HIV InfectionsPhase 2NCT00183261
Immune Response to a Therapeutic HIV Vaccine Followed by Treatment Interruption in Patients With Acute or Recent HIV Infection
A Phase 2 study testing MRKAd5 HIV-1 gag/pol/nef in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 23 sites in 3 countries.
Trial summary
The purpose of this study is to determine whether the HIV vaccine MRKAd5 HIV-1 gag/pol/nef followed by treatment interruption can increase immune system function in adults with acute or recent HIV infection who have started taking anti-HIV drugs. 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?
- MRKAd5 HIV-1 gag/pol/nef
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 23 sitesin 3 countries
- Study dates
- Mar 2006to Oct 2010
- 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
- Initiated HAART within 30 days of an acute or recent HIV-1 infection diagnosis. More information on this criterion can be found in the protocol.
- Initiated HAART within 30 days of documented acute or recent HIV-1 infection without interruption for more than 7 days
- Sustained viral suppression, defined as a viral load of 500 copies/mL or less 12 months prior to baseline with an undetectable HIV-1 RNA viral load between 60 to 7 days prior to baseline
- CD4 count of 450 cells/mm3 or more OR 35% or more between 60 to 14 days prior to baseline
- Ad5 neutralizing antibody titer of 200 or less at screening
- Willing to follow all study procedures and schedules
Show all 10Show fewer
- Willing to interrupt HAART for at least 24 weeks following completion of the vaccination stage
- Negative for hepatitis B surface antigen (HBsAg) at screening
- Willing to use acceptable forms of contraception
- Infected with HIV-1 subtype B, if this information is available
Who cannot join
- Virologic relapse, defined as 2 consecutive measurements of viral load of 500 copies/mL or more at least 7 days apart within 12 months of baseline visit
- Received more than 7 days of continuous HAART other than that received within 16 days of acute or recent HIV-1 infection. Participants who received HAART as part of post-exposure prophylaxis (PEP) more than 6 months prior to the start of initial HAART may be eligible, provided that they did not acquire HIV-1 infection from the event that required PEP.
- History of anaphylaxis or allergy to vaccine components, including Tris buffer, magnesium chloride, and polysorbate 80 (Tween)
- History of clinically significant heart, lung, kidney, liver, pancreatic, gastrointestinal, or neurological disease that, in the opinion of the study investigator, may interfere with the study
- Contraindication to intramuscular (IM) injection, such as anticoagulant therapy or thrombocytopenia
- Receipt of any immune globulin or blood products within 3 months prior to baseline
Show all 16Show fewer
- Receipt of any live vaccine within 30 days prior to baseline or any inactivated vaccine within 14 days prior to baseline
- Previous receipt of any HIV vaccine. Participants that were documented to have received only placebo are not excluded.
- History of any AIDS-defining illness. If a participant's sole AIDS-defining illness is Kaposi's sarcoma limited to the skin and is not anticipated to require systemic chemotherapy, that participant is not excluded.
- Currently receiving drugs or biologics not approved by the Food and Drug Administration (FDA) other than investigational HIV medications
- Current or past participation in other studies that might alter the participant's response to the study vaccination
- Use of any immunomodulatory agents, including but not limited to interleukin-2 (IL-2), granulocyte/macrophage-colony stimulating factor (GM-CSF), and systemic corticosteroids, within 30 days prior to baseline
- Active alcohol or substance use that, in the investigator's opinion, may interfere with the study
- Any other criteria or condition that, in the investigator's opinion, may interfere with the study
- Unwilling or unable to contribute to the planned peripheral blood mononuclear cell (PBMC) blood collection
- Pregnancy or breastfeeding
Trial locations and contacts
23 sites in 3 countries.
