A Study of DAPD Alone Versus DAPD Plus MMF for Treatment of HIV Infection
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Placebos, Drug Therapy, Combination, Anti-HIV Agents, Mycophenolate Mofetil, 2,6-diaminopurine dioxolane, Treatment Experienced, DAPD, MMF
Eligibility Criteria
Inclusion Criteria for Step 1: HIV infected Triple-class antiretroviral treatment, as determined by the site investigator and as defined by all of the following: a) exposure to 2 or more nucleotide reverse transcriptase inhibitors (NRTIs) for at least 3 months each; b) exposure to 2 or more non-boosted protease inhibitors (PIs) for at least 3 months each, or exposure to a dual PI regimen for at least 3 months; and c) exposure to at least 1 non-nucleotide reverse transcriptase inhibitor (NNRTI) for at least 3 months. CD4 cell count of at least 50 cells/mm3 within 45 days prior to study entry Viral load of 2000 copies/ml or more within 45 days prior to study entry On current antiretroviral treatment regimen for at least 30 days prior to study entry. If current treatment includes abacavir, abacavir must be discontinued at least 30 days prior to study entry. Willing to use acceptable methods of contraception Exclusion Criteria for Step 1: Pregnant or breastfeeding Allergy or sensitivity to the study drugs and their formulations Diabetes mellitus Cataracts or any measurable loss of vision due to lens opacity Best-corrected visual acuity worse than 20/200 Certain drugs or vaccines within 30 days prior to study entry History of any of the following: kidney disease; serious illness within 14 days prior to study entry; end organ cytomegalovirus infection; Kaposi's sarcoma; cataracts; active herpetic infection or peptic ulcer disease within 12 months; or malabsorption, severe chronic diarrhea, or inability to eat 1 or more meals a day because of chronic nausea, emesis, or abdominal/mouth and throat discomfort Current alcohol or drug abuse that would interfere with adherence to study requirements
Sites / Locations
- UCLA CARE Center CRS
- Stanford CRS
- UC Davis Medical Center
- Univ. of California Davis Med. Ctr., ACTU
- University of Colorado Hospital CRS
- Univ. of Miami AIDS CRS
- Univ. of Hawaii at Manoa, Leahi Hosp.
- Johns Hopkins Adult AIDS CRS
- University of Minnesota, ACTU
- Washington U CRS
- Beth Israel Med. Ctr., ACTU
- NY Univ. HIV/AIDS CRS
- Case CRS
- Hosp. of the Univ. of Pennsylvania CRS
- Univ. of Pennsylvania Health System, Presbyterian Med. Ctr.
- Pitt CRS
- University of Washington AIDS CRS