Anti-HIV Medications for People Recently Infected With HIV

NCT00106171 | Completed Phase 4 Results

• 1 other identifier: 1R01AI056990-01A1
• Study Type: interventional
• Target: 113
• Locations: 2 countries
• Sites: 5

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.

Conditions

HIV Infections

Keywords

HIV; Acute/Early Seroconverters; Acute Infection; Treatment Naive; Primary HIV Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Toxicity as Assessed by the of Number of Participants With Serious Adverse Events

  Throughout study completion, an average of 18 months

Study Arms (2)

Immediate Treatment Arm

EXPERIMENTAL

Participants will receive immediate HAART for 1 year; then HAART will stopped until clinically indicated.

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.

Interventions

Highly active antiretroviral therapy (HAART) DRUG

Regimens will be assigned by investigators

Immediate Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (5)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

University of British Columbia

Vancouver, British Columbia, V6Z2C7, Canada

Location

Sunnybrook Health Sciences Ctr.

Toronto, Ontario, M4N 3M5 CA, Canada

Location

Canadian Immunodeficiency Research Collaborative (CIRC) Inc.

Toronto, Ontario, M5B IL6, Canada

Location

CHUM - Hotel-Dieu

Montreal, Quebec, H2W 1T8 CA, Canada

Location

Related 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 Nov 24;10(11):e0143259. doi: 10.1371/journal.pone.0143259. eCollection 2015.

  PMID: 26600459 RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Antiretroviral Therapy, Highly Active

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Joseph Margolick
• Organization: Johns Hopkins University

jmargoli@jhsph.edu

410-955-1436

Study Officials

• Joseph B. Margolick, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2005
• First Posted: March 22, 2005
• Study Start: May 1, 2005
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: September 13, 2023
• Results First Posted: September 13, 2023

Record last verified: 2023-08

Locations

US (1); CA (4)