23 sites in 3 countries
United States13 sites
Fenway Community Health Ctr. CRS
Boston, Massachusetts, 02115
Unc Aids Crs
Chapel Hill, North Carolina, 27514
UNC, Chapel Hill AIEDRP
Chapel Hill, North Carolina, 27599
Univ. of Colorado Health Sciences Ctr. AIEDRP
Denver, Colorado, 80220
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, 27710
Dumc Aiedrp
Durham, North Carolina
Beth Israel Med. Ctr., ACTU
New York, New York, 10003
Aaron Diamond AIDS Research Ctr. AIEDRP
New York, New York, 10016
The Miriam Hosp. ACTG CRS
Providence, Rhode Island, 02906
Ucsd Aiedrp
San Diego, California, 92103
Ucsf Aiedrp
San Francisco, California, 94110
Washington U CRS
St Louis, Missouri, 63110
LA Biomedical Research Institute at Harbor-UCLA AIEDRP
Torrance, California
Australia9 sites
Holdsworth House Medical Practice CRS
Darlinghurst, New South Wales, 2010
St. Vincent's Hospital CRS
Darlinghurst, New South Wales, 2010
Taylor Square Private Clinic CRS
Darlinghurst, New South Wales, 2010
AIDS Research Initiative, Darlinghurst CRS
Darlinghurst, New South Wales
407 Doctors (Australia) AIEDRP
Sydney, 2010
AIDS Research Initiative (Australia) AIEDRP
Sydney, 2010
St. Vincent's Hosp. (Australia) AIEDRP
Sydney, 2010
Taylor Square Private Clinic (Australia) AIEDRP
Sydney, 2010
Holdsworth House Gen. Practice (Australia) AIEDRP
Sydney
American Samoa1 site
407 Doctors CRS
Surry Hills, New South Wales, 2010
About this study
Official title: A Randomized Phase II Study of Therapeutic Immunization and Treatment Interruption Among Subjects Who Began Potent Antiretroviral Therapy Within 30 Days of Diagnosis of Acute or Recent HIV Infection
The purpose of this study is to determine whether the HIV vaccine MRKAd5 HIV-1 gag/pol/nef followed by treatment interruption can increase immune system function in adults with acute or recent HIV infection who have started taking anti-HIV drugs.
Read the detailed description
While the advent of highly active antiretroviral therapy (HAART) has contributed to the increasing control of HIV infection and viral replication, ultimate control of HIV infection will require the development of effective HIV-specific immunity in HIV infected individuals. Therapeutic vaccination within the earliest weeks following acute or recent HIV infection may increase the immune system's response to HIV. This study will determine whether MRKAd5 HIV-1 gag/pol/nef vaccine followed by treatment interruption can maintain viral suppression in patients with acute or recent HIV infection.
The interventional part of the study will last 102 weeks. Participants will be randomly assigned to receive either MRKAd5 HIV-1 gag/pol/nef or placebo vaccine at baseline and Weeks 4 and 26. Participants must remain on HAART from study entry until Week 38. Participants whose HIV viral load rebounds two times or more above 500 copies/ml by Weeks 39 to 41 will not enter Step 2 of the study. Participants whose viral load drops to 500 copies/ml or less by Weeks 39 to 41 will enter Step 2, where they will discontinue HAART for 24 weeks. Participants in Step 2 will have plasma HIV viral loads measured every 2 weeks for the first 4 weeks and weekly for the next 3 weeks. Study participants will continue in Step 2 until they experience virologic and immunologic failure or they need to restart HAART for another reason; they will then enter Step 3, where they will reinitiate HAART. Step 3 participants will continue on HAART until Week 102. A long-term safety follow-up period will occur from Weeks 103 to 240.
Timing of the study visits will be determined by which steps a participant enters. A physical exam and blood and urine collection will occur at most study visits throughout the study until Week 102. Follow-up phone calls to study participants will occur every 6 months from Week 102 until Week 240 to collect long-term safety data, including clinical status, CD4 count, and medication history. During the long-term safety follow-up, participants will also have study visits every 6 months. Visits will include medical and medication history.
