Addition of cyclophosphamide to antiretroviral therapy does not diminish the cellular reservoir in HIV-infected persons.
John A Bartlett, G Diego Miralles, Anne D Sevin...
https://pubmed.ncbi.nlm.nih.gov/12036483Completed
Phase 1
Age: 18Years - 50Years
All Genders
ID00000899
Effect of Cytoreductive Chemotherapy Combined With Highly Active Antiretroviral Therapy on Lymph Node HIV DNA in HIV-Infected Subjects
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-29
10
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study on the Effect of Chemotherapy Combined With Anti-HIV Drugs in HIV-Positive Patients
Who Can Participate
Age: 18Years - 50Years
All Genders
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 2 locations
1
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
Status Unknown
2
Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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