Anti-HIV Medications for People Recently Infected With HIV
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Highly active antiretroviral therapy (HAART) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Trial of HAART in Acute/Early HIV Infection |
- Comparison of the plasma viral load in all treated vs. untreated patients [ Time Frame: At Month 24 ] [ Designated as safety issue: No ]
- Comparison of the plasma viral load in all treated vs. untreated patients [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
- Comparison of the CD4 lymphocyte count in all treated vs. untreated patients [ Time Frame: At Months 24 and 36 ] [ Designated as safety issue: No ]
- Comparison of the plasma viral load in patients treated in the acute vs. early stage of infection [ Time Frame: At Months 24 and 36 ] [ Designated as safety issue: No ]
- Comparison of the CD4 lymphocyte count in patients treated in the acute vs. early stage of infection [ Time Frame: At Months 24 and 36 ] [ Designated as safety issue: No ]
- Toxicity of HAART in all treated patients [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 180 |
| Study Start Date: | February 2005 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants will receive HAART for 1 year
|
Drug: Highly active antiretroviral therapy (HAART)
Regimens will be assigned by investigators
|
|
No Intervention: 2
Participants will receive no treatment
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00106171
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21205 | |
| Canada, British Columbia | |
| University of British Columbia | |
| Vancouver, British Columbia, Canada, V6Z2C7 | |
| Canada, Ontario | |
| Canadian Immunodeficiency Research Collaborative (CIRC) Inc. | |
| Toronto, Ontario, Canada, M5B IL6 | |
| Sunnybrook Health Sciences Ctr. | |
| Toronto, Ontario, Canada, M4N 3M5 CA | |
| Canada, Quebec | |
| CHUM - Hotel-Dieu | |
| Montreal, Quebec, Canada, H2W 1T8 CA | |
| Principal Investigator: | Joseph B. Margolick, MD, PhD | Johns Hopkins University |
More Information
Additional Information:
Publications:
| Responsible Party: | Joseph B. Margolick, MD, PhD, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00106171 History of Changes |
| Other Study ID Numbers: | 1R01AI056990-01A1, 1R01-AI056990-01A1 |
| Study First Received: | March 21, 2005 |
| Last Updated: | February 17, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
HIV Acute/Early Seroconverters Acute Infection Treatment Naive Primary HIV Infection |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome Communicable Diseases HIV Infections Infection Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections |
RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases |
ClinicalTrials.gov processed this record on February 26, 2015