Mycophenolate Mofetil and Abacavir Treatment in HIV Patients With Failed Anti-HIV Treatment

NCT00021489 | Withdrawn Phase 2

• 5 other identifiers: A510510927ACTG A5105AACTG A5105Substudy AACTG A5121s
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to learn how safe and well-tolerated mycophenolate mofetil (MMF) is when given with abacavir (ABC). Another purpose is to see if adding MMF to ABC decreases viral load (amount of HIV in the blood) more than ABC alone. Many HIV-infected patients who have had heavy exposure to anti-HIV drugs and have experienced treatment failure need new treatment combinations. One promising combination is ABC and MMF as part of a drug combination. Laboratory studies show that MMF helps ABC destroy HIV in the cells and further clinical testing is needed. MMF is not FDA-approved as a treatment for HIV infection but has been approved by FDA to prevent rejection of organ transplants. Doses of MMF tested in this study will be lower than those used to treat people with organ transplants.

Conditions

HIV Infections

Keywords

Placebos; Drug Therapy, Combination; Reverse Transcriptase Inhibitors; Anti-HIV Agents; abacavir; mycophenolate mofetil

Interventions

Abacavir sulfate DRUG

Mycophenolate mofetil DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients may be eligible for this study if they:
• Are HIV infected.
• Have a CD4 cell count of at least 100 cells/microL.
• Have a viral load (amount of virus in the blood) of at least 2,000 copies/ml obtained within 30 days prior to study entry.
• Have had exposure to all 3 classes of anti-HIV drugs (2 or more NRTIs for at least 12 months each, 2 or more PIs for at least 6 months each, and 1 or more NNRTIs for at least 3 months).
• Have not changed an NNRTI or PI in their anti-HIV drugs in the 30 days prior to study entry.
• Have a negative pregnancy test within 7 days prior to study entry.
• Agree to use 2 accepted birth control methods while on the study and for 6 weeks after stopping the drugs, if participating in sexual activity that could lead to pregnancy.
• Are at least 13 years of age.
• Have consent of parent or guardian if under 18 years of age.
• Start preventive treatment for Pneumocystis carinii pneumonia (PCP) within 30 days prior to study entry, if CD4 cell count is below 200 cells/microL.

You may not qualify if:

• Patients will not be eligible for this study if they:
• Use ABC, hydroxyurea, metronidazole, MMF, or ribavirin within 30 days prior to study entry.
• Are allergic to ABC or MMF.
• Have had prior CMV infection in any organs.
• Have had Kaposi's sarcoma.
• Have had a herpes infection within 3 months prior to study entry, or have had more than 3 outbreaks of herpes in a year, or have had more than 1 outbreak of herpes despite preventive treatment.
• Have had ulcers within 1 year of entering the study.
• Abuse alcohol or drugs.
• Are breast-feeding.
• Use certain drugs that may interfere with the study within 30 days prior to study entry.
• Have a serious illness that may interfere with their entering the study.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

MeSH Terms

Conditions

HIV Infections

Interventions

abacavir; Mycophenolic Acid

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• David Margolis

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2001
• First Posted: August 31, 2001
• Last Updated: November 1, 2021

Record last verified: 2021-10