HIV InfectionsPhase 4NCT00106171
Anti-HIV Medications for People Recently Infected With HIV
A Phase 4 study testing Highly active antiretroviral therapy (HAART) in people with HIV Infections, run by Johns Hopkins Bloomberg School of Public Health at 5 sites in 2 countries.
Trial summary
It is not known if anti-HIV treatment for recently infected patients improves long-term patient prognosis. The purpose of this study is to determine if a one year course of anti-HIV medications slows progression of HIV disease in adults recently infected with HIV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Highly active antiretroviral therapy (HAART)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 5 sitesin 2 countries
- Study dates
- May 2005to May 2012
- Phase
- Phase 4
- 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
- Documented acute or recent HIV infection (infected in the past 12 months) as defined in the study protocol
- Antiretroviral naive. Participants who have taken antiretrovirals for postexposure prophylaxis are eligible for this study.
- Able to swallow tablets or capsules
- Willing to use acceptable forms of contraception
Who cannot join
- Physician unable to design a potentially effective HAART regimen based on results of genotypic resistance testing
- Two CD4 counts of less than 350 cells/mm3 obtained at least 7 days apart within 30 days of study entry
- Viral load less than 5,000 copies/ml within 30 days of study entry in participants who have been infected with HIV-1 for more than six months prior to study entry
- Use of systemic cancer chemotherapy, systemic investigational agents, specific antiretroviral medications, or immunomodulators (growth factors, systemic corticosteroids, HIV vaccines, immune globulin, interleukins, interferons) within 30 days prior to study entry
- Current alcohol or drug use that, in the opinion of the investigator, would interfere with the study
- Serious illness requiring systemic treatment or hospitalization until participant either completes therapy or is clinically stable on therapy for at least 7 days prior to study entry
- Currently involuntarily incarcerated for treatment of either a psychiatric or physical (e.g., infectious disease) illness
- Pregnancy or breastfeeding
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Canada4 sites
CHUM - Hotel-Dieu
Montreal, Quebec, H2W 1T8 CA
Sunnybrook Health Sciences Ctr.
Toronto, Ontario, M4N 3M5 CA
Canadian Immunodeficiency Research Collaborative (CIRC) Inc.
Toronto, Ontario, M5B IL6
University of British Columbia
Vancouver, British Columbia, V6Z2C7
About this study
Official title: A Randomized Trial of HAART in Acute/Early HIV Infection
It is not known if anti-HIV treatment for recently infected patients improves long-term patient prognosis. The purpose of this study is to determine if a one year course of anti-HIV medications slows progression of HIV disease in adults recently infected with HIV.
Study hypothesis: A one-year course of HAART administered during acute or early seroconversion may slow the progression of HIV infection.
Read the detailed description
Although some doctors favor starting anti-HIV treatment as soon as possible after patients learn they are infected, it is not known if treatment for recently infected patients results in slower progression of HIV disease. This study will compare the virologic outcomes of recently infected adults who receive highly active antiretroviral therapy (HAART) with those who receive no treatment. This study will also compare the effects of treatment on patients who enroll within 3 months of seroconversion (acute seroconverters) with patients who enroll within 3 to 12 months of seroconversion (early seroconverters).
This study will last at least 3 years. Participants will be randomly assigned to one of two groups. Group 1 will receive HAART for 1 year; Group 2 will receive no treatment. There will be at least 20 study visits over the 3-year study period. Blood collection will occur at all study visits. A physical exam, medical and medication history, and risk behavior assessment will occur at most visits; participants will also be asked to complete an adherence questionnaire at most visits.
- Conditions
- HIV Infections
- Being tested
- Highly active antiretroviral therapy (HAART)
- Keywords
- HIV, Acute/Early Seroconverters, Acute Infection, Treatment Naive, Primary HIV Infection
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Highly active antiretroviral therapy (HAART)Drug
Regimens will be assigned by investigators
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment Arm | Experimental | Participants will receive immediate HAART for 1 year; then HAART will stopped until clinically indicated. Receives: Drug: Highly active antiretroviral therapy (HAART) |
| Deferred Treatment Arm | No intervention | Participants will receive no immediate HAART, but will receive HAART when HAART is clinically indicated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Treatment-free Time to Initiation of Permanent HAART
All HAART-free time from initial infection with HIV to initiation of permanent HAART
Measured: Through study completion, an average of 18 months
Secondary outcomes (1)
Toxicity as Assessed by the of Number of Participants With Serious Adverse Events
Number of participants with serious adverse events (grade 3 or 4 as defined by the NIH toxicity scale)
Measured: Throughout study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2005 (estimated)
- Study startMay 2005
- Primary completionMay 2012
- Study completionMay 2012
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 (1)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 Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph B. Margolick, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00106171
- Sponsor's protocol ID
- 1R01AI056990-01A1
- Other IDs
- 1R01AI056990-01A1
- Status last verified
- Aug 2023
- First submitted
- 21 Mar 2005
- Last updated
- 13 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Margolick JB, Apuzzo L, Singer J, Wong H, Lee T, Gallant JE, El-Helou P, Loutfy MR, Rachlis A, Fraser C, Kasper K, Tremblay C, Tossonian H, Conway B. A Randomized Trial of Time-Limited Antiretroviral Therapy in Acute/Early HIV Infection. PLoS One. 2015 Nov 24;10(11):e0143259. doi: 10.1371/journal.pone.0143259. eCollection 2015.
