HIVNCT00342160
Viral and Immunologic Factors Contributing to the Lack of HIV Transmission Among Couples in Rakai, Uganda
An observational study of HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Uganda.
Trial summary
This study will look at viral and immunologic factors involved in protecting against sexually transmitted HIV infection in couples in which one partner is infected and the other is not. This study will include 50 couples who reside in Rakai, Uganda, and who have been together for at least 2 years. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV
- How many people
- 88 participants
- Where
- 1 siteUganda
- Study dates
- 15 Feb 2006to 13 Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Group 1 (HIV concordant partners, n = 20 couples):
- Documentation of HIV infection in both partners, a current history of continued sexual activity within the partnership, and demonstration that they have been in a partnership for at least two years.
- CD4+ T cell count greater than 250/microliters blood in both partners and not currently on HAART.
- Plasma viremia greater than 5,000 copies of HIV RNA/ml plasma in both partners.
- Able and willing to provide informed consent.
- Must agree to continued couple counseling regarding HIV results
Show all 17Show fewer
- Group 2 (HIV-discordant partners, n = 20 couples):
- Documentation of HIV infection in one partner and seronegative status in the other partner, a current history of continued sexual activity within the partnership, and demonstration that they have been in a partnership for at least two years.
- CD4+ T cell count greater than 250/microliters blood in both partners and not currently on HAART.
- Plasma viremia greater than 5,000 copies of HIV RNA/ml plasma in each infected partner.
- Able and willing to provide informed consent.
- Must agree to continued couple counseling regarding HIV results
- Group 3 (HIV-uninfected partners, n = 10 couples):
- Documentation of HIV-seronegative status in both partners, a current history of continued sexual activity within the partnership, and demonstration that they have been in a partnership for at least two years.
- CD4+ T cell count greater than 250/microliters blood in both partners.
- Able and willing to provide informed consent.
- Must agree to continued couple counseling regarding HIV results
Who cannot join
- Inability or unwillingness to provide individual informed consent, on the part of either or both members of the couple.
- Refusal of couples counseling on the part of one or both partners.
- Severe illness in one or the other, and /or a hemoglobin value less than 8 g/dL.
- Age less than 18. Children are not included in this study since it specifically focuses on sexual transmission of HIV in long term married couples.
- Having had a blood transfusion within the last 60 days. Though individuals can be scheduled after this time period has passed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virologic and Immunologic Factors Contributing to the Lack of HIV-1 Transmission in HIV-Discordant Couples in Rakai, Uganda
This study will look at viral and immunologic factors involved in protecting against sexually transmitted HIV infection in couples in which one partner is infected and the other is not.
This study will include 50 couples who reside in Rakai, Uganda, and who have been together for at least 2 years. In some couples, both partners will be HIV-infected, in some couples only one partner will have HIV, and in some couples neither partner will have HIV.
Read more
Participants undergo the following procedures at each of four study visits:
- HIV counseling and testing
- Medical history, including questions about personal behaviors such as sexual practices and use of condoms
- Blood sample collection
- Urine sample collection
- Vaginal swab for women
Blood, urine and vaginal fluid samples are tested for HIV and other sexually transmitted diseases, such as syphilis. Blood and vaginal samples are also tested for HIV viral levels and immune response in HIV-infected individuals and for evidence of exposure to HIV in non-infected participants. Some blood is also tested for genetic markers to investigate whether certain proteins are related to resistance to HIV infection.
...
Read the detailed description
Understanding the factors that contribute to the transmission of human immunodeficiency virus (HIV) infection is of great importance for the development of preventive and therapeutic strategies. Evidence suggests that a number of host immunologic and virologic factors play critical roles in protection against sexually transmitted HIV infection in HIV-discordant partners. Among these, the antiviral role of CD8+ T cells in HIV-infected individuals has been extensively studied. At least two types of CD8+ T cell-mediated antiviral activities have been described in HIV infection. The first is a suppressive activity against HIV involving lysis of infected cells in an antigen-specific, HLA-restricted fashion, while the second mechanism inhibits viral replication via either cell- or soluble mediated factors in the absence of cell killing. It has been demonstrated that cytotoxic CD8+ T lymphocytes (CTL) are present in both cervical and peripheral blood mononuclear cells (PBMC) from a subpopulation of highly-HIV-exposed but persistently seronegative individuals. However, studies addressing the effect of non-cytotoxic soluble factor-mediated antiviral activity by CD8+ T cells in preventing seroconversion in HIV-discordant couples have been lacking. This study proposes to examine the role of CD8+ T cell-derived CC-chemokine activities and the copy numbers of one of the chemokine genes, CCL3L1, along with other host anti-HIV and virologic factors in resistance to HIV infection in persistently seronegative HIV-discordant partners of HIV infected individuals.
- Conditions
- HIV
- Keywords
- AIDS, HIV Infectiousness, Immunity, CTL, Epidemiology
- Medical subject headings
- Acquired Immunodeficiency Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start15 Feb 2006
- Study completion13 Nov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Thomas C Quinn, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00342160
- Sponsor's protocol ID
- 999906100
- Other IDs
- 06-I-N100
- Status last verified
- 13 Nov 2012
- First submitted
- 19 Jun 2006
- Last updated
- 16 Dec 2019
- Results posted
- No
Publications
Blocker ME, Cohen MS. Biologic approaches to the prevention of sexual transmission of human immunodeficiency virus. Infect Dis Clin North Am. 2000 Dec;14(4):983-99. doi: 10.1016/s0891-5520(05)70143-4.
