HIV-1 and HSV-2 CoinfectionPhase 2/3NCT00209313
Usage of Acyclovir for Suppression of HIV-1 and HSV-2 Coinfected Persons in Cameroon
A Phase 2/3 study testing Acyclovir in people with HIV-1 and HSV-2 Coinfection and HIV Infections, run by Fred Hutchinson Cancer Center at 1 site in Cameroon.
Trial summary
The study proposed that both clinical and subclinical HSV reactivation is associated with increased HIV shedding from mucosal surfaces, which may increase the infectiousness of HIV-1/HSV-2 coinfected persons. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV-1 and HSV-2 Coinfection, HIV Infections
- What is being tested?
- Acyclovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCameroon
- Study dates
- Mar 2005to Apr 2007
- Phase
- Phase 2/3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old and above
- Documented HIV-seropositive
- HSV-2 seropositive as determined by Focus EIA
- Not intending to move out of the area for the duration of study participation
- Willing and able to:
- provide independent written informed consent
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- undergo clinical evaluations
- take study drug as directed
- adhere to follow-up schedule
- Bacterial STDs (symptomatic STD syndromes or laboratory-confirmed asymptomatic gonorrhea, chlamydia, syphilis) are treated within two weeks if study enrollment and random assignment.
Who cannot join
- Women who meet any of the following criteria are not eligible for this study.
- Known history of adverse reaction to acyclovir
- Planned open label use of acyclovir, valacyclovir, or famciclovir
- Positive pregnancy test
- Active opportunistic infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Crossover Trial of Acyclovir for Suppression of HSV and HIV Shedding in HIV-1, HSV-2 Coinfected Persons in Cameroon
The study proposed that both clinical and subclinical HSV reactivation is associated with increased HIV shedding from mucosal surfaces, which may increase the infectiousness of HIV-1/HSV-2 coinfected persons. To test this hypothesis, we will control HSV reactivation with acyclovir, a safe medication that is proven to reduce HSV shedding, and measure HIV levels in blood, genital, and pharyngeal secretions. The study hypothesizes that acyclovir will reduce HIV shedding from mucosal surfaces of HIV-1/HSV-2 coinfected individuals.
Read the detailed description
The main objective is to assess the reduction in genital HIV-1 shedding associated with daily acyclovir for suppression of HSV-2 reactivation.
All patients will be treated with the usual antibiotic treatment for any sexually transmitted infections that are diagnosed during the study. In addition, half will receive acyclovir for 8 weeks , whilst the other half will receive a placebo for 8 weeks. The study medication will reverse in the second 8 weeks of the study. The patients will attend the clinic 3 times per week during the first and the last 8 weeks of the study and once every week during the washout period in the middle of the study - for a total of 18 weeks per participant. At each visit genital and oral samples will be collected. A blood sample will also be collected. For women participants, pregnancy test will be performed. The clinic will provide both pre- and post-HIV test counseling.
- Conditions
- HIV-1 and HSV-2 Coinfection, HIV Infections
- Being tested
- Acyclovir
- Keywords
- HIV-1, HSV-2, Coinfection, Africa, Cameroon
- Medical subject headings
- HIV Infections, Coinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcyclovirDrug
Acyclovir 800 mg twice daily or placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Acyclovir 800 mg twice daily for 8 weeks, two week washout, 8 weeks placebo Receives: Drug: Acyclovir |
| 2 | Other | 8 weeks placebo, 2 week washout, 8 weeks 800 mg acyclovir twice daily Receives: Drug: Acyclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
HSV and HIV viral shedding
Measured: 18 weeks
Secondary outcomes (1)
HSV suppression and HIV shedding
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMar 2005
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1 and HSV-2 CoinfectionStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for the Development of Africa
- Investigators
- Francois-Xavier Mbopi-Keou, M.Sc, PhD, Principal investigator, Institute for the Development of Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209313
- Sponsor's protocol ID
- IR File 5687
- Other IDs
- AI 30731 (Project 1)
- Status last verified
- Dec 2011
- First submitted
- 13 Sep 2005
- Last updated
- 16 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Crossover Trial of Acyclovir for Suppression of HSV and HIV Shedding in HIV-1, HSV-2 Coinfected Persons in Cameroon
- ClinicalTrials.gov ID
- NCT00209313
- Acronym / sponsor ID
- IR File 5687
- Conditions
- HIV-1 and HSV-2 Coinfection, HIV Infections
- Keywords
- HIV-1, HSV-2, Coinfection, Africa, Cameroon
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- Institute for the Development of Africa
- Study start
- Mar 2005
- Study completion
- Apr 2007 (actual)
- First posted
- 21 Sep 2005 (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.
The study proposed that both clinical and subclinical HSV reactivation is associated with increased HIV shedding from mucosal surfaces, which may increase the infectiousness of HIV-1/HSV-2 coinfected persons. To test this hypothesis, we will control HSV reactivation with acyclovir, a safe medication that is proven to reduce HSV shedding, and measure HIV levels in blood, genital, and pharyngeal secretions. The study hypothesizes that acyclovir will reduce HIV shedding from mucosal surfaces of HIV-1/HSV-2 coinfected individuals.
Detailed description
The main objective is to assess the reduction in genital HIV-1 shedding associated with daily acyclovir for suppression of HSV-2 reactivation.
All patients will be treated with the usual antibiotic treatment for any sexually transmitted infections that are diagnosed during the study. In addition, half will receive acyclovir for 8 weeks , whilst the other half will receive a placebo for 8 weeks. The study medication will reverse in the second 8 weeks of the study. The patients will attend the clinic 3 times per week during the first and the last 8 weeks of the study and once every week during the washout period in the middle of the study - for a total of 18 weeks per participant. At each visit genital and oral samples will be collected. A blood sample will also be collected. For women participants, pregnancy test will be performed. The clinic will provide both pre- and post-HIV test counseling.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: AcyclovirAcyclovir 800 mg twice daily for 8 weeks, two week washout, 8 weeks placebo |
| 2 | Other | Drug: Acyclovir8 weeks placebo, 2 week washout, 8 weeks 800 mg acyclovir twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years old and above
- Documented HIV-seropositive
- HSV-2 seropositive as determined by Focus EIA
- Not intending to move out of the area for the duration of study participation
- Willing and able to:
Key exclusion criteria (5 listed)
- Women who meet any of the following criteria are not eligible for this study.
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 |
|---|---|---|
| AcyclovirAcyclovir 800 mg twice daily or placebo | Drug | 1, 2 |
Primary outcome
HSV and HIV viral shedding
Time frame: 18 weeks
1 secondary outcome
HSV suppression and HIV shedding
Time frame: 18 weeks
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 2011.
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.
Francois-Xavier Mbopi-Keou, M.Sc, PhD principal investigator
Institute for the Development of Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Acyclovir in people with HIV-1 and HSV-2 Coinfection and HIV Infections, run by Fred Hutchinson Cancer Center at 1 site in Cameroon.
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 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 2011. 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 Cameroon. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
HSV and HIV viral shedding (time frame: 18 weeks). 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 16 Dec 2011.