N/A
N=16
Safety and Effectiveness of Short-Term Anti-HIV Drug Therapy for Recent HIV-1 Infection
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00414518 ↗Enrolled (actual)
16
Serious AEs
12.5%
Results posted
Feb 2013
Primary outcome: Primary: Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms — 4.8627; 4.2620 Log 10 copies of virus/ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tenofovir disoproxil fumarate/Emtricitabine (Drug); Lopinavir/Ritonavir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms |
4.8627; 4.2620 | — |
| PRIMARY Number of Participants Experiencing Either an AIDS-defining Event, a Grade 3 or 4 Adverse Event, or Acute Retroviral Syndrome |
1; 1 | — |
| PRIMARY Viral Set Point |
4.8627; 4.2434 | — |
Summary
The purpose of this study is to determine the safety and effectiveness of an anti-HIV drug regimen followed by treatment interruption in people recently infected with HIV. This study will also compare the effects of a treatment regimen including treatment interruption with a treatment plan based on clinical indicators.
Eligibility Criteria
Inclusion Criteria
- Acute or recent HIV-1 infection. More information about this criterion can be found in the protocol.
- CD4 count 500 cells/mm3 or greater
- No evidence of prior or current AIDS-defining illness
- No signs or symptoms of HIV infection or AIDS-defining illness that, in the opinion of the investigator, requires ART
- Willing to use acceptable forms of contraception
Exclusion Criteria
- Prior treatment with any antiretroviral drug for more than 7 days
- Use of certain drugs within 21 days of study entry
- Prior receipt of investigational anti-HIV-1 vaccine
- Ongoing therapy with systemic corticosteroids, chemotherapeutic agents, nephrotoxic systemic agents, immunomodulatory treatments, or investigational agents
- Known allergy/sensitivity to study drugs or their formulations
- Current drug or alcohol use or abuse that, in the opinion of the investigator, may interfere with the study
- Serious medical or psychiatric illness that may interfere with the study
- Hepatitis B infected
- Pregnancy or breastfeeding
Data sourced from ClinicalTrials.gov (NCT00414518). 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.