- Conditions
- HIV Infections
- Being tested
- MRKAd5 HIV-1 gag/pol/nef, MRKAd5 HIV-1 gag/pol/nef placebo
- Keywords
- Treatment Interruption, HIV Therapeutic Vaccine, Acute Infection, Acute Retroviral Syndrome
- Medical subject headings
- HIV Infections, Acute Retroviral Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRKAd5 HIV-1 gag/pol/nefBiological
1.5 x 1010 Ad vg/mL, 1.0 mL administered intramuscularly
MRKAd5 HIV-1 gag/pol/nef placeboBiological
1.0 mL administered intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive the MRKAd5 HIV-1 gag/pol/nef vaccine at study entry and on Weeks 4 and 26 Receives: Biological: MRKAd5 HIV-1 gag/pol/nef |
| 2 | Placebo comparator | Participants will receive the MRKAd5 HIV-1 gag/pol/nef vaccine placebo at study entry and on Weeks 4 and 26 Receives: Biological: MRKAd5 HIV-1 gag/pol/nef placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average of log10 HIV-1 RNA viral load
Measured: At Weeks 58 and 63
Frequency of Grade 3 or 4 systemic adverse events, the occurrence of a severe or life-threatening injection site adverse event, or death
Measured: Throughout study
Secondary outcomes (13)
Distribution of plasma HIV RNA viral load
Measured: At Weeks 63 and 87
Proportion of patients with controlled viremia and their respective distribution of plasma HIV RNA viral load
Measured: At Weeks 63 and 87
Mean viral burden, defined as time-averaged area under the log10 HIV-1 RNA viral load curve
Measured: At Weeks 63 and 87
HIV DNA levels
Measured: At Weeks 30, 38, 63, and 87
HIV-1 DNA levels
Measured: At Weeks 30, 38, 46, 50, 63, and 87
Magnitude and absolute change in CD4 and CD8 counts
Measured: At Weeks 63 and 87
Percent and absolute change in the number of HIV-1- specific CD8 cells, as measured by interferon (IFN)-gamma Elispot assay and intracellular cytokine staining
Measured: Through Week 30
Percent and absolute change in the cytokine secretion patterns and the proliferative capacity of HIV-1- specific CD4 and CD8 cells, as measured by multiparameter flow cytometry
Measured: Through Week 30
Breadth and magnitude of HIV-1- specific CD4 and CD8 cell responses
Measured: Throughout study
Time to reach the specified virologic or immunologic criteria for reinitiating antiretroviral therapy after treatment interruption
Measured: Throughout study
Frequency of Grade 3 or 4 systemic adverse events or the occurrence of a severe or life-threatening injection site adverse event, or HIV-related events, AIDS-defining infections, and death from time of vaccination
Measured: Throughout study
Cell-associated infectivity in latently infected cells
Measured: At Week 63
Cell-associated infectivity at Week 63 and immunologic responses
Measured: At Weeks 63 and 87
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMar 2006
- Primary completionAug 2007
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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, Care provider
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Acute Infection and Early Disease Research Program, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Responsible party
- Sponsor
- Investigators
- Susan Little, MD, Study chair, University of California, San Diego AIDS Vaccine Research CenterDouglas D. Richman, MD, Study chair, Departments of Pathology and Medicine, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183261
- Sponsor's protocol ID
- AIN504/A5218
- Other IDs
- 10025, AIN504/ACTG A5218, AIN504-A5218
- Status last verified
- Oct 2021
- First submitted
- 13 Sep 2005
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
Markowitz M, Jin X, Hurley A, Simon V, Ramratnam B, Louie M, Deschenes GR, Ramanathan M Jr, Barsoum S, Vanderhoeven J, He T, Chung C, Murray J, Perelson AS, Zhang L, Ho DD. Discontinuation of antiretroviral therapy commenced early during the course of human immunodeficiency virus type 1 infection, with or without adjunctive vaccination. J Infect Dis. 2002 Sep 1;186(5):634-43. doi: 10.1086/342559. Epub 2002 Aug 9.
PubMed 12195350Moss 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 12559781Papasavvas E, Ortiz GM, Gross R, Sun J, Moore EC, Heymann JJ, Moonis M, Sandberg JK, Drohan LA, Gallagher B, Shull J, Nixon DF, Kostman JR, Montaner LJ. Enhancement of human immunodeficiency virus type 1-specific CD4 and CD8 T cell responses in chronically infected persons after temporary treatment interruption. J Infect Dis. 2000 Sep;182(3):766-75. doi: 10.1086/315748. Epub 2000 Aug 17.
PubMed 10950770Rosenberg ES, Altfeld M, Poon SH, Phillips MN, Wilkes BM, Eldridge RL, Robbins GK, D'Aquila RT, Goulder PJ, Walker BD. Immune control of HIV-1 after early treatment of acute infection. Nature. 2000 Sep 28;407(6803):523-6. doi: 10.1038/35035103.
