Safety and Effectiveness of an Anti-HIV Drug Combination With and Without Hydroxyurea in Patients With Early HIV Infection

NCT00006339 | Withdrawn Phase 2

• 6 other identifiers: AI-03-00111508AIEDRP AI-03-001Substudy AI-03-002Substudy AI-03-003Substudy AI-03-004
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the safety and effectiveness of an anti-HIV drug combination with and without hydroxyurea in patients with early HIV infection. Certain combinations of anti-HIV drugs have been effective in lowering levels of HIV in the blood and keeping them down. However, these treatments are not effective in some patients. This study will see if using a combination containing more drugs will help in patients with early HIV infection.

Conditions

HIV Infections

Keywords

Prospective Studies; HIV-1; Didanosine; Drug Therapy, Combination; Stavudine; HIV Protease Inhibitors; Hydroxyurea; Ritonavir; Indinavir; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Viral Load; Reverse Transcriptase Polymerase Chain Reaction

Interventions

Indinavir sulfate DRUG

Ritonavir DRUG

Hydroxyurea DRUG

Stavudine 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:

• Patient may be eligible if they:
• Are in the early stages of HIV infection.
• Are at least 13 years old (consent of parent or guardian required if under 18).
• Agree to use 2 barrier methods of birth control (such as condoms) during the study and for 3 months after.

You may not qualify if:

• Patients will not be eligible if they:
• Have a liver or kidney problem (Group I only).
• Have a history of pancreatitis (Group I only).
• Have ever taken anti-HIV drugs before.
• Plan to take anti-HIV drugs other than the study drugs during the study. (Study drugs may be substituted if the investigator finds it necessary.)
• Have had radiation treatment within 30 days prior to study entry.
• Have received chemotherapy or any experimental therapy within 30 days of study entry or plan to receive such therapies during the study.
• Have taken interferons, interleukins, colony-stimulating factors, and HIV vaccines within 30 days prior to study entry.
• Have taken certain other drugs.
• Are pregnant or breast-feeding.

Sponsors & Collaborators

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

MeSH Terms

Conditions

HIV Infections

Interventions

Indinavir; Ritonavir; Hydroxyurea; Stavudine; 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)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Urea; Amides; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Inosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ribonucleosides

Study Officials

• Robert Schooley

  STUDY CHAIR

• Wheaton Williams

  STUDY CHAIR

• Dan Kuritzkes

  STUDY CHAIR

• Elizabeth Connick

  STUDY CHAIR

• Constance Benson

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: October 4, 2000
• First Posted: August 31, 2001
• Last Updated: November 1, 2021

Record last verified: 2021-10