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Home > "A" Clinical Trials Conditions > A Study of DAPD Alone Versus DAPD Plus MMF for Treatment of HIV Infection  A Study of DAPD Alone Versus DAPD Plus MMF for Treatment of HIV Infection
A Study of DAPD Alone Versus DAPD Plus MMF for Treatment of HIV Infection
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: The antiretroviral potency of DAPD varies among antiretroviral-experienced patients. In vitro studies indicate that the potency of DAPD can be markedly increased by the addition of MMF. Preliminary data indicate that MMF is well tolerated in patients with advanced HIV-1 disease. However, there is currently no clinical data on the activity of DAPD combined with MMF. This study will be the first to evaluate the addition of DAPD and MMF to a patient's current antiretroviral therapy. At study entry, patients are randomized to 1 of 2 blinded treatment arms. Arm A receives DAPD plus MMF placebo in addition to their current regimen, while Arm B receives DAPD plus MMF in addition to their current regimen. The first 32 patients enrolled will undergo an 8-hour intensive pharmacokinetic analysis at Week 2. All patients remain on their current antiretroviral regimen through Week 2. After Week 2, patients who respond virologically are encouraged to remain on blinded study treatment through Week 24. Patients who do not respond virologically are unblinded. After unblinding, patients who were not receiving MMF may add it to their antiretroviral regimen. Response to the addition of open-label MMF is assessed after 2 weeks. Resistance to antiretroviral agents, including DAPD, will be assessed following any virologic failure occuring after Week 2. All patients have the option of optimizing their background antiretroviral regimen at Week 2, based on the results of a pre-entry resistance assay. Patients who are still receiving DAPD alone or DAPD plus MMF at Week 48 and who are still responding virologically may choose to continue the study drug(s) and be followed for up to an additional 48 weeks. Throughout the study, HIV-1 RNA levels, CD4 cell counts, and study drug levels are monitored regularly. Eye exams are done at several study visits. Only DAPD, MMF, and MMF placebo are supplied by this study. Patients must obtain the rest of their treatment regimen through their doctor.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - 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 greater 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. - Acceptable methods of contraception Exclusion Criteria - Pregnant or breast-feeding - 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 - Drugs or alcohol in a way that would interfere with adherence to study requirements
Total Enrollment: 56
Location and Contact Information:
Overall Study Official:
DavidMargolis, Study Chair,
Univ of Colorado Health Sciences Ctr *Recruiting*
Denver, Colorado, 80262
United States
Recruiting M Ray 303-372-5535
Univ of California, Davis Med Ctr *Recruiting*
Sacramento, California, 95814
United States
Recruiting Susan Hulse 916-734-8637
UCLA School of Medicine *Recruiting*
Los Angeles, California, 90095-1793
United States
Recruiting Susan McCarthy 310-206-8029
Univ of Hawaii *Recruiting*
Honolulu, Hawaii, 96816
United States
Recruiting Debra Ogata-Arakaki 808-737-2751
Univ of Texas Galveston *Recruiting*
Galveston, Texas, 775550435
United States
Recruiting Carrie Derkowski 409-747-0241
Stanford Univ Med Ctr *Recruiting*
Stanford, California, 943055107
United States
Recruiting Debbie Slamowitz 650-723-2804
University of Washington (Seattle) *Recruiting*
Seattle, Washington, 98104
United States
Recruiting Jeanne Conley 206-731-8877
Bellevue Hosp / New York Univ Med Ctr *Recruiting*
New York City, New York, 10016
United States
Recruiting Maura Laverty 212-263-6565
Univ of Pennsylvania, Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Joseph Quinn 215-349-8092
Presbyterian Med Ctr - Univ of PA *Recruiting*
Norristown, Pennsylvania, 19401
United States
Recruiting Maureen O'Connell 215-349-8092
Univ of Texas, Southwestern Med Ctr *Recruiting*
Dallas, Texas, 75235-9173
United States
Recruiting Chip Lohner 214-590-0414
Beth Israel Med Ctr *Recruiting*
New York City, New York, 10003
United States
Recruiting Ann Marshak 212-420-4432
UC Davis Med Ctr, CARES Clinic *Recruiting*
Sacramento, California, 95814
United States
Recruiting Susan Hulse 916-734-8637
Univ of Minnesota *Recruiting*
Minneapolis, Minnesota, 55455-0392
United States
Recruiting Christine Fietzer 612-625-1462
Univ of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Christine Tripoli 412-647-0771
Case Western Reserve Univ *Recruiting*
Cleveland, Ohio, 44106-5083
United States
Recruiting Michael Chance 216-844-8051
Univ of Miami *Recruiting*
Miami, Florida, 33136-1013
United States
Recruiting Leslie Thompson 305-243-3838
Additional Information:
Study ID Numbers: ACTG A5165; AACTG A5165
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038272
Other Hiv Infections Studies:
1. A Study to Evaluate the Effects of Anti-HIV Drugs in HIV-Positive Patients Who Also Have Hepatitis C Infection
2. Safety of the Candidate Vaccine C4-V3 Alone or with Interleukin-12 (IL-12) in HIV-Infected Patients Receiving Effective Anti-HIV Drug Therapy
3. Study of How Indinavir (an Anti-HIV Drug) and Rifabutin (a Drug Used to Treat MAC, an HIV-Associated Disease) Interact in HIV-Positive and HIV-Negative Adults
4. A Phase II Dose-Ranging, Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure
5. A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other Sacramento Clinical Trials
A Study of DAPD Alone Versus DAPD Plus MMF for Treatment of HIV Infection
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