HIV InfectionsPhase 2NCT00080106
Effectiveness of and Immune Response to HIV Vaccination Followed by Treatment Interruption in HIV Infected Patients
A Phase 2 study testing MRK Ad5 HIV-1 gag vaccine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 28 sites in 2 countries.
Trial summary
HIV vaccines may help the immune systems of HIV infected patients better control the virus. The goal of this study is to determine whether patients on anti-HIV medications can stop taking those medications if they receive an HIV vaccine. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- MRK Ad5 HIV-1 gag vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 28 sitesin 2 countries
- Study dates
- Jun 2004to May 2011
- Phase
- Phase 2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HIV infected
- On a stable antiretroviral medication regimen (no changes to treatment within 4 weeks of study entry)
- Viral load less than 50 copies/ml
- Viral suppression for 2 years prior to study entry (documented viral loads less than 500 copies/ml)
- CD4 count of 500 cells/mm3 or greater
- Ad5 neutralizing antibody less than 200 units at screening
Show all 10Show fewer
- Willing to stop antiretroviral medications for at least 16 weeks post-vaccination
- Hepatitis B surface antigen negative
- Weight more than 110 lbs
- Willing to use acceptable methods of contraception
Who cannot join
- Two consecutive viral loads of 500 copies/ml or greater at least 14 days apart during the 24 months prior to study entry
- Two consecutive CD4 counts less than 200 cells/mm3 before starting antiretroviral medications
- History of anaphylaxis
- Allergy to vaccine components
- History of cardiac, pulmonary, gastrointestinal, hepatic, renal, pancreatic, or neurologic disease which, in the opinion of the study official, will compromise study participation
- Pregnancy or breastfeeding
Show all 15Show fewer
- Contraindication to intramuscular injection, such as anticoagulant therapy or thrombocytopenia
- Immune globulin or blood products within 3 months prior to study entry
- Live vaccine within 30 days prior to study entry
- Inactivated vaccine within 14 days prior to study entry
- Previous HIV vaccine
- History of an AIDS-defining illness. Patients with a history of Kaposi's sarcoma limited to the skin may participate.
- Currently taking drugs or other substances not approved by the FDA. Patients may be on antiretroviral agents not yet approved by the FDA as part of a clinical trial or through an expanded access program.
- Immunomodulatory agents (interferon, IL-2, GM-CSF, systemic corticosteroids, etc.) within 30 days prior to study entry
- Active alcohol or substance abuse which may interfere with the study
Trial locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
United States27 sites
IHV Baltimore Treatment CRS
Baltimore, Maryland, 21201
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, 02114
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, 02215
Unc Aids Crs
Chapel Hill, North Carolina, 27514
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, 60612
Case CRS
Cleveland, Ohio, 44106
MetroHealth CRS
Cleveland, Ohio, 44109
The Ohio State University Medical Center
Columbus, Ohio, 43210
Univ. of Texas Medical Branch, ACTU
Galveston, Texas
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 46202-5250
UCLA CARE Center CRS
Los Angeles, California, 90035
Univ. of Miami AIDS CRS
Miami, Florida, 33136
University of Minnesota, ACTU
Minneapolis, Minnesota, 55455
Beth Israel Med. Ctr., ACTU
New York, New York, 10003
NY Univ. HIV/AIDS CRS
New York, New York, 10016
Cornell CRS
New York, New York, 10021
Stanford CRS
Palo Alto, California, 94304-5350
Pitt CRS
Pittsburgh, Pennsylvania, 15213
The Miriam Hosp. ACTG CRS
Providence, Rhode Island, 02906
AIDS Care CRS
Rochester, New York, 14607
Univ. of Rochester ACTG CRS
Rochester, New York, 14642
Univ. of California Davis Med. Ctr., ACTU
Sacramento, California, 95817
Ucsd, Avrc Crs
San Diego, California, 92103
Ucsf Aids Crs
San Francisco, California, 94110
University of Washington AIDS CRS
Seattle, Washington, 98104
Washington U CRS
St Louis, Missouri, 63110
About this study
Official title: A Phase II Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Antiretroviral Effect of Immunization With the MRK Ad5 HIV-1 Gag Vaccine in HIV-1 Infected Individuals Who Interrupt Antiretroviral Therapy
HIV vaccines may help the immune systems of HIV infected patients better control the virus. The goal of this study is to determine whether patients on anti-HIV medications can stop taking those medications if they receive an HIV vaccine. While taking anti-HIV medications, participants will receive either an HIV vaccine or a placebo. Participants will then stop taking their anti-HIV medications and the study will compare the viral loads of participants who received the vaccine with the viral loads of participants who received the placebo.
