Washington,
District of Columbia
20007
Purpose:
The purpose of this study is to determine whether patients who have asymptomatic HIV
infection can discontinue antiretroviral therapy (ART) without adverse clinical, virologic,
or immunologic consequences. This study will also assess the virologic, immunologic, and
clinical outcomes in any patients who restart ART.
Study summary:
Patients who can discontinue ART without a significant loss of virologic or immunologic
control and without an increase in clinical events may be spared the expense and adverse
effects of treatment. However, the consequences of treatment discontinuation in patients
with asymptomatic HIV infections are not well understood. This study will follow the
clinical and immunologic progression of HIV infection in patients who have low HIV viral
load and preserved CD4+ cell counts at the time ART is stopped.
Patients will fast for at least 8 hours prior to the first study visit. At this visit, blood
will be drawn and body measurements will be taken. Patients will then discontinue their ART.
Patients taking nonnucleoside reverse transcriptase inhibitors (NNRTIs) will stop taking
NNRTIs 48 hours before withdrawing their other ART drugs. Study visits will occur every 4 to
8 weeks for the first year, then every 12 weeks for the second year. Blood will be taken at
most visits, and patients will be asked to fast for at least 8 hours prior to Week 12 and 24
visits and again every 6 months. Patients who reinitiate ART for any reason will be
registered to Step 2 and followed for 24 weeks.
Criteria:
Inclusion Criteria:
- HIV infection
- ART with 2 or more drugs for 6 or more months
- CD4+ cell count(s) > 350 cells/mm3 immediately prior to initiation of first ART
- CD4+ cell count > 350 cells/mm3 within 45 days prior to study entry
- Plasma viral load < 55,000 copies/ml within 45 days prior to study entry
- Willingness to discontinue ART at study entry
- Negative serum or urine pregnancy test within 14 days prior to study entry
Exclusion Criteria:
- Pregnancy or breast-feeding
- Systemic cancer chemotherapy, systemic investigational agents, or immunomodulators
within 30 days prior to study entry
- Drug or alcohol use or dependence that would interfere with adherence to study
requirements
- Illness requiring systemic treatment and/or hospitalization until the patient either
completes therapy or has been clinically stable on therapy for at least 30 days prior
to study entry
- Chronic medical condition that would have a negative impact on the participation of
the patient or would be expected to result in significant use of the medical care
system
- History of an HIV-related illness or complication in CDC categories B and C
- Nonadherence to ART
- Active infection with hepatitis B and currently taking adefovir at doses > 10 mg or
3TC and/or TDF