Clinical trial NCT00106171: Anti-HIV Medications for People Recently Infected With HIV
Official title: A Randomized Trial of HAART in Acute/Early HIV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: HIV
Acute/Early Seroconverters
Acute Infection
Treatment Naive
Primary HIV Infection
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2005-03-22
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Treatment-free Time to Initiation of Permanent HAART
timeFrame: Through study completion, an average of 18 months
Secondary outcomes:
measure: Toxicity as Assessed by the of Number of Participants With Serious Adverse Events
timeFrame: Throughout study completion, an average of 18 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Ctr.
state: Ontario
city: Toronto
country: Canada
facility: Canadian Immunodeficiency Research Collaborative (CIRC) Inc.
state: Ontario
city: Montreal
country: Canada
facility: CHUM - Hotel-Dieu
state: Quebec
Study officials:
affiliation: Johns Hopkins University
name: Joseph B. Margolick, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.