Primary study hypotheses: 1)The Week 12 and Week 16 post-ART interruption geometric mean HIV-1 RNA levels will be lower among participants who had received MRK Ad5 vaccine prior to ART interruption than among participants who received placebo; 2) the time averaged area under the curve of the log10 HIV-1 RNA copies/ml versus day function in the 16 week post-ART interruption step will be lower among participants who received the MRK Ad5 vaccine prior to ART interruption than among participants who receive placebo.
Read the detailed description
Antiretroviral therapy (ART) has a significant impact on HIV disease; however, HIV cannot be cured with current drug regimens. While the majority of patients initially benefit from ART, drug regimens subsequently fail for many patients due to drug resistance, poor adherence, or toxicity. If given while HIV replication is kept in check by ART, an HIV vaccine may be able to generate an effective long-term immune response capable of controlling the virus, even if ART is discontinued.
The MRK Ad5 HIV-1 gag vaccine uses a replication-defective adenovirus vector and has been found safe in clinical trials of both HIV infected and HIV uninfected adults. This study will evaluate the ability of immunization with the MRK Ad5 HIV-1 gag vaccine to control HIV replication in individuals undergoing treatment interruption. The study will enroll individuals whose HIV replication has been successfully suppressed with ART for at least 2 years.
Participants in this study will be randomly assigned to receive either vaccine or placebo. Both vaccine and placebo will be injected into the upper arm muscle. Participants will take their antiretroviral medications during the first 3 months of the study. Injections will be given on Day 1, Week 4, and Week 26. A study nurse will call participants 1 or 2 days after each injection and participants will be asked to fill out a card with any reactions they have to the injections. About 3 months after the third injection, participants will stop taking their antiretroviral medications for 4 months. Participants will have study visits every 2 to 3 weeks while off medication. After 4 months, participants will have the option of restarting antiretroviral medications or continuing without medication. Participants will then have study visits every 2 months for 8 months. Study visits will include physical exams and blood collection.
All participants will continue to see their primary care provider for HIV treatment and will be restarted on antiretroviral medications if clinically indicated. Participants or their primary care provider will be contacted by phone for updates every 6 months for an additional 3.5 years.
- Conditions
- HIV Infections
- Being tested
- MRK Ad5 HIV-1 gag vaccine, Vaccine placebo
- Keywords
- HIV Therapeutic Vaccine, Treatment Experienced, Treatment Interruption, Adenovirus Vector
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRK Ad5 HIV-1 gag vaccineBiological
MRK Ad5 HIV-1 gag vaccine injected into the upper arm muscle.
Vaccine placeboOther
MRK Ad5 HIV-1 gag placebo vaccine injected into the upper arm muscle.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants in the experimental arm will receive the MRK Ad5 HIV-1 gag vaccine on Day 1, Week 4 and Week 26. Participants will take their antiretroviral medications during the first 3 months of the study. Receives: Biological: MRK Ad5 HIV-1 gag vaccine |
| 2 | Placebo comparator | Participants in Arm 2 will receive a placebo vaccine on Day 1, Week 4 and Week 26. Participants will take their antiretroviral medications during the first 3 months of the study. Receives: Other: Vaccine placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analytical treatment interruption (ATI) HIV-1 RNA set-point
Measured: Throughout study
ATI log10 HIV-1 RNA copies/ml at all scheduled evaluations during Step II (ATI)
Measured: Throughout Step 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2004 (estimated)
- Study startJun 2004
- Primary completionSep 2007
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert T. Schooley, MD, Study chair, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080106
- Sponsor's protocol ID
- A5197
- Other IDs
- 10014, ACTG A5197
- Status last verified
- Jul 2013
- First submitted
- 23 Mar 2004
- Last updated
- 9 Nov 2021
- Results posted
- No
Publications
Shiver JW, Fu TM, Chen L, Casimiro DR, Davies ME, Evans RK, Zhang ZQ, Simon AJ, Trigona WL, Dubey SA, Huang L, Harris VA, Long RS, Liang X, Handt L, Schleif WA, Zhu L, Freed DC, Persaud NV, Guan L, Punt KS, Tang A, Chen M, Wilson KA, Collins KB, Heidecker GJ, Fernandez VR, Perry HC, Joyce JG, Grimm KM, Cook JC, Keller PM, Kresock DS, Mach H, Troutman RD, Isopi LA, Williams DM, Xu Z, Bohannon KE, Volkin DB, Montefiori DC, Miura A, Krivulka GR, Lifton MA, Kuroda MJ, Schmitz JE, Letvin NL, Caulfield MJ, Bett AJ, Youil R, Kaslow DC, Emini EA. Replication-incompetent adenoviral vaccine vector elicits effective anti-immunodeficiency-virus immunity. Nature. 2002 Jan 17;415(6869):331-5. doi: 10.1038/415331a.
