Phase 4
N=4,688
Strategic Timing of Antiretroviral Treatment
HIV Infection
Bottom Line
View on ClinicalTrials.gov: NCT00867048 ↗Enrolled (actual)
4,688
Serious AEs
19.8%
Results posted
Dec 2023
Primary outcome: Primary: Composite Endpoint of AIDS, Serious Non-AIDS Diagnoses, and All-cause Mortality — 133; 215 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- All licensed antiretroviral medications (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Endpoint of AIDS, Serious Non-AIDS Diagnoses, and All-cause Mortality |
133; 215 | — |
| SECONDARY AIDs or AIDs Related Death |
31; 83 | — |
| SECONDARY Specific Non-AIDS Diagnoses |
107; 137 | — |
| SECONDARY Death, All-cause Mortality |
66; 85 | — |
| SECONDARY Quality of Life- Mean Change From Baseline in a Visual Analog Scale (VAS) for Perceived Current Health |
1.8; 0.22 | — |
| SECONDARY Transmission Risk Behavior Outcome 1 |
156; 155 | — |
| SECONDARY Change in Neurocognitive Function (in a Subset of Participants) |
0.19; 0.21 | — |
| SECONDARY Large Artery Elasticity (in a Subset of Participants) |
0.27; 0.8 | — |
| SECONDARY Rate of Lung Function Decline (in a Subset of Participants) Among |
-36.6; -38.8 | — |
| SECONDARY Changes in Bone Mineral Density (in a Subset of Participants) Measure 1 |
-1.8; -0.9 | — |
| SECONDARY Transmission Risk Behavior Outcome 2 |
101; 80 | — |
| SECONDARY Small Artery Elasticity (in a Subset of Participants) |
-0.23; -0.18 | — |
| SECONDARY Rate of Lung Function Decline (in a Subset of Participants) Among Non-smokers |
-26.9; -22.8 | — |
| SECONDARY Changes in Bone Mineral Density (in a Subset of Participants) Measure 2 |
-2.8; -1.7 | — |
Summary
Objectives:
* To find out if the chance of developing a serious illness or of getting AIDS is less if patients start taking HIV medicines at a time when their cluster-of-differentiation-4 (CD4)+ cell count is still fairly high, instead of waiting until the CD4+ count is at the level where there is good evidence for starting medicines.
* To learn more about how a strategy of starting HIV medicines early might affect other aspects of care, such as the chances of developing other illnesses or resistance to HIV medicines, the frequency of doctor visits, the cost of medical care, and general health and satisfaction.
Eligibility Criteria
INCLUSION CRITERIA
- Signed informed consent
- HIV infection documented by a plasma HIV RNA viral load, rapid HIV test or any licensed* ELISA test; and confirmed by another test using a different method including but not limited to a rapid HIV test, Western Blot, HIV culture, HIV antigen, or HIV pro-viral DNA at any time prior to study entry.
- Age greater than or equal to 18 years
- Karnofsky performance score greater than or equal to 80 (an indication that the participant can perform normal activities)
- Perceived life expectancy of at least 6 months
- For women of child-bearing potential, willingness to use contraceptives as described in the product information of the ART drugs they are prescribed
- Two CD4+ cell counts greater than 500 cells/mm(3) at least 2 weeks apart within 60 days before randomization
- The term licensed refers to an FDA-approved kit or, for sites located in countries other than the United States, a kit that has been certified or licensed by an oversight body within that country. Confirmation of the initial test result must use a test method that is different than the one used for the initial assessment.
EXCLUSION CRITERIA
- Any previous use of ART or interleukin-2 (IL-2)
- Diagnosis of any clinical AIDS event before randomization (including esophageal candidiasis and chronic Herpes simplex infection)
- Presence of HIV progression such as oral thrush, unexplained weight loss, or unexplained fever
- Cardiovascular event (myocardial infarction, angioplasty, coronary-artery bypass grafting, stroke) within 6 months before randomization
- Non-AIDS-defining cancer, excluding basal and squamous cell skin cancer, within 6 months before randomization
- Dialysis within 6 months before randomization
- Diagnosis of decompensated liver disease before randomization
- Current imprisonment, or compulsory detention (involuntary incarceration) for treatment of a psychiatric or physical illness
- Current pregnancy or breastfeeding (a negative serum or urine pregnancy test is required within 14 days before randomization for women of child-bearing potential)
Data sourced from ClinicalTrials.gov (NCT00867048). 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.