PubMed 11029005
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Therapeutic Immunization and Treatment Interruption Among Subjects Who Began Potent Antiretroviral Therapy Within 30 Days of Diagnosis of Acute or Recent HIV Infection
- ClinicalTrials.gov ID
- NCT00183261
- Acronym / sponsor ID
- AIN504/A5218
- Conditions
- HIV Infections
- Keywords
- Treatment Interruption, HIV Therapeutic Vaccine, Acute Infection, Acute Retroviral Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Acute Infection and Early Disease Research Program, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Study start
- Mar 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 16 Sep 2005 (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.
The purpose of this study is to determine whether the HIV vaccine MRKAd5 HIV-1 gag/pol/nef followed by treatment interruption can increase immune system function in adults with acute or recent HIV infection who have started taking anti-HIV drugs.
Detailed description
While the advent of highly active antiretroviral therapy (HAART) has contributed to the increasing control of HIV infection and viral replication, ultimate control of HIV infection will require the development of effective HIV-specific immunity in HIV infected individuals. Therapeutic vaccination within the earliest weeks following acute or recent HIV infection may increase the immune system's response to HIV. This study will determine whether MRKAd5 HIV-1 gag/pol/nef vaccine followed by treatment interruption can maintain viral suppression in patients with acute or recent HIV infection.
The interventional part of the study will last 102 weeks. Participants will be randomly assigned to receive either MRKAd5 HIV-1 gag/pol/nef or placebo vaccine at baseline and Weeks 4 and 26. Participants must remain on HAART from study entry until Week 38. Participants whose HIV viral load rebounds two times or more above 500 copies/ml by Weeks 39 to 41 will not enter Step 2 of the study. Participants whose viral load drops to 500 copies/ml or less by Weeks 39 to 41 will enter Step 2, where they will discontinue HAART for 24 weeks. Participants in Step 2 will have plasma HIV viral loads measured every 2 weeks for the first 4 weeks and weekly for the next 3 weeks. Study participants will continue in Step 2 until they experience virologic and immunologic failure or they need to restart HAART for another reason; they will then enter Step 3, where they will reinitiate HAART. Step 3 participants will continue on HAART until Week 102. A long-term safety follow-up period will occur from Weeks 103 to 240.
Timing of the study visits will be determined by which steps a participant enters. A physical exam and blood and urine collection will occur at most study visits throughout the study until Week 102. Follow-up phone calls to study participants will occur every 6 months from Week 102 until Week 240 to collect long-term safety data, including clinical status, CD4 count, and medication history. During the long-term safety follow-up, participants will also have study visits every 6 months. Visits will include medical and medication history.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: MRKAd5 HIV-1 gag/pol/nefParticipants will receive the MRKAd5 HIV-1 gag/pol/nef vaccine at study entry and on Weeks 4 and 26 |
| 2 | Placebo comparator | Biological: MRKAd5 HIV-1 gag/pol/nef placeboParticipants will receive the MRKAd5 HIV-1 gag/pol/nef vaccine placebo at study entry and on Weeks 4 and 26 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Initiated HAART within 30 days of an acute or recent HIV-1 infection diagnosis. More information on this criterion can be found in the protocol.
- Initiated HAART within 30 days of documented acute or recent HIV-1 infection without interruption for more than 7 days
- Sustained viral suppression, defined as a viral load of 500 copies/mL or less 12 months prior to baseline with an undetectable HIV-1 RNA viral load between 60 to 7 days prior to baseline
- CD4 count of 450 cells/mm3 or more OR 35% or more between 60 to 14 days prior to baseline
- Ad5 neutralizing antibody titer of 200 or less at screening
Key exclusion criteria (16 listed)
- Virologic relapse, defined as 2 consecutive measurements of viral load of 500 copies/mL or more at least 7 days apart within 12 months of baseline visit
- Received more than 7 days of continuous HAART other than that received within 16 days of acute or recent HIV-1 infection. Participants who received HAART as part of post-exposure prophylaxis (PEP) more than 6 months prior to the start of initial HAART may be eligible, provided that they did not acquire HIV-1 infection from the event that required PEP.
