Phase 4
N=113
Anti-HIV Medications for People Recently Infected With HIV
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00106171 ↗Enrolled (actual)
113
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Total Treatment-free Time to Initiation of Permanent HAART — 18; 18 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Highly active antiretroviral therapy (HAART) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Treatment-free Time to Initiation of Permanent HAART |
18; 18 | — |
| SECONDARY Toxicity as Assessed by the of Number of Participants With Serious Adverse Events |
0; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00106171). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.