NCT00067106

Brief Summary

HIV is found in both the blood and the genital tract. This study will compare the levels and types of HIV found in the blood with the levels and types of HIV found in the female genital tract. Study hypotheses: 1) In the presence of antiretroviral therapy, viral replication within the female genital tract may lead to the development of drug resistance that is different from that of virus in the blood plasma. 2) Antiretroviral drug levels in the female genital tract may often be lower than in the blood plasma and differences in drug exposure may be associated with differences in virus replication and selection of resistant HIV variants during drug failure. 3) HIV can be recovered in vitro from cells in the female genital tract during successful therapy, and it may be genetically different from the HIV variants recovered from the blood cell latent reservoir on the same visit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2003

Longer than P75 for all trials

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

Study Start

First participant enrolled

July 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 11, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2003

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

May 19, 2015

Status Verified

September 1, 2014

Enrollment Period

3.7 years

First QC Date

August 11, 2003

Last Update Submit

May 15, 2015

Conditions

HIV Infections

Keywords

HIVWomenGenital tractTreatment experiencedDrug resistance

Outcome Measures

Primary Outcomes (1)

  • Antiviral Therapy and HIV in the Female Genital Tract

    The primary analysis will be to compare resistance mutation patterns in blood plasma versus CVL population sequences.

    2004-2009

Secondary Outcomes (1)

  • Antiviral Therapy and HIV in the Female Genital Tract

    2004-2009

Study Arms (2)

1: Women failing therapy

Participants will have study visits at study entry, 2 weeks after changing medications, then every 4 weeks until the amount of HIV in the blood and genital tract are undetectable. Drug levels in the blood and genital tract will also be measured at the first visit and after changing medications. Once the level of HIV is undetectable, women will be seen every 3 months for 36 months. Participants in Group 1 will be followed no more than 42 months.

2: Women suppressed on therapy

Participants will have study visits for blood and genital tract collections at study entry and then every 4 weeks for 12 months

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV-infected women who are failing their current antiretroviral regimen and those who are fully suppressed on antiretroviral therapy

You may qualify if:

  • HIV-infected
  • Viral load below detectable limits for at least 6 months prior to study entry
  • Have not failed an antiretroviral regimen or have failed only one previous antiretroviral regimen
  • HIV-infected
  • Viral load more than 1,000 copies/ml on at least two occasions, with one viral load more than 10,000 copies/ml
  • Expect to change to a new antiretroviral regimen

You may not qualify if:

  • Women not on antiretroviral therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (3)

  • Venkatesh KK, DeLong AK, Kantor R, Chapman S, Ingersoll J, Kurpewski J, De Pasquale MP, D'Aquila R, Caliendo AM, Cu-Uvin S. Persistent genital tract HIV-1 RNA shedding after change in treatment regimens in antiretroviral-experienced women with detectable plasma viral load. J Womens Health (Larchmt). 2013 Apr;22(4):330-8. doi: 10.1089/jwh.2012.3849. Epub 2013 Mar 26.

    PMID: 23531097RESULT

  • Cu-Uvin S, Caliendo AM. Genital tract HIV-1 RNA shedding among women with below detectable plasma viral load. AIDS. 2011 Mar 27;25(6):880-1. doi: 10.1097/QAD.0b013e328344ccf8. No abstract available.

    PMID: 21412068RESULT

  • Cu-Uvin S, DeLong AK, Venkatesh KK, Hogan JW, Ingersoll J, Kurpewski J, De Pasquale MP, D'Aquila R, Caliendo AM. Genital tract HIV-1 RNA shedding among women with below detectable plasma viral load. AIDS. 2010 Oct 23;24(16):2489-97. doi: 10.1097/QAD.0b013e32833e5043.

    PMID: 20736815RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood and genital tract collection

MeSH Terms

Conditions

HIV Infections

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

  • Susan Cu-Uvin, MD

    The Miriam Hospital, Brown Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2003

First Posted

August 13, 2003

Study Start

July 1, 2003

Primary Completion

March 1, 2007

Study Completion

March 1, 2009

Last Updated

May 19, 2015

Record last verified: 2014-09

Locations

US(1)