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

NCT00000899 | Completed Phase 1

• 2 other identifiers: ACTG 38011341
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

HIV Infections

Keywords

Cyclophosphamide; Dose-Response Relationship, Drug; Drug Therapy, Combination; Granulocyte Colony-Stimulating Factor; Combined Modality Therapy; Antineoplastic Agents; Lymph Nodes; Stavudine; HIV Protease Inhibitors; Lamivudine; DNA, Viral; RNA, Viral; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Nelfinavir; Antineoplastic Agents, Alkylating

Interventions

Nelfinavir mesylate DRUG

Lamivudine DRUG

Filgrastim DRUG

Stavudine DRUG

Cyclophosphamide DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

Univ of North Carolina

Chapel Hill, North Carolina, 275997215, United States

Location

Duke Univ Med Ctr

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

• Bartlett JA, Silberman M, Miralles GD, Sevin A, Pruitt S, Ottinger J, Gryszowka V, Fiscus S, Bucy BP. Antiretroviral therapy (ART) plus cyclophosphamide (CTX) to diminish HIV DNA in lymphoid tissue. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 16)

  BACKGROUND

• Bartlett JA, Miralles GD, Sevin AD, Silberman M, Pruitt SK, Ottinger J, Gryszowska V, Fiscus SA, Bucy RP; ACTG 380 Study Team. Addition of cyclophosphamide to antiretroviral therapy does not diminish the cellular reservoir in HIV-infected persons. AIDS Res Hum Retroviruses. 2002 May 20;18(8):535-43. doi: 10.1089/088922202753747888.

  PMID: 12036483 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Nelfinavir; Lamivudine; Filgrastim; Stavudine; Cyclophosphamide

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)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Thymidine; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• John A. Bartlett, MD

  Duke Univ Med Ctr

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: October 1, 2001
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

US (2)