Anti-HIV Medications and Structured Treatment Interruptions for People Recently Infected With HIV

NCT00084032 | Withdrawn

• 1 other identifier: AIEDRP AIN502
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

People recently infected with HIV who are treated with anti-HIV medications may develop strong immune system responses to HIV and may be able to control the virus without continuing to take these medications. The purpose of this study is to see if giving anti-HIV medications to people soon after they have been infected with HIV can help them control HIV. The study will also see if the immune system can control the amount of HIV virus in the blood (viral load) even after a person has stopped taking the medications. The study will evaluate three different schedules of stopping and starting anti-HIV medications to see which schedule is best able to boost a patient's immune system to control HIV viral load. Hypothesis: Combination therapy started in primary HIV infection, in conjunction with structured treatment interruptions, will result in greater control of viremia off treatment than induction therapy alone.

Conditions

HIV Infections

Keywords

Acute Infection; Treatment Interruption; Treatment Naive; Primary HIV Infection; PHI

Outcome Measures

Primary Outcomes (1)

• Difference in mean HIV viral load between arms

  At Week 80

Study Arms (2)

1

EXPERIMENTAL

In Step 1, participants will receive ARV therapy for 24 weeks. Upon entering Step 2, participants will continue taking ARV therapy for 16 weeks and then stop ARVs for 64 weeks.

Behavioral: Structured treatment interruption; Drug: Antiretroviral regimen

2

EXPERIMENTAL

In Step 1, participants will receive ARV therapy for 24 weeks. Upon entering Step 2, participants will stop ARVs for 4 weeks, take ARVs for 8 weeks, stop ARVs for 4 weeks, take ARVs for 8 weeks, and then stop ARVs for 56 weeks.

Behavioral: Structured treatment interruption; Drug: Antiretroviral regimen

Interventions

Structured treatment interruption BEHAVIORAL

Treatment interruption schedule is dependent on the Arm in which participants are enrolled in Step 2

1; 2

Antiretroviral regimen DRUG

Participants will take any combination of FDA-approved ARV medications prescribed by their physician

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute or early HIV infection as defined by the study
• Agrees to use acceptable methods of contraception
• Agrees to begin antiretroviral treatment regimen within 21 days of diagnosis and no more than 3 days after study entry

You may not qualify if:

• Unwilling to follow random assignment in Step 2
• Abnormal laboratory result within 21 days prior to study entry, unless abnormality is considered part of acute HIV infection
• Have taken antiretroviral drugs other than for postexposure prophylaxis (PEP). Patients who have undergone up to 30 days of previous PEP treatment are not excluded.
• Pregnancy or breastfeeding
• Previous participation in an HIV vaccine trial
• Previous use of experimental therapeutic immunizations or cytokine infusions
• Viral load of less than 400 copies/ml
• Enrolled in the AIEDRP CORE01 study, with stored blood samples obtained within 21 days prior to starting treatment on CORE01
• Currently receiving antiretroviral treatment regimen, with no interruptions for more than 7 consecutive days since the beginning of treatment
• Antiretroviral treatment was started within 21 days after HIV diagnosis
• Agrees to use acceptable methods of contraception
• Unwilling to follow random assignment to study arms and follow scheduled treatment interruptions
• More than 52 weeks of ARV treatment since diagnosis of acute/early HIV infection prior to entering Step 2
• CD4 count less than 350 cells/mm3 within 28 days of entry into Step 2
• AIDS-defining illness

Sponsors & Collaborators

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

Related Publications (5)

• Girard PM, Schneider V, Dehee A, Mariot P, Jacomet C, Delphin N, Damond F, Carcelain G, Autran B, Saimot AG, Nicolas JC, Rozenbaum W. Treatment interruption after one year of triple nucleoside analogue therapy for primary HIV infection. AIDS. 2001 Jan 26;15(2):275-7. doi: 10.1097/00002030-200101260-00020. No abstract available.

  PMID: 11216939 BACKGROUND

• Kaufmann GR, Zaunders JJ, Cunningham P, Kelleher AD, Grey P, Smith D, Carr A, Cooper DA. Rapid restoration of CD4 T cell subsets in subjects receiving antiretroviral therapy during primary HIV-1 infection. AIDS. 2000 Dec 1;14(17):2643-51. doi: 10.1097/00002030-200012010-00003.

  PMID: 11125882 BACKGROUND

• Malhotra U, Berrey MM, Huang Y, Markee J, Brown DJ, Ap S, Musey L, Schacker T, Corey L, McElrath MJ. Effect of combination antiretroviral therapy on T-cell immunity in acute human immunodeficiency virus type 1 infection. J Infect Dis. 2000 Jan;181(1):121-31. doi: 10.1086/315202.

  PMID: 10608758 BACKGROUND

• Markowitz M, Jin X, Hurley A, Simon V, Ramratnam B, Louie M, Deschenes GR, Ramanathan M Jr, Barsoum S, Vanderhoeven J, He T, Chung C, Murray J, Perelson AS, Zhang L, Ho DD. Discontinuation of antiretroviral therapy commenced early during the course of human immunodeficiency virus type 1 infection, with or without adjunctive vaccination. J Infect Dis. 2002 Sep 1;186(5):634-43. doi: 10.1086/342559. Epub 2002 Aug 9.

  PMID: 12195350 BACKGROUND

• Walensky RP, Goldie SJ, Sax PE, Weinstein MC, Paltiel AD, Kimmel AD, Seage GR 3rd, Losina E, Zhang H, Islam R, Freedberg KA. Treatment for primary HIV infection: projecting outcomes of immediate, interrupted, or delayed therapy. J Acquir Immune Defic Syndr. 2002 Sep 1;31(1):27-37. doi: 10.1097/00126334-200209010-00004.

  PMID: 12352147 BACKGROUND

Related Links

• Click here for more information on AIEDRP CORE01

MeSH Terms

Conditions

HIV Infections

Interventions

Treatment Interruption

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)

Treatment Adherence and Compliance; Attitude to Health; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Eric Rosenberg, MD

  Massachusetts General Hospital

  STUDY CHAIR

• Don Smith, MB, ChB, MD

  University of New South Wales, Australia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2004
• First Posted: June 7, 2004
• Last Updated: October 29, 2012

Record last verified: 2012-10