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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006339
Recruitment Status : Withdrawn
First Posted : August 31, 2001
Last Update Posted : May 21, 2012
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Indinavir sulfate Drug: Ritonavir Drug: Hydroxyurea Drug: Stavudine Drug: Didanosine Phase 2

Detailed Description:

Combination antiretroviral therapy including two nucleoside reverse transcriptase inhibitors (NRTIs) and a single HIV-1 protease inhibitor (PI) results in significant and sustained decreases in plasma HIV-1 RNA with a resultant marked diminution in the selection of drug-resistant variants in those able to adhere to and tolerate these regimens. However, two lines of evidence suggest that additional and perhaps more aggressive approaches may be necessary in some HIV-infected individuals: 1) the failure of some potent three-drug regimens to sustain viral replication to levels below the limits of detection; and 2) the ability to recover virus from lymphoid tissue obtained from those without evidence of detectable plasma HIV-1 RNA using the most sensitive assays. A regimen containing more drugs with potentially different mechanisms of action or synergistic activity may result in greater, more rapid, or more durable antiviral activity, or reduce the number of latently infected cells in those patients with acute or early HIV-1 infection.

Patients in Group I begin study therapy within 7 to 14 days of screening. Patients are randomized to 1 of 2 treatment arms. Arm A receives stavudine (d4T) plus didanosine (ddI) plus ritonavir plus indinavir. Arm B receives d4T plus ddI plus ritonavir plus indinavir plus hydroxyurea. Patients are discontinued from hydroxyurea after Week 24. Group II consists of patients who meet eligibility criteria but who elect not to receive antiretroviral treatment. Patients in Groups I and II follow the same schedule of evaluations. Enrollment visit (Week 0) evaluations are completed prior to dispensing drugs, and all patients have clinical, virologic, and immunologic evaluations performed every 4 weeks through Week 24, then every 8 weeks thereafter. Patients in Group I take study drugs for 104 weeks with an optional 52-week rollover. Laboratory results from the Week 96 evaluation are used to decide whether or not patients continue on study medications. Patients who elect not to participate in the optional rollover or meet criteria for treatment failure at any time during the study are offered the best available treatment at the discretion of their HIV care provider and continue to be followed at 8-week intervals.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Primary Purpose: Treatment
Official Title: A Prospective Randomized Open-Label Clinical Trial to Evaluate the Comparative Efficacy and Safety of a Potent Antiretroviral Treatment Regimen With or Without Hydroxyurea for Subjects With Acute HIV-1 Infection or Recent HIV-1 Seroconversion

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Hydroxyurea

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

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.

Exclusion Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006339

Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: Robert Schooley
Study Chair: Wheaton Williams
Study Chair: Dan Kuritzkes
Study Chair: Elizabeth Connick
Study Chair: Constance Benson

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00006339     History of Changes
Other Study ID Numbers: AI-03-001
11508 ( Registry Identifier: DAIDS ES )
AIEDRP AI-03-001
Substudy AI-03-002
Substudy AI-03-003
Substudy AI-03-004
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: May 21, 2012
Last Verified: May 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Prospective Studies
Drug Therapy, Combination
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Reverse Transcriptase Polymerase Chain Reaction

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antineoplastic Agents
Antisickling Agents