PubMed 11797011Ortiz GM, Wellons M, Brancato J, Vo HT, Zinn RL, Clarkson DE, Van Loon K, Bonhoeffer S, Miralles GD, Montefiori D, Bartlett JA, Nixon DF. Structured antiretroviral treatment interruptions in chronically HIV-1-infected subjects. Proc Natl Acad Sci U S A. 2001 Nov 6;98(23):13288-93. doi: 10.1073/pnas.221452198. Epub 2001 Oct 30.
PubMed 11687611Moss RB, Brandt C, Giermakowska WK, Savary JR, Theofan G, Zanetti M, Carlo DJ, Wallace MR. HIV-specific immunity during structured antiviral drug treatment interruption. Vaccine. 2003 Mar 7;21(11-12):1066-71. doi: 10.1016/s0264-410x(02)00610-2.
PubMed 12559781Schooley RT, Spritzler J, Wang H, Lederman MM, Havlir D, Kuritzkes DR, Pollard R, Battaglia C, Robertson M, Mehrotra D, Casimiro D, Cox K, Schock B; AIDS Clinical Trials Group 5197 Study Team. AIDS clinical trials group 5197: a placebo-controlled trial of immunization of HIV-1-infected persons with a replication-deficient adenovirus type 5 vaccine expressing the HIV-1 core protein. J Infect Dis. 2010 Sep 1;202(5):705-16. doi: 10.1086/655468.
PubMed 20662716Li JZ, Heisey A, Ahmed H, Wang H, Zheng L, Carrington M, Wrin T, Schooley RT, Lederman MM, Kuritzkes DR; ACTG A5197 Study Team. Relationship of HIV reservoir characteristics with immune status and viral rebound kinetics in an HIV therapeutic vaccine study. AIDS. 2014 Nov 28;28(18):2649-57. doi: 10.1097/QAD.0000000000000478.
PubMed 25254301Li JZ, Christensen JA, Wang H, Spritzler J, Kuritzkes DR; AIDS Clinical Trials Group A5197 Study Team. Evaluation of HIV-1 ambiguous nucleotide frequency during antiretroviral treatment interruption. J Acquir Immune Defic Syndr. 2012 Sep 1;61(1):19-22. doi: 10.1097/QAI.0b013e318264460f.
PubMed 22732468Li JZ, Brumme CJ, Lederman MM, Brumme ZL, Wang H, Spritzler J, Carrington M, Medvik K, Walker BD, Schooley RT, Kuritzkes DR; AIDS Clinical Trials Group A5197 Study Team. Characteristics and outcomes of initial virologic suppressors during analytic treatment interruption in a therapeutic HIV-1 gag vaccine trial. PLoS One. 2012;7(3):e34134. doi: 10.1371/journal.pone.0034134. Epub 2012 Mar 30.
PubMed 22479542Li JZ, Brumme ZL, Brumme CJ, Wang H, Spritzler J, Robertson MN, Lederman MM, Carrington M, Walker BD, Schooley RT, Kuritzkes DR; AIDS Clinical Trials Group A5197 Study Team. Factors associated with viral rebound in HIV-1-infected individuals enrolled in a therapeutic HIV-1 gag vaccine trial. J Infect Dis. 2011 Apr 1;203(7):976-83. doi: 10.1093/infdis/jiq143.
PubMed 21402549
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Antiretroviral Effect of Immunization With the MRK Ad5 HIV-1 Gag Vaccine in HIV-1 Infected Individuals Who Interrupt Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT00080106
- Acronym / sponsor ID
- A5197
- Conditions
- HIV Infections
- Keywords
- HIV Therapeutic Vaccine, Treatment Experienced, Treatment Interruption, Adenovirus Vector
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jun 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 25 Mar 2004 (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.
HIV vaccines may help the immune systems of HIV infected patients better control the virus. The goal of this study is to determine whether patients on anti-HIV medications can stop taking those medications if they receive an HIV vaccine. While taking anti-HIV medications, participants will receive either an HIV vaccine or a placebo. Participants will then stop taking their anti-HIV medications and the study will compare the viral loads of participants who received the vaccine with the viral loads of participants who received the placebo.