PubMed 11144648Quinn TC, Wawer MJ, Sewankambo N, Serwadda D, Li C, Wabwire-Mangen F, Meehan MO, Lutalo T, Gray RH. Viral load and heterosexual transmission of human immunodeficiency virus type 1. Rakai Project Study Group. N Engl J Med. 2000 Mar 30;342(13):921-9. doi: 10.1056/NEJM200003303421303.
PubMed 10738050Vernazza PL, Troiani L, Flepp MJ, Cone RW, Schock J, Roth F, Boggian K, Cohen MS, Fiscus SA, Eron JJ. Potent antiretroviral treatment of HIV-infection results in suppression of the seminal shedding of HIV. The Swiss HIV Cohort Study. AIDS. 2000 Jan 28;14(2):117-21. doi: 10.1097/00002030-200001280-00006.
PubMed 10708281
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virologic and Immunologic Factors Contributing to the Lack of HIV-1 Transmission in HIV-Discordant Couples in Rakai, Uganda
- ClinicalTrials.gov ID
- NCT00342160
- Acronym / sponsor ID
- 999906100
- Conditions
- HIV
- Keywords
- AIDS, HIV Infectiousness, Immunity, CTL, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 15 Feb 2006
- Study completion
- 13 Nov 2012
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at viral and immunologic factors involved in protecting against sexually transmitted HIV infection in couples in which one partner is infected and the other is not.
This study will include 50 couples who reside in Rakai, Uganda, and who have been together for at least 2 years. In some couples, both partners will be HIV-infected, in some couples only one partner will have HIV, and in some couples neither partner will have HIV.
Participants undergo the following procedures at each of four study visits:
- HIV counseling and testing
- Medical history, including questions about personal behaviors such as sexual practices and use of condoms
- Blood sample collection
- Urine sample collection
- Vaginal swab for women
Blood, urine and vaginal fluid samples are tested for HIV and other sexually transmitted diseases, such as syphilis. Blood and vaginal samples are also tested for HIV viral levels and immune response in HIV-infected individuals and for evidence of exposure to HIV in non-infected participants. Some blood is also tested for genetic markers to investigate whether certain proteins are related to resistance to HIV infection.
...
Detailed description
Understanding the factors that contribute to the transmission of human immunodeficiency virus (HIV) infection is of great importance for the development of preventive and therapeutic strategies. Evidence suggests that a number of host immunologic and virologic factors play critical roles in protection against sexually transmitted HIV infection in HIV-discordant partners. Among these, the antiviral role of CD8+ T cells in HIV-infected individuals has been extensively studied. At least two types of CD8+ T cell-mediated antiviral activities have been described in HIV infection. The first is a suppressive activity against HIV involving lysis of infected cells in an antigen-specific, HLA-restricted fashion, while the second mechanism inhibits viral replication via either cell- or soluble mediated factors in the absence of cell killing. It has been demonstrated that cytotoxic CD8+ T lymphocytes (CTL) are present in both cervical and peripheral blood mononuclear cells (PBMC) from a subpopulation of highly-HIV-exposed but persistently seronegative individuals. However, studies addressing the effect of non-cytotoxic soluble factor-mediated antiviral activity by CD8+ T cells in preventing seroconversion in HIV-discordant couples have been lacking. This study proposes to examine the role of CD8+ T cell-derived CC-chemokine activities and the copy numbers of one of the chemokine genes, CCL3L1, along with other host anti-HIV and virologic factors in resistance to HIV infection in persistently seronegative HIV-discordant partners of HIV infected individuals.
Study design
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Documentation of HIV infection in both partners, a current history of continued sexual activity within the partnership, and demonstration that they have been in a partnership for at least two years.
- CD4+ T cell count greater than 250/microliters blood in both partners and not currently on HAART.
- Plasma viremia greater than 5,000 copies of HIV RNA/ml plasma in both partners.
- Able and willing to provide informed consent.
- Must agree to continued couple counseling regarding HIV results
Key exclusion criteria (5 listed)
- Inability or unwillingness to provide individual informed consent, on the part of either or both members of the couple.
- Refusal of couples counseling on the part of one or both partners.
- Severe illness in one or the other, and /or a hemoglobin value less than 8 g/dL.
- Age less than 18. Children are not included in this study since it specifically focuses on sexual transmission of HIV in long term married couples.
- Having had a blood transfusion within the last 60 days. Though individuals can be scheduled after this time period has passed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Background: PubMed 11144648Blocker ME, Cohen MS. Biologic approaches to the prevention of sexual transmission of human immunodeficiency virus. Infect Dis Clin North Am. 2000 Dec;14(4):983-99. doi: 10.1016/s0891-5520(05)70143-4.
- Background: PubMed 10738050Quinn TC, Wawer MJ, Sewankambo N, Serwadda D, Li C, Wabwire-Mangen F, Meehan MO, Lutalo T, Gray RH. Viral load and heterosexual transmission of human immunodeficiency virus type 1. Rakai Project Study Group. N Engl J Med. 2000 Mar 30;342(13):921-9. doi: 10.1056/NEJM200003303421303.
- Background: PubMed 10708281Vernazza PL, Troiani L, Flepp MJ, Cone RW, Schock J, Roth F, Boggian K, Cohen MS, Fiscus SA, Eron JJ. Potent antiretroviral treatment of HIV-infection results in suppression of the seminal shedding of HIV. The Swiss HIV Cohort Study. AIDS. 2000 Jan 28;14(2):117-21. doi: 10.1097/00002030-200001280-00006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas C Quinn, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00342160, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.