Effectiveness of Antiretroviral Therapy During Acute HIV Infection

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eric Rosenberg, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00705926
First received: June 25, 2008
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Highly Active Antiretroviral Therapy (HAART)
Other: No treatment
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Clinical Trial to Evaluate the Initiation of Treatment Versus no Treatment During Acute HIV-1 Infection

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Difference in the level of HIV RNA at viral load set point if therapy is initiated during acute HIV infection followed by terminal treatment interruption after 12 or 32 weeks of treatment compared to that under no treatment [ Time Frame: Week 72 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in the level of CD4 cells if therapy is initiated during acute HIV infection followed by terminal treatment interruption after 12 or 32 weeks of treatment compared to that under no treatment [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
  • Difference in the level of HIV RNA and CD4 cell numbers between therapy initiated during acute HIV infection followed by terminal treatment interruption after at least 12 weeks of treatment and no therapy at 16 weeks after discontinuation of treatment [ Time Frame: Weeks 12 and 16 ] [ Designated as safety issue: No ]
  • Difference in the level of HIV at viral load set point and CD4 cell number at 72 weeks after study entry if therapy is initiated during acute HIV infection followed by terminal treatment interruption at 12 weeks versus at 32 weeks [ Time Frame: Week 72 ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: October 2008
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1
Antiretroviral therapy followed by discontinuation at Week 12.
Drug: 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.
Experimental: A2
Antiretroviral therapy followed by discontinuation at Week 32.
Drug: 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.
Placebo Comparator: B
No treatment.
Other: No treatment
Participants in this group will not receive treatment at this stage of their infection.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705926

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Study Chair: Eric S. Rosenberg, MD Massachusetts General Hospital, Division of Infectious Diseases
Principal Investigator: H.T. Banks, PhD North Carolina State University, College of Physical and Mathematical Sciences
Principal Investigator: Marie Davidian, PhD North Carolina State University, Department of Statistics
  More Information

Publications:
Responsible Party: Eric Rosenberg, MD, Investigator of Record, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00705926     History of Changes
Other Study ID Numbers: R01 AI071915, RO1AIO71915
Study First Received: June 25, 2008
Last Updated: April 2, 2013
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Acute Infection
HIV
HAART
Treatment Naive

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 31, 2014