibitor, administered alone and with low-dose ritonavir in healthy subjects. Drug Metab Dispos. 2009 Apr;37(4):809-20. doi: 10.1124/dmd.108.024109. Epub 2009 Jan 8.
- Derived from this study: PubMed 21857490Taiwo B, Zheng L, Gallien S, Matining RM, Kuritzkes DR, Wilson CC, Berzins BI, Acosta EP, Bastow B, Kim PS, Eron JJ Jr; ACTG A5262 Team. Efficacy of a nucleoside-sparing regimen of darunavir/ritonavir plus raltegravir in treatment-naive HIV-1-infected patients (ACTG A5262). AIDS. 2011 Nov 13;25(17):2113-22. doi: 10.1097/QAD.0b013e32834bbaa9.
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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.
Joseph J. Eron, Jr., MD study chair
University of North Carolina, Chapel Hill
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Raltegravir and Darunavir/Ritonavir in people with HIV-1 Infections, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 22 sites 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 6 inclusion and 10 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 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2011). 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?
Proportion of Participants With Virologic Failure After Initiating RAL Plus DRV/RTV at or Prior to Week 24 (time frame: From start of study treatment to week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00830804, which also lists 4 linked publications.
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 8 Nov 2018.