Overview

A Study of DAPD Alone Versus DAPD Plus MMF for Treatment of HIV Infection

Status:
Completed
Trial end date:
2006-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
2,6-diaminopurine
Mycophenolate mofetil
Mycophenolic Acid
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