NCT00705926

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Timeline
Completed

Started Oct 2008

Longer than P75 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2013

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2017

Completed
Last Updated

August 31, 2017

Status Verified

August 1, 2017

Enrollment Period

4.4 years

First QC Date

June 25, 2008

Last Update Submit

August 30, 2017

Conditions

HIV Infections

Keywords

Acute InfectionHIVHAARTTreatment Naive

Outcome Measures

Primary Outcomes (1)

  • 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

    Week 72

Secondary Outcomes (3)

  • 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

    Week 72

  • 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

    Weeks 12 and 16

  • 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

    Week 72

Study Arms (3)

A1

EXPERIMENTAL

Antiretroviral therapy followed by discontinuation at Week 12.

Drug: Highly Active Antiretroviral Therapy (HAART)

A2

EXPERIMENTAL

Antiretroviral therapy followed by discontinuation at Week 32.

Drug: Highly Active Antiretroviral Therapy (HAART)

B

PLACEBO COMPARATOR

No treatment.

Other: No treatment

Interventions

Highly Active Antiretroviral Therapy (HAART)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.

A1A2
No treatmentOTHER

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

B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (5)

  • 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.

    PMID: 16511771BACKGROUND

  • 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.

    PMID: 15900635BACKGROUND

  • 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.

    PMID: 15156484BACKGROUND

  • 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.

    PMID: 12599048BACKGROUND

  • 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: 10608758BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Antiretroviral Therapy, Highly Active

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy, CombinationDrug TherapyTherapeutics

Study Officials

  • Eric S. Rosenberg, MD

    Massachusetts General Hospital, Division of Infectious Diseases

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator of Record

Study Record Dates

First Submitted

June 25, 2008

First Posted

June 27, 2008

Study Start

October 1, 2008

Primary Completion

February 7, 2013

Study Completion

July 16, 2017

Last Updated

August 31, 2017

Record last verified: 2017-08

Locations

US(1)