Primary study hypotheses: 1)The Week 12 and Week 16 post-ART interruption geometric mean HIV-1 RNA levels will be lower among participants who had received MRK Ad5 vaccine prior to ART interruption than among participants who received placebo; 2) the time averaged area under the curve of the log10 HIV-1 RNA copies/ml versus day function in the 16 week post-ART interruption step will be lower among participants who received the MRK Ad5 vaccine prior to ART interruption than among participants who receive placebo.
Detailed description
Antiretroviral therapy (ART) has a significant impact on HIV disease; however, HIV cannot be cured with current drug regimens. While the majority of patients initially benefit from ART, drug regimens subsequently fail for many patients due to drug resistance, poor adherence, or toxicity. If given while HIV replication is kept in check by ART, an HIV vaccine may be able to generate an effective long-term immune response capable of controlling the virus, even if ART is discontinued.
The MRK Ad5 HIV-1 gag vaccine uses a replication-defective adenovirus vector and has been found safe in clinical trials of both HIV infected and HIV uninfected adults. This study will evaluate the ability of immunization with the MRK Ad5 HIV-1 gag vaccine to control HIV replication in individuals undergoing treatment interruption. The study will enroll individuals whose HIV replication has been successfully suppressed with ART for at least 2 years.
Participants in this study will be randomly assigned to receive either vaccine or placebo. Both vaccine and placebo will be injected into the upper arm muscle. Participants will take their antiretroviral medications during the first 3 months of the study. Injections will be given on Day 1, Week 4, and Week 26. A study nurse will call participants 1 or 2 days after each injection and participants will be asked to fill out a card with any reactions they have to the injections. About 3 months after the third injection, participants will stop taking their antiretroviral medications for 4 months. Participants will have study visits every 2 to 3 weeks while off medication. After 4 months, participants will have the option of restarting antiretroviral medications or continuing without medication. Participants will then have study visits every 2 months for 8 months. Study visits will include physical exams and blood collection.
All participants will continue to see their primary care provider for HIV treatment and will be restarted on antiretroviral medications if clinically indicated. Participants or their primary care provider will be contacted by phone for updates every 6 months for an additional 3.5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: MRK Ad5 HIV-1 gag vaccineParticipants in the experimental arm will receive the MRK Ad5 HIV-1 gag vaccine on Day 1, Week 4 and Week 26. Participants will take their antiretroviral medications during the first 3 months of the study. |
| 2 | Placebo comparator | Other: Vaccine placeboParticipants in Arm 2 will receive a placebo vaccine on Day 1, Week 4 and Week 26. Participants will take their antiretroviral medications during the first 3 months of the study. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- HIV infected
- On a stable antiretroviral medication regimen (no changes to treatment within 4 weeks of study entry)
- Viral load less than 50 copies/ml
- Viral suppression for 2 years prior to study entry (documented viral loads less than 500 copies/ml)
- CD4 count of 500 cells/mm3 or greater
Key exclusion criteria (15 listed)
- Two consecutive viral loads of 500 copies/ml or greater at least 14 days apart during the 24 months prior to study entry
- Two consecutive CD4 counts less than 200 cells/mm3 before starting antiretroviral medications
- History of anaphylaxis
- Allergy to vaccine components
- History of cardiac, pulmonary, gastrointestinal, hepatic, renal, pancreatic, or neurologic disease which, in the opinion of the study official, will compromise study participation
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 |
|---|---|---|
| MRK Ad5 HIV-1 gag vaccineMRK Ad5 HIV-1 gag vaccine injected into the upper arm muscle. | Biological | 1 |
| Vaccine placeboMRK Ad5 HIV-1 gag placebo vaccine injected into the upper arm muscle. | Other | 2 |
Primary outcome
Analytical treatment interruption (ATI) HIV-1 RNA set-point
Time frame: Throughout study
ATI log10 HIV-1 RNA copies/ml at all scheduled evaluations during Step II (ATI)
Time frame: Throughout Step 2
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 9 Nov 2021.