- History of anaphylaxis or allergy to vaccine components, including Tris buffer, magnesium chloride, and polysorbate 80 (Tween)
- History of clinically significant heart, lung, kidney, liver, pancreatic, gastrointestinal, or neurological disease that, in the opinion of the study investigator, may interfere with the study
- Contraindication to intramuscular (IM) injection, such as anticoagulant therapy or thrombocytopenia
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 |
|---|---|---|
| MRKAd5 HIV-1 gag/pol/nef1.5 x 1010 Ad vg/mL, 1.0 mL administered intramuscularly | Biological | 1 |
| MRKAd5 HIV-1 gag/pol/nef placebo1.0 mL administered intramuscularly | Biological | 2 |
Primary outcome
Average of log10 HIV-1 RNA viral load
Time frame: At Weeks 58 and 63
Frequency of Grade 3 or 4 systemic adverse events, the occurrence of a severe or life-threatening injection site adverse event, or death
Time frame: Throughout study
13 secondary outcomes
Distribution of plasma HIV RNA viral load
Time frame: At Weeks 63 and 87
Proportion of patients with controlled viremia and their respective distribution of plasma HIV RNA viral load
Time frame: At Weeks 63 and 87
Mean viral burden, defined as time-averaged area under the log10 HIV-1 RNA viral load curve
Time frame: At Weeks 63 and 87
HIV DNA levels
Time frame: At Weeks 30, 38, 63, and 87
HIV-1 DNA levels
Time frame: At Weeks 30, 38, 46, 50, 63, and 87
Magnitude and absolute change in CD4 and CD8 counts
Time frame: At Weeks 63 and 87
Percent and absolute change in the number of HIV-1- specific CD8 cells, as measured by interferon (IFN)-gamma Elispot assay and intracellular cytokine staining
Time frame: Through Week 30
Percent and absolute change in the cytokine secretion patterns and the proliferative capacity of HIV-1- specific CD4 and CD8 cells, as measured by multiparameter flow cytometry
Time frame: Through Week 30
Breadth and magnitude of HIV-1- specific CD4 and CD8 cell responses
Time frame: Throughout study
Time to reach the specified virologic or immunologic criteria for reinitiating antiretroviral therapy after treatment interruption
Time frame: Throughout study
Frequency of Grade 3 or 4 systemic adverse events or the occurrence of a severe or life-threatening injection site adverse event, or HIV-related events, AIDS-defining infections, and death from time of vaccination
Time frame: Throughout study
Cell-associated infectivity in latently infected cells
Time frame: At Week 63
Cell-associated infectivity at Week 63 and immunologic responses
Time frame: At Weeks 63 and 87
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 1 Nov 2021.
- Background: PubMed 12195350Markowitz M, Jin X, Hurley A, Simon V, Ramratnam B, Louie M, Deschenes GR, Ramanathan M Jr, Barsoum S, Vanderhoeven J, He T, Chung C, Murray J, Perelson AS, Zhang L, Ho DD. Discontinuation of antiretroviral therapy commenced early during the course of human immunodeficiency virus type 1 infection, with or without adjunctive vaccination. J Infect Dis. 2002 Sep 1;186(5):634-43. doi: 10.1086/342559. Epub 2002 Aug 9.
- 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.
- Background: PubMed 10950770Papasavvas E, Ortiz GM, Gross R, Sun J, Moore EC, Heymann JJ, Moonis M, Sandberg JK, Drohan LA, Gallagher B, Shull J, Nixon DF, Kostman JR, Montaner LJ. Enhancement of human immunodeficiency virus type 1-specific CD4 and CD8 T cell responses in chronically infected persons after temporary treatment interruption. J Infect Dis. 2000 Sep;182(3):766-75. doi: 10.1086/315748. Epub 2000 Aug 17.
- Background: PubMed 11029005Rosenberg ES, Altfeld M, Poon SH, Phillips MN, Wilkes BM, Eldridge RL, Robbins GK, D'Aquila RT, Goulder PJ, Walker BD. Immune control of HIV-1 after early treatment of acute infection. Nature. 2000 Sep 28;407(6803):523-6. doi: 10.1038/35035103.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Susan Little, MD study chair
University of California, San Diego AIDS Vaccine Research Center
Douglas D. Richman, MD study chair
Departments of Pathology and Medicine, University of California, San Diego
23 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MRKAd5 HIV-1 gag/pol/nef in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 23 sites in 3 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 16 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 1 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 23 sites in United States, Australia, American Samoa. 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?
Average of log10 HIV-1 RNA viral load (time frame: At Weeks 58 and 63). 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 NCT00183261, 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 1 Nov 2021.