A Study on the Effect of Chemotherapy Combined With Anti-HIV Drugs in HIV-Positive Patients

• Status: Completed
• Trial end date: 2001-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety of anti-HIV drugs combined with low-dose chemotherapy (consisting of cyclophosphamide [CTX]) in HIV-positive patients. This study examines whether this combination therapy can reduce the number of HIV-infected cells hidden in the lymph nodes and blood.

Current anti-HIV drug treatments can greatly reduce the levels of HIV in the human body. However, HIV can hide in certain immune cells and escape the drugs' effects. Chemotherapy using CTX destroys these immune cells. When used with standard anti-HIV drug treatments, CTX may be able to speed up the elimination of HIV-infected cells.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Antineoplastic Agents; Antineoplastic Agents, Alkylating; Cyclophosphamide; Lamivudine; Nelfinavir; Stavudine

Criteria

Inclusion Criteria

You may be eligible for this study if you:

• Are HIV-positive.

• Have a CD4 count above 300 cells/mm3 within 30 days of study entry.

• Have an HIV viral load between 10,000 and 200,000 copies/ml.

• Are between the ages of 18 and 50.

• Agree to practice abstinence or to use a barrier method of birth control during the study (such as condoms).

Exclusion Criteria

You may not be eligible for this study if you:

• Have had cancer requiring chemotherapy or radiotherapy or certain nervous system diseases.

• Are sensitive to E. coli-derived proteins.

• Have an active AIDS-defining illness.

• Require certain medications.

• Are pregnant or breast-feeding.