Effectiveness of Early or Delayed Addition of Hydroxyurea to a Three-Drug Anti-HIV Drug Combination Including Didanosine, in Advanced HIV Patients Who Failed a First or Second Anti-HIV Triple-Drug Therapy

NCT00008866 | Withdrawn Phase 2

• 5 other identifiers: A506910905ACTG A5069AACTG A5069Substudy AACTG A5070s
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to find out whether or not the addition of hydroxyurea to didanosine (ddI) and other anti-HIV medications will result in better control of HIV infection. The Food and Drug Administration (FDA) has approved ddI for treating HIV infections. Hydroxyurea is approved for treating some cancers and blood disorders. It works against HIV-1 when combined with ddI. Researchers need to look at how well patients may respond to hydroxyurea in combination with ddI and other anti-HIV drugs, and at any side effects.

Conditions

HIV Infections

Keywords

HIV-1; Didanosine; Drug Therapy, Combination; Drug Administration Schedule; CD4-Positive T-Lymphocytes; Hydroxyurea; RNA, Viral; Genotype; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Viral Load

Interventions

Tetanus Toxoid Vaccine BIOLOGICAL

Hydroxyurea DRUG

Didanosine 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 at least 13 years old.
• Have the signed consent of parent/guardian if under 18 years of age.
• Are HIV-positive.
• Have failed 1 or 2 anti-HIV drug combination therapies which had at least 3 anti-HIV drugs each.
• Have been on stable, triple anti-HIV drug therapy for at least 16 weeks prior to study entry.
• Have a CD4 count under 300 cells/mm3 within 45 days prior to study entry.
• Agree not to become pregnant or make anyone else pregnant while on study drugs and for 60 days after stopping drugs.
• Agree to use 2 methods of birth control while on study drugs and for 60 days after stopping study drugs.
• Have a negative pregnancy test within 14 days prior to study entry.

You may not qualify if:

• Patients will not be eligible for this study if they:
• Received treatment for a serious infection or illness that was completed less than 2 weeks prior to study entry or, if they are still receiving treatment, he/she must have been clinically stable for at least 14 days prior to study entry.
• Are pregnant or breast-feeding.
• Are using any drugs that affect the immune system, other than those specified by the study.
• Received an immunization within 30 days prior to study entry.
• Have had pancreatitis.
• Have severe neuropathy (a condition affecting the nervous system).
• Received granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days prior to study entry.
• Abuse alcohol or drugs.
• Have any medical condition that would make the patient unable to complete the study.
• Have used hydroxyurea within 24 weeks prior to study entry.
• Had hepatitis within 60 days of study entry.

Sponsors & Collaborators

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

MeSH Terms

Conditions

HIV Infections

Interventions

Tetanus Toxoid; Hydroxyurea; Didanosine

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)

Toxoids; Vaccines; Biological Products; Complex Mixtures; Urea; Amides; Organic Chemicals; Inosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• David Asmuth

  STUDY CHAIR

• Judith Feinberg

  STUDY CHAIR

• Richard Pollard

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

Record last verified: 2021-10