NCT00006415

Brief Summary

The purpose of this study is to find out if anti-HIV drugs, taken by patients who are newly infected with HIV, can make the level of HIV in the body too low to detect. Studying patients who recently have been infected with HIV may help researchers understand how HIV infection works and how anti-HIV drugs may help these patients. Approved anti-HIV drugs can reduce the amount of HIV, but more research needs to be done in newly infected patients. This study will look at recently HIV-infected patients to study the progression of HIV disease and to see whether anti-HIV drugs can reduce the level of HIV.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2000

Completed
11 months until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

March 9, 2015

Status Verified

March 1, 2015

First QC Date

October 19, 2000

Last Update Submit

March 5, 2015

Conditions

HIV Infections

Keywords

Virus ReplicationHIV-1Polymerase Chain ReactionDNA, ViralRNA, ViralSensitivity and SpecificityAnti-HIV AgentsViral LoadProvirusesAcute Infection

Eligibility Criteria

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

You may qualify if:

  • Patients may be eligible for this study if they:
  • Have had certain tests indicating that they recently have been infected with HIV.
  • Agree to use effective methods of birth control during the study and for 3 months after.
  • Are at least 18 years old.

You may not qualify if:

  • Patients will not be eligible for this study if they:
  • Have taken anti-HIV drugs.
  • Take erythropoietin, G-CSF or GM-CSF within 30 days of study entry.
  • Take interferons, interleukins, cytotoxic chemotherapy, or HIV vaccines within 30 days of study entry.
  • Take medications that should not be taken with their prescribed anti-HIV drugs.
  • Have had radiation treatment within 30 days of study entry.
  • Are pregnant or breast-feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Horsham, Pennsylvania, 19044, United States

Location

MeSH Terms

Conditions

HIV InfectionsHypersensitivity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Margaret Fischl

    STUDY CHAIR

  • Allan Rodriguez

    STUDY CHAIR

  • Ernesto Scerpella

    STUDY CHAIR
0

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

October 19, 2000

First Posted

August 31, 2001

Last Updated

March 9, 2015

Record last verified: 2015-03

Locations

US(1)