A Study of DAPD Alone Versus DAPD Plus MMF for Treatment of HIV Infection
A Phase I/II Randomized, Double-Blind, Placebo-Controlled Pilot Study of Beta-D-2,6-diaminopurine Dioxolane (DAPD) Versus DAPD Plus Mycophenolate Mofetil (MMF) in Treatment-Experienced Subjects
4 other identifiers
interventional
56
1 country
17
Brief Summary
The purpose of this study is to evaluate the safety, efficacy, and side effects of beta-D-2,6-diaminopurine dioxolane (DAPD) compared to DAPD plus mycophenolate mofetil (MMF) when these drugs are added to the anti-HIV treatment regimens of people infected with HIV. Some studies have shown that DAPD and MMF can help fight HIV. However, neither DAPD nor MMF has been approved by the Food and Drug Administration for treating HIV infection. This study will help doctors decide if DAPD and MMF are good drugs for treating HIV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hiv-infections
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2002
CompletedFirst Posted
Study publicly available on registry
May 30, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedNovember 1, 2021
October 1, 2021
May 29, 2002
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
UCLA CARE Center CRS
Los Angeles, California, 90095-1793, United States
Stanford CRS
Palo Alto, California, 943055107, United States
UC Davis Medical Center
Sacramento, California, 95814, United States
Univ. of California Davis Med. Ctr., ACTU
Sacramento, California, 95814, United States
University of Colorado Hospital CRS
Aurora, Colorado, 80262, United States
Univ. of Miami AIDS CRS
Miami, Florida, 33136-1013, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States
University of Minnesota, ACTU
Minneapolis, Minnesota, 55455-0392, United States
Washington U CRS
St Louis, Missouri, 63108-2138, United States
Beth Israel Med. Ctr., ACTU
New York, New York, 10003, United States
NY Univ. HIV/AIDS CRS
New York, New York, 10016, United States
Case CRS
Cleveland, Ohio, 44106-5083, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104, United States
Univ. of Pennsylvania Health System, Presbyterian Med. Ctr.
Philadelphia, Pennsylvania, 19401, United States
Pitt CRS
Pittsburgh, Pennsylvania, 15213, United States
University of Washington AIDS CRS
Seattle, Washington, 98104, United States
Related Publications (4)
Chapuis AG, Paolo Rizzardi G, D'Agostino C, Attinger A, Knabenhans C, Fleury S, Acha-Orbea H, Pantaleo G. Effects of mycophenolic acid on human immunodeficiency virus infection in vitro and in vivo. Nat Med. 2000 Jul;6(7):762-8. doi: 10.1038/77489.
PMID: 10888924BACKGROUNDCoull JJ, Turner D, Melby T, Betts MR, Lanier R, Margolis DM. A pilot study of the use of mycophenolate mofetil as a component of therapy for multidrug-resistant HIV-1 infection. J Acquir Immune Defic Syndr. 2001 Apr 15;26(5):423-34. doi: 10.1097/00126334-200104150-00004.
PMID: 11391161BACKGROUNDGulick RM. New antiretroviral drugs. Clin Microbiol Infect. 2003 Mar;9(3):186-93. doi: 10.1046/j.1469-0691.2003.00570.x.
PMID: 12667250BACKGROUNDRizzardi GP, Lazzarin A, Pantaleo G. Potential role of immune modulation in the effective long-term control of HIV-1 infection. J Biol Regul Homeost Agents. 2002 Jan-Mar;16(1):83-90.
PMID: 12003181BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
David Margolis, MD
Division of Infectious Diseases, University of Texas Southwestern Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2002
First Posted
May 30, 2002
Study Completion
April 1, 2006
Last Updated
November 1, 2021
Record last verified: 2021-10