Anti-HIV Medications for People Recently Infected With HIV

HIV Infections Clinical Trial

Official title:

A Randomized Trial of HAART in Acute/Early HIV Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00106171
• Other study ID #: 1R01AI056990-01A1
• Secondary ID: 1R01AI056990-01A
• Status: Completed
• Phase: Phase 4
• Start date: May 2005
• Est. completion date: May 2012

Study information

• Verified date: August 2023
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Study hypothesis: A one-year course of HAART administered during acute or early seroconversion may slow the progression of HIV infection.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Infections

Intervention

Drug:
• Highly active antiretroviral therapy (HAART)
Regimens will be assigned by investigators

Locations

Country	Name	City	State
Canada	CHUM - Hotel-Dieu	Montreal	Quebec
Canada	Canadian Immunodeficiency Research Collaborative (CIRC) Inc.	Toronto	Ontario
Canada	Sunnybrook Health Sciences Ctr.	Toronto	Ontario
Canada	University of British Columbia	Vancouver	British Columbia
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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 No — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Treatment-free Time to Initiation of Permanent HAART	All HAART-free time from initial infection with HIV to initiation of permanent HAART	Through study completion, an average of 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)	Throughout study completion, an average of 18 months