PubMed 26600459
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of HAART in Acute/Early HIV Infection
- ClinicalTrials.gov ID
- NCT00106171
- Acronym / sponsor ID
- 1R01AI056990-01A1
- Conditions
- HIV Infections
- Keywords
- HIV, Acute/Early Seroconverters, Acute Infection, Treatment Naive, Primary HIV Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- May 2005
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 22 Mar 2005 (estimated)
- Results
- Posted 13 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is not known if anti-HIV treatment for recently infected patients improves long-term patient prognosis. The purpose of this study is to determine if a one year course of anti-HIV medications slows progression of HIV disease in adults recently infected with HIV.
Study hypothesis: A one-year course of HAART administered during acute or early seroconversion may slow the progression of HIV infection.
Detailed description
Although some doctors favor starting anti-HIV treatment as soon as possible after patients learn they are infected, it is not known if treatment for recently infected patients results in slower progression of HIV disease. This study will compare the virologic outcomes of recently infected adults who receive highly active antiretroviral therapy (HAART) with those who receive no treatment. This study will also compare the effects of treatment on patients who enroll within 3 months of seroconversion (acute seroconverters) with patients who enroll within 3 to 12 months of seroconversion (early seroconverters).
This study will last at least 3 years. Participants will be randomly assigned to one of two groups. Group 1 will receive HAART for 1 year; Group 2 will receive no treatment. There will be at least 20 study visits over the 3-year study period. Blood collection will occur at all study visits. A physical exam, medical and medication history, and risk behavior assessment will occur at most visits; participants will also be asked to complete an adherence questionnaire at most visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment Arm | Experimental | Drug: Highly active antiretroviral therapy (HAART)Participants will receive immediate HAART for 1 year; then HAART will stopped until clinically indicated. |
| Deferred Treatment Arm | No intervention | –Participants will receive no immediate HAART, but will receive HAART when HAART is clinically indicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Documented acute or recent HIV infection (infected in the past 12 months) as defined in the study protocol
- Antiretroviral naive. Participants who have taken antiretrovirals for postexposure prophylaxis are eligible for this study.
- Able to swallow tablets or capsules
- Willing to use acceptable forms of contraception
Key exclusion criteria (8 listed)
- Physician unable to design a potentially effective HAART regimen based on results of genotypic resistance testing
- Two CD4 counts of less than 350 cells/mm3 obtained at least 7 days apart within 30 days of study entry
- Viral load less than 5,000 copies/ml within 30 days of study entry in participants who have been infected with HIV-1 for more than six months prior to study entry
- Use of systemic cancer chemotherapy, systemic investigational agents, specific antiretroviral medications, or immunomodulators (growth factors, systemic corticosteroids, HIV vaccines, immune globulin, interleukins, interferons) within 30 days prior to study entry
- Current alcohol or drug use that, in the opinion of the investigator, would interfere with the study
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 |
|---|---|---|
| Highly active antiretroviral therapy (HAART)Regimens will be assigned by investigators | Drug | Immediate Treatment Arm |
Primary outcome
Total Treatment-free Time to Initiation of Permanent HAART
Time frame: Through study completion, an average of 18 months
All HAART-free time from initial infection with HIV to initiation of permanent HAART
1 secondary outcome
Toxicity as Assessed by the of Number of Participants With Serious Adverse Events
Time frame: Throughout study completion, an average of 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26600459Margolick JB, Apuzzo L, Singer J, Wong H, Lee T, Gallant JE, El-Helou P, Loutfy MR, Rachlis A, Fraser C, Kasper K, Tremblay C, Tossonian H, Conway B. A Randomized Trial of Time-Limited Antiretroviral Therapy in Acute/Early HIV Infection. PLoS One. 2015 Nov 24;10(11):e0143259. doi: 10.1371/journal.pone.0143259. eCollection 2015.
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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 B. Margolick, MD, PhD principal investigator
Johns Hopkins University
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Highly active antiretroviral therapy (HAART) in people with HIV Infections, run by Johns Hopkins Bloomberg School of Public Health at 5 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 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2023). 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?
Total Treatment-free Time to Initiation of Permanent HAART (time frame: Through study completion, an average of 18 months). 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 NCT00106171, which also lists 1 linked publication.
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 13 Sep 2023.