- Background: PubMed 11797011Shiver JW, Fu TM, Chen L, Casimiro DR, Davies ME, Evans RK, Zhang ZQ, Simon AJ, Trigona WL, Dubey SA, Huang L, Harris VA, Long RS, Liang X, Handt L, Schleif WA, Zhu L, Freed DC, Persaud NV, Guan L, Punt KS, Tang A, Chen M, Wilson KA, Collins KB, Heidecker GJ, Fernandez VR, Perry HC, Joyce JG, Grimm KM, Cook JC, Keller PM, Kresock DS, Mach H, Troutman RD, Isopi LA, Williams DM, Xu Z, Bohannon KE, Volkin DB, Montefiori DC, Miura A, Krivulka GR, Lifton MA, Kuroda MJ, Schmitz JE, Letvin NL, Caulfield MJ, Bett AJ, Youil R, Kaslow DC, Emini EA. Replication-incompetent adenoviral vaccine vector elicits effective anti-immunodeficiency-virus immunity. Nature. 2002 Jan 17;415(6869):331-5. doi: 10.1038/415331a.
- Background: PubMed 11687611Ortiz GM, Wellons M, Brancato J, Vo HT, Zinn RL, Clarkson DE, Van Loon K, Bonhoeffer S, Miralles GD, Montefiori D, Bartlett JA, Nixon DF. Structured antiretroviral treatment interruptions in chronically HIV-1-infected subjects. Proc Natl Acad Sci U S A. 2001 Nov 6;98(23):13288-93. doi: 10.1073/pnas.221452198. Epub 2001 Oct 30.
- Background: PubMed 12559781Moss RB, Brandt C, Giermakowska WK, Savary JR, Theofan G, Zanetti M, Carlo DJ, Wallace MR. HIV-specific immunity during structured antiviral drug treatment interruption. Vaccine. 2003 Mar 7;21(11-12):1066-71. doi: 10.1016/s0264-410x(02)00610-2.
- Results publication: PubMed 20662716Schooley RT, Spritzler J, Wang H, Lederman MM, Havlir D, Kuritzkes DR, Pollard R, Battaglia C, Robertson M, Mehrotra D, Casimiro D, Cox K, Schock B; AIDS Clinical Trials Group 5197 Study Team. AIDS clinical trials group 5197: a placebo-controlled trial of immunization of HIV-1-infected persons with a replication-deficient adenovirus type 5 vaccine expressing the HIV-1 core protein. J Infect Dis. 2010 Sep 1;202(5):705-16. doi: 10.1086/655468.
- Derived from this study: PubMed 25254301Li JZ, Heisey A, Ahmed H, Wang H, Zheng L, Carrington M, Wrin T, Schooley RT, Lederman MM, Kuritzkes DR; ACTG A5197 Study Team. Relationship of HIV reservoir characteristics with immune status and viral rebound kinetics in an HIV therapeutic vaccine study. AIDS. 2014 Nov 28;28(18):2649-57. doi: 10.1097/QAD.0000000000000478.
- Derived from this study: PubMed 22732468Li JZ, Christensen JA, Wang H, Spritzler J, Kuritzkes DR; AIDS Clinical Trials Group A5197 Study Team. Evaluation of HIV-1 ambiguous nucleotide frequency during antiretroviral treatment interruption. J Acquir Immune Defic Syndr. 2012 Sep 1;61(1):19-22. doi: 10.1097/QAI.0b013e318264460f.
- Derived from this study: PubMed 22479542Li JZ, Brumme CJ, Lederman MM, Brumme ZL, Wang H, Spritzler J, Carrington M, Medvik K, Walker BD, Schooley RT, Kuritzkes DR; AIDS Clinical Trials Group A5197 Study Team. Characteristics and outcomes of initial virologic suppressors during analytic treatment interruption in a therapeutic HIV-1 gag vaccine trial. PLoS One. 2012;7(3):e34134. doi: 10.1371/journal.pone.0034134. Epub 2012 Mar 30.
- Derived from this study: PubMed 21402549Li JZ, Brumme ZL, Brumme CJ, Wang H, Spritzler J, Robertson MN, Lederman MM, Carrington M, Walker BD, Schooley RT, Kuritzkes DR; AIDS Clinical Trials Group A5197 Study Team. Factors associated with viral rebound in HIV-1-infected individuals enrolled in a therapeutic HIV-1 gag vaccine trial. J Infect Dis. 2011 Apr 1;203(7):976-83. doi: 10.1093/infdis/jiq143.
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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 T. Schooley, MD study chair
University of Colorado, Denver
28 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MRK Ad5 HIV-1 gag vaccine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 28 sites in 2 countries.
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 10 inclusion and 15 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 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Puerto Rico. 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. Some participants in this study may receive a placebo. 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?
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?
Analytical treatment interruption (ATI) HIV-1 RNA set-point (time frame: Throughout study). The study lists 2 primary outcomes in all. 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 NCT00080106, which also lists 8 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 9 Nov 2021.