HIV Infections
Conditions
Keywords
HIV, Acute/Early Seroconverters, Acute Infection, Treatment Naive, Primary HIV Infection
Brief 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. 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.
Interventions
Regimens will be assigned by investigators
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Treatment-free Time to Initiation of Permanent HAART | Through study completion, an average of 18 months | All HAART-free time from initial infection with HIV to initiation of permanent HAART |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity as Assessed by the of Number of Participants With Serious Adverse Events | Throughout study completion, an average of 18 months | Number of participants with serious adverse events (grade 3 or 4 as defined by the NIH toxicity scale) |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Immediate Treatment Arm Participants will receive HAART for 1 year
Highly active antiretroviral therapy (HAART): Regimens will be assigned by investigators | 57 |
| Deferred Treatment Arm Participants will receive no treatment | 56 |
| Total | 113 |
Baseline characteristics
| Characteristic | Deferred Treatment Arm | Total | Immediate Treatment Arm |
|---|---|---|---|
| Age, Continuous | 32.8 years | 33.2 years | 34.7 years |
| Region of Enrollment Canada | 30 Participants | 57 Participants | 27 Participants |
| Region of Enrollment United States | 26 Participants | 56 Participants | 30 Participants |
| Sex: Female, Male Female | 9 Participants | 14 Participants | 5 Participants |
| Sex: Female, Male Male | 47 Participants | 99 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 56 |
| other Total, other adverse events | 0 / 57 | 0 / 56 |
| serious Total, serious adverse events | 0 / 57 | 0 / 56 |
Outcome results
Primary
Total Treatment-free Time to Initiation of Permanent HAART
All HAART-free time from initial infection with HIV to initiation of permanent HAART
Time frame: Through study completion, an average of 18 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Immediate Treatment Arm | Total Treatment-free Time to Initiation of Permanent HAART | 18 months |
| Deferred Treatment Arm | Total Treatment-free Time to Initiation of Permanent HAART | 18 months |
Secondary
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)
Time frame: Throughout study completion, an average of 18 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate Treatment Arm | Toxicity as Assessed by the of Number of Participants With Serious Adverse Events | 0 Participants |
| Deferred Treatment Arm | Toxicity as Assessed by the of Number of Participants With Serious Adverse Events | 0 Participants |