Effectiveness of Antiretroviral Therapy During Acute HIV Infection

NCT ID: NCT00705926

Last Updated: 2017-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2017-07-16

Brief Summary

This study will determine whether HIV treatment that is initiated during the acute phase of HIV infection, followed by discontinuation of treatment, is effective in reducing the amount of HIV and an increasing the amount of CD4 cells in the blood of people with HIV, compared to the amounts of HIV and CD4 cells in people who do not receive treatment at this stage.

Detailed Description

Antiretroviral (ARV) therapy for the treatment of HIV infection has been remarkably successful in reducing morbidity and mortality in HIV infected people. This treatment still has its shortcomings, however. Individuals receiving ARV treatment are at risk of toxicity, developing drug resistance, and unknown long-term side effects. Therefore, development of alternative treatment strategies is important. A short course of ARV treatment that is initiated during the acute period of HIV infection, followed by treatment cessation may have a substantial impact on controlling infection and delaying the need for lifelong potent ARV therapy. The purpose of this study is to investigate whether treatment initiated during acute HIV infection and followed by a terminal treatment interruption is effective in lowering the viral load set point and raising CD4 cell counts in people with HIV, as compared to those measures in people with HIV who have received no treatment.

Participants in this study will be randomly assigned to one of three groups. Participants in Group A1 will receive ARV therapy for 12 weeks. Participants in Group A2 will receive ARV therapy for 32 weeks. Participants in Group B will not receive any treatment. This study will not provide medications to any of the groups. All groups will be followed for a total of 72 weeks following study entry. Participants will attend between 30 and 36 study visits over the course of the 72 weeks, depending on their study group. Study visits will occur every week for the first 12 weeks and then every 1 to 6 weeks for the remainder of the study. Tests occurring at study visits may include blood tests, investigational immune system tests, and pregnancy tests. Participants will also undergo a complete physical exam and will be asked to provide information about their medical and medication histories.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A1

Antiretroviral therapy followed by discontinuation at Week 12.

Group Type: EXPERIMENTAL

Highly Active Antiretroviral Therapy (HAART)

Intervention Type: DRUG

Participants in Groups A1 and A2 will receive HAART for either 12 or 32 weeks. Their medications will not be provided by the study.

A2

Antiretroviral therapy followed by discontinuation at Week 32.

Group Type: EXPERIMENTAL

Highly Active Antiretroviral Therapy (HAART)

Intervention Type: DRUG

Participants in Groups A1 and A2 will receive HAART for either 12 or 32 weeks. Their medications will not be provided by the study.

B

No treatment.

Group Type: PLACEBO_COMPARATOR

No treatment

Intervention Type: OTHER

Participants in this group will not receive treatment at this stage of their infection.

Interventions

Highly Active Antiretroviral Therapy (HAART)

Participants in Groups A1 and A2 will receive HAART for either 12 or 32 weeks. Their medications will not be provided by the study.

Intervention Type: DRUG

No treatment

Participants in this group will not receive treatment at this stage of their infection.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Acute HIV infection as determined by a positive HIV viral load (at least 5,000 copies of RNA per ml of plasma) and a negative or indeterminate Western Blot test
• Certain laboratory values. More information about this criterion can be found in the protocol.
• Agrees to use an approved form of contraception

Exclusion Criteria

• Presence of opportunistic infections or AIDS-defining illnesses, unless they are directly attributable to the acute seroconversion illness
• Receipt of investigational research agents within 30 days prior to study entry
• Receipt of prior experimental HIV vaccines. Individuals who received a saline placebo in a prior HIV vaccine trial are not excluded, provided that they did not receive a sham vector or an adjuvant.
• Receipt of immunosuppressive medications or immunomodulators (e.g., cytokine therapy) within the past 6 months. Participants taking corticosteroid nasal spray for allergic rhinitis; topical corticosteroids for acute, uncomplicated dermatitis; or over the counter medications for acute, uncomplicated dermatitis for a period not longer than 14 days will not be excluded.
• Current use of prohibited concomitant medications
• Current anti-tuberculosis prophylaxis or therapy
• Serious illness other than acute HIV infection requiring systemic treatment or hospitalization until either therapy is completed or patient is clinically stable on therapy
• Hepatitis B surface antigen positivity within 21 days prior to study entry
• Pregnant or breastfeeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Eric Rosenberg, MD

Investigator of Record

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric S. Rosenberg, MD

Role: STUDY_CHAIR

Massachusetts General Hospital, Division of Infectious Diseases

H.T. Banks, PhD

Role: PRINCIPAL_INVESTIGATOR

North Carolina State University, College of Physical and Mathematical Sciences

Marie Davidian, PhD

Role: PRINCIPAL_INVESTIGATOR

North Carolina State University, Department of Statistics

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Kassutto S, Maghsoudi K, Johnston MN, Robbins GK, Burgett NC, Sax PE, Cohen D, Pae E, Davis B, Zachary K, Basgoz N, D'agata EM, DeGruttola V, Walker BD, Rosenberg ES. Longitudinal analysis of clinical markers following antiretroviral therapy initiated during acute or early HIV type 1 infection. Clin Infect Dis. 2006 Apr 1;42(7):1024-31. doi: 10.1086/500410. Epub 2006 Feb 27.

Reference Type: BACKGROUND

PMID: 16511771 (View on PubMed)

Kassutto S, Rosenberg ES. Editorial comment: treatment of acute HIV infection--uncertainties about best practice. AIDS Read. 2005 May;15(5):250-1. No abstract available.

Reference Type: BACKGROUND

PMID: 15900635 (View on PubMed)

Kassutto S, Rosenberg ES. Primary HIV type 1 infection. Clin Infect Dis. 2004 May 15;38(10):1447-53. doi: 10.1086/420745. Epub 2004 Apr 30.

Reference Type: BACKGROUND

PMID: 15156484 (View on PubMed)

Lacabaratz-Porret C, Urrutia A, Doisne JM, Goujard C, Deveau C, Dalod M, Meyer L, Rouzioux C, Delfraissy JF, Venet A, Sinet M. Impact of antiretroviral therapy and changes in virus load on human immunodeficiency virus (HIV)-specific T cell responses in primary HIV infection. J Infect Dis. 2003 Mar 1;187(5):748-57. doi: 10.1086/368333. Epub 2003 Feb 18.

Reference Type: BACKGROUND

PMID: 12599048 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10608758 (View on PubMed)

Other Identifiers

RO1AIO71915

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

R01AI071915

Identifier Type: NIH

Identifier Source: org_study_id

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