HIV/AIDSPhase 4NCT00829114
Interactions Between Antiretrovirals (ARVs) and Combined Oral Contraceptives (COCs)
A Phase 4 study testing ETHINYL ESTRADIOL AND LEVOGESTREL in people with HIV/AIDS and HIV Infections, run by FHI 360 at 2 sites in 2 countries.
Trial summary
Non-randomized, comparative study (1:1 allocation) to study interactions between nevirapine-containing antiretroviral therapies and combined oral contraceptive pills. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- HIV/AIDS, HIV Infections
- What is being tested?
- ETHINYL ESTRADIOL AND LEVOGESTREL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2009to Apr 2011
- Phase
- Phase 4
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Willing to provide informed consent
- Willing to take COCs and follow all study requirements
- Has regular menstrual cycles every 21-35 days (when not taking hormonal contraception)
- Last menstrual period (LMP) <35 days before study entry
- Has body mass index of 18-30
- Negative urine pregnancy test as enrollment
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- Documented HIV-1 infection
- On nevirapine-containing ART for at least three months (ART group only)
- CD4 cell count of greater than or equal to 350 (for non-ARV group only)
- Currently sexually active and plans to stay sexually active for the next 6 months
Who cannot join
- Medical contraindications to COC use
- Recent pregnancy (within 3 months)
- Has breastfed in last 3 months
- Last pregnancy was ectpoic
- Has been sterilized
- Has had any of the following conditions since last pregnancy, or since menarche if never pregnant:
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- Pelvic Inflammatory disease Diagnosis of infertility
- Has had DMPA within 6 months or NET injectable within 3 months of study entry (or has had no menses since last injection regardless of its timing)
- has taken other hormonal therapies besides COCs (e.g., combined injectables, progestin implants or intrauterine systems, progestin-only contraceptive pills, medroxyprogesterone acetate, hormone replacement therapy) within 30 days of study entry
- Has an acute infection or other opportunistic diseases requiring therapy within 14 days before enrollment
- Has active drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements
- Has taken any prohibited medication within 30 days before study entry
- Has chronic diarrhea, malabsorption or inability to maintain an adequate oral intake
- Has any condition (social or medical) which in the opinion of the investigator would make study participation unsafe or complicate data interpretation
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
South Africa1 site
, RHRU National Office, University of Witwatersand
Esselent Saint Hillbrow, Johannesburg, 2001
Uganda1 site
Makerere University Medical School, Mulago Hospital, Department of Obstetrics and Gynecology
Kampala, Kampala
About this study
Official title: Interactions Between Antiretrovirals and Combined Oral Contraceptive Pills
Non-randomized, comparative study (1:1 allocation) to study interactions between nevirapine-containing antiretroviral therapies and combined oral contraceptive pills.
- Conditions
- HIV/AIDS, HIV Infections
- Being tested
- ETHINYL ESTRADIOL AND LEVOGESTREL
- Keywords
- AE, AIDS, ALT, ART, AST, DCF, DMC, FDA, GCP, HB sAg, ICH, IND, IRB, IU, mg, mm3, PCR, SAE, ULN, WB
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETHINYL ESTRADIOL AND LEVOGESTRELDrug
30 MCG OF ETHINYL ESTRADIOL AND 150 MCG LEVOGESTREL
ETHINYL ESTRADIOL AND LEVOGESTRELDrug
30 MCG OF ETHINYL ESTRADIOL AND 150 MCG LEVOGESTREL
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | ART/COC group Receives: Drug: ETHINYL ESTRADIOL AND LEVOGESTREL |
| 2 | Active comparator | COC group Receives: Drug: ETHINYL ESTRADIOL AND LEVOGESTREL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation as determined by weekly blood progesterone (P) measurement
Measured: 2 months
Secondary outcomes (2)
Pregnancy as detected by monthly urine pregnancy testing
Measured: 6 months
Adverse events (AE) recording
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Makerere University, RHRU National Office, University of Witwatersand, Johannesburg
- Responsible party
- Sponsor
- Investigators
- Kavita Nanda, MD, Principal investigator, FHI 360Vera Halpern, MD, Principal investigator, FHI 360
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829114
- Sponsor's protocol ID
- 10079
- Status last verified
- Oct 2011
- First submitted
- 16 Jan 2009
- Last updated
- 31 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Nanda K, Delany-Moretlwe S, Dube K, Lendvay A, Kwok C, Molife L, Nakubulwa S, Edward VA, Mpairwe B, Mirembe FM. Nevirapine-based antiretroviral therapy does not reduce oral contraceptive effectiveness. AIDS. 2013 Oct;27 Suppl 1:S17-25. doi: 10.1097/QAD.0000000000000050.
PubMed 24088680
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactions Between Antiretrovirals and Combined Oral Contraceptive Pills
- ClinicalTrials.gov ID
- NCT00829114
- Acronym / sponsor ID
- 10079
- Conditions
- HIV/AIDS, HIV Infections
- Keywords
- AE, AIDS, ALT, ART, AST, DCF, DMC, FDA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Makerere University, RHRU National Office, University of Witwatersand, Johannesburg
- Study start
- Mar 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 26 Jan 2009 (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.
Non-randomized, comparative study (1:1 allocation) to study interactions between nevirapine-containing antiretroviral therapies and combined oral contraceptive pills.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: ETHINYL ESTRADIOL AND LEVOGESTRELART/COC group |
| 2 | Active comparator | Drug: ETHINYL ESTRADIOL AND LEVOGESTRELCOC group |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Willing to provide informed consent
- Willing to take COCs and follow all study requirements
- Has regular menstrual cycles every 21-35 days (when not taking hormonal contraception)
- Last menstrual period (LMP) <35 days before study entry
- Has body mass index of 18-30
Key exclusion criteria (14 listed)
- Medical contraindications to COC use
- Recent pregnancy (within 3 months)
- Has breastfed in last 3 months
- Last pregnancy was ectpoic
- Has been sterilized
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 |
|---|---|---|
| ETHINYL ESTRADIOL AND LEVOGESTREL30 MCG OF ETHINYL ESTRADIOL AND 150 MCG LEVOGESTREL | Drug | 1 |
| ETHINYL ESTRADIOL AND LEVOGESTREL30 MCG OF ETHINYL ESTRADIOL AND 150 MCG LEVOGESTREL | Drug | 2 |
Primary outcome
Ovulation as determined by weekly blood progesterone (P) measurement
Time frame: 2 months
2 secondary outcomes
Pregnancy as detected by monthly urine pregnancy testing
Time frame: 6 months
Adverse events (AE) recording
Time frame: 6 months
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 31 Oct 2011.
- Derived from this study: PubMed 24088680Nanda K, Delany-Moretlwe S, Dube K, Lendvay A, Kwok C, Molife L, Nakubulwa S, Edward VA, Mpairwe B, Mirembe FM. Nevirapine-based antiretroviral therapy does not reduce oral contraceptive effectiveness. AIDS. 2013 Oct;27 Suppl 1:S17-25. doi: 10.1097/QAD.0000000000000050.
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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.
Kavita Nanda, MD principal investigator
FHI 360
Vera Halpern, MD principal investigator
FHI 360
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ETHINYL ESTRADIOL AND LEVOGESTREL in people with HIV/AIDS and HIV Infections, run by FHI 360 at 2 sites in 2 countries.
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 10 inclusion and 14 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 31 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa, 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Ovulation as determined by weekly blood progesterone (P) measurement (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00829114, which also lists 1 linked publication.
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 31 Oct 2011.