HIVPhase 2MSRCNCT00807625
Impact of Different Contraceptives on the Immune System of HIV Infected Women in Zambia
A Phase 2 study testing Depo Provera and Copper T Intrauterine contraception device in people with HIV and Contraception, run by University of Alabama at Birmingham at 1 site in Zambia.
Trial summary
In this study, 66 HIV-infected women who desire contraception will be randomly assigned to use either an IUD or Depo Provera, and will be followed for six months. The study is intended to help investigators understand potential mechanisms by which hormonal contraception may hasten HIV disease progression. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- HIV, Contraception, HIV Infections
- What is being tested?
- Depo Provera and Copper T Intrauterine contraception device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteZambia
- Study dates
- Nov 2008to Jul 2010
- Phase
- Phase 2
- 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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed HIV status by local rapid test algorithm
- Willingness to be randomized to a contraceptive method and continue that method for at least 6 months.
- Intention to stay in the study area for at least 6 months
Who cannot join
- Currently pregnant or pregnant within the prior 6 months
- Currently breastfeeding
- Documented liver disease
- History of coagulation disorder
- Active tuberculosis
- Anemia, defined as Hgb <8gm/dL
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- Age < 16 years (the age of consent in Zambia);
- Eligible for antiretroviral therapy based on Zambian National Guidelines (CD4+ < 200, or WHO stage IV, or CD4+< 350 and WHO stage III)
- Currently using an IUD or hormonal method of contraception, or have used a hormonal contraceptive in the past 6 months
Trial locations and contacts
1 site in 1 country.
Zambia1 site
The Centre for Infectious Disease Research in Zambia
Lusaka, Lusaka Province
About this study
Official title: Mucosal and Systemic Responses to Contraceptives in HIV-Infected Women in Zambia
In this study, 66 HIV-infected women who desire contraception will be randomly assigned to use either an IUD or Depo Provera, and will be followed for six months. The study is intended to help investigators understand potential mechanisms by which hormonal contraception may hasten HIV disease progression.
Read the detailed description
In this randomized controlled trial, 66 HIV-infected women who desire contraception will be assigned to one of two treatment groups: IUD or Depo Provera. The study builds on findings from a previous study which examined the safety and acceptability of hormonal contraception and IUD among HIV-infected women. Secondary analyses from the previous study indicated that women who were assigned to the hormonal arm appeared to have faster disease progression based on death and decline in CD4+ count as compared to women assigned to the IUD arm. With the current study, investigators seek to understand potential mechanisms for the effect of hormonal contraception on hastening HIV disease progression. Enrolled women will be asked to use the assigned contraception method for a period of six months, and various indicators of disease progression will be collected at four follow-up visits after randomization.
- Conditions
- HIV, Contraception, HIV Infections
- Being tested
- Depo Provera, Copper T Intrauterine contraception device
- Keywords
- HIV/AIDS, Contraception, Birth control, CD4+, Viral Load, T-cell activation, B-cell activation, Hormonal, Intrauterine device, Depo Provera, Women, IUCD, treatment naive
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depo ProveraDrug
Depo Provera administered by injection at randomization visit and the 12-week study visit.
Copper T Intrauterine contraception deviceDevice
Also called ParaGuard TCu 380A
IUCD inserted upon randomization to this study arm
| Study group | Role | What they receive |
|---|---|---|
| IUCD | Active comparator | Assigned to use a copper intrauterine device Receives: Device: Copper T Intrauterine contraception device |
| DMPA | Active comparator | Assigned to use Depo Provera Receives: Drug: Depo Provera |
What is being measured
The primary outcome is the main question the study is designed to answer.
T-cell activation
Measured: 4, 8, 12, and 24 weeks post-randomization
Secondary outcomes (2)
CD4+ cell decline
Measured: 4, 8, 12, and 24 weeks post-randomization
Cervical viral load
Measured: 4, 8, 12, and 24 weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth M Stringer, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807625
- Sponsor's protocol ID
- F071227004
- Acronym
- MSRC
- Status last verified
- Jul 2012
- First submitted
- 11 Dec 2008
- Last updated
- 13 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mucosal and Systemic Responses to Contraceptives in HIV-Infected Women in Zambia
- ClinicalTrials.gov ID
- NCT00807625
- Acronym / sponsor ID
- MSRC / F071227004
- Conditions
- HIV, Contraception, HIV Infections
- Keywords
- HIV/AIDS, Contraception, Birth control, CD4+, Viral Load, T-cell activation, B-cell activation, Hormonal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 12 Dec 2008 (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.
In this study, 66 HIV-infected women who desire contraception will be randomly assigned to use either an IUD or Depo Provera, and will be followed for six months. The study is intended to help investigators understand potential mechanisms by which hormonal contraception may hasten HIV disease progression.
Detailed description
In this randomized controlled trial, 66 HIV-infected women who desire contraception will be assigned to one of two treatment groups: IUD or Depo Provera. The study builds on findings from a previous study which examined the safety and acceptability of hormonal contraception and IUD among HIV-infected women. Secondary analyses from the previous study indicated that women who were assigned to the hormonal arm appeared to have faster disease progression based on death and decline in CD4+ count as compared to women assigned to the IUD arm. With the current study, investigators seek to understand potential mechanisms for the effect of hormonal contraception on hastening HIV disease progression. Enrolled women will be asked to use the assigned contraception method for a period of six months, and various indicators of disease progression will be collected at four follow-up visits after randomization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IUCD | Active comparator | Device: Copper T Intrauterine contraception deviceAssigned to use a copper intrauterine device |
| DMPA | Active comparator | Drug: Depo ProveraAssigned to use Depo Provera |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed HIV status by local rapid test algorithm
- Willingness to be randomized to a contraceptive method and continue that method for at least 6 months.
- Intention to stay in the study area for at least 6 months
Key exclusion criteria (9 listed)
- Currently pregnant or pregnant within the prior 6 months
- Currently breastfeeding
- Documented liver disease
- History of coagulation disorder
- Active tuberculosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Depo ProveraDepo Provera administered by injection at randomization visit and the 12-week study visit. | Drug | DMPA |
| Copper T Intrauterine contraception deviceAlso: ParaGuard TCu 380AIUCD inserted upon randomization to this study arm | Device | IUCD |
Primary outcome
T-cell activation
Time frame: 4, 8, 12, and 24 weeks post-randomization
2 secondary outcomes
CD4+ cell decline
Time frame: 4, 8, 12, and 24 weeks post-randomization
Cervical viral load
Time frame: 4, 8, 12, and 24 weeks post-randomization
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 13 Jul 2012.
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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.
Elizabeth M Stringer, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Depo Provera and Copper T Intrauterine contraception device in people with HIV and Contraception, run by University of Alabama at Birmingham at 1 site in Zambia.
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 3 inclusion and 9 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 13 Jul 2012. 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 Zambia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
T-cell activation (time frame: 4, 8, 12, and 24 weeks post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2012.