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HIV InfectionsPhase 2NCT00371592

Effectiveness of Acyclovir in Suppressing HIV Viral Load in Women Coinfected With HIV and Herpes Simplex Virus Type 2 (HSV-2)

A Phase 2 study testing Acyclovir in people with HIV Infections and Herpesvirus 2, Human, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Peru.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether acyclovir is effective in suppressing HIV viral load in women infected with both HIV-1 and herpes simplex virus type 2 (HSV-2) who are starting HIV treatment for the first time. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
HIV Infections, Herpesvirus 2, Human
What is being tested?
Acyclovir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 sitePeru
Study dates
Sep 2006to Jan 2009
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HIV-1 infected
  • HSV-2 infected
  • Initiating HAART per Peruvian guidelines for the first time at study entry
  • CD4 count less than 200 cells/mm3 OR CD4 count less than 350 cells/mm3 AND viral load greater than 55,000 copies/ml within 30 days prior to study entry
  • Does not intend to move outside of greater metropolitan Lima, Peru area for the duration of the study
  • Willing to follow all study requirements
  • Willing to provide written informed consent

Who cannot join

  • Prior HAART
  • History of adverse reaction to acyclovir, famciclovir, or valacyclovir
  • Unwilling to take acyclovir, famciclovir, or valacyclovir
  • History of seizures
  • Renal insufficiency, defined as serum creatinine greater than 2 mg/dl or a creatinine clearance less than 50 ml/min
  • Treatment for a serious medical condition 14 days prior to study entry. Patients with chronic, acute, or recurrent opportunistic infections (OIs) who have completed therapy and are clinically stable on therapy for at least 14 days prior to study entry are not excluded.
Show all 16Show fewer
  • Clinically unstable and untreated OIs or tumors within 14 days prior to study entry. More information on this criterion can be found in the protocol.
  • Clinically unstable and untreated bacterial sexually transmitted diseases (STDs) within 14 days prior to study entry. More information on this criterion can be found in the protocol.
  • Radiation therapy or systemic chemotherapy within 45 days prior to study entry. Participants who underwent systemic chemotherapy for the treatment of Kaposi's sarcoma (KS) if it was completed prior to study entry are not excluded.
  • Any immunomodulator, HIV vaccine, or other investigational therapy within 30 days prior to study entry. Patients who received a tapering course of corticosteroids as acute therapy for Pneumocystis carinii pneumonia (PCP) or are receiving inhaled or nasal fluticasone are not excluded.
  • Current drug or alcohol use that, in the investigator's opinion, may interfere with the study
  • Vomiting or inability to swallow medications
  • Involuntarily incarcerated in a correctional facility, prison, or jail or being detained for the treatment of either a psychiatric or infectious disease
  • Grade 2 or 3 high-grade cervical dysplasia and cervical neoplasia within 6 months prior to study entry
  • Any other condition that, in the investigator's opinion, may interfere with the study
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Peru1 site

  • IMPACTA - San Miguel CIPRA Project 1 CRS

    San Miguel, Lima region, 32

Other trials in Peru

About this study

Official title: A Phase II, Randomized, Double-blind, Placebo-controlled Trial of Acyclovir for the Suppression of Human Immunodeficiency Virus Type 1 (HIV-1) Viral Load and Mucosal Shedding in HIV-1, Herpes Simplex Virus, Type 2 (HSV-2) Co-Infected Women

The purpose of this study is to determine whether acyclovir is effective in suppressing HIV viral load in women infected with both HIV-1 and herpes simplex virus type 2 (HSV-2) who are starting HIV treatment for the first time.

Read the detailed description

Women coinfected with HIV and HSV-2 experience more genital herpes outbreaks than women infected only with HSV-2. Frequent or recurrent herpes outbreaks in women infected with HIV can lead to an increase in both HIV plasma viral load and cervical shedding of HIV. Some preliminary clinical studies have shown that acyclovir treatment for the management of HSV-2 infection can help lower HIV viral load in patients coinfected with both HIV and HSV-2. Supplementing highly active antiretroviral therapy (HAART) with HSV-2 treatment in patients coinfected with both HIV and HSV-2 may help strengthen the effects of HAART by more effectively lowering plasma and genital HIV viral load. This study will determine whether HSV-2 treatment with acyclovir is effective in controlling HIV plasma viral load and cervical shedding of HIV in women starting on HAART as per Peruvian guidelines.

This study will last 24 weeks. Participants will be randomly assigned into one of two groups. Group 1 participants will receive twice-daily 800 mg of acyclovir for 24 weeks. Group 2 participants will receive twice-daily placebo for 24 weeks. Both groups will receive HAART from the Peruvian Ministry of Health. There will be 15 visits during this study. Medical history; a physical exam; blood collection; family planning counseling; and cervical, vaginal, and vulvar swab collection will begin prior to study entry and will occur at all study visits.

Being tested
Acyclovir, Acyclovir placebo
Keywords
Treatment Naive
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcyclovirDrug

    Also called Zovirax

    800 mg tablet taken orally twice daily

  • Acyclovir placeboDrug

    Also called Zovirax placebo

    800 mg placebo tablet taken orally twice daily

Study groups in NCT00371592
Study groupRoleWhat they receive
1ExperimentalParticipants will receive acyclovir for 24 weeks
Receives: Drug: Acyclovir
2Placebo comparatorParticipants will receive acyclovir placebo for 24 weeks
Receives: Drug: Acyclovir placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Undetectable HIV plasma RNA viral load (less than 50 copies/ml)

    Measured: At Week 6

Secondary outcomes (4)

  1. Undetectable HIV plasma RNA viral load (less than 50 copies/ml)

    Measured: At Week 24

  2. Time to undetectable HIV plasma RNA viral load (less than 50 copies/ml), adjusted for baseline viral load

    Measured: Throughout study

  3. Intermittent episodes of detectable HIV plasma RNA viral load (greater than 200 copies/ml)

    Measured: At Weeks 2 and 24

  4. Positive HIV PCR test on vaginal mucosal samples

    Measured: Throughout study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2006 (estimated)
  2. Study startSep 2006
  3. Primary completionJan 2009
  4. Study completionJan 2009

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00371592
Sponsor's protocol ID
CIPRA PE 003
Other IDs
CIPRA Peru Project 1, 10413
Status last verified
Sep 2013
First submitted
1 Sep 2006
Last updated
23 Sep 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Posavad CM, Wald A, Kuntz S, Huang ML, Selke S, Krantz E, Corey L. Frequent reactivation of herpes simplex virus among HIV-1-infected patients treated with highly active antiretroviral therapy. J Infect Dis. 2004 Aug 15;190(4):693-6. doi: 10.1086/422755. Epub 2004 Jul 13.

    PubMed 15272395

  • Wright PW, Hoesley CJ, Squires KE, Croom-Rivers A, Weiss HL, Gnann JW Jr. A prospective study of genital herpes simplex virus type 2 infection in human immunodeficiency virus type 1 (HIV-1)-seropositive women: correlations with CD4 cell count and plasma HIV-1 RNA level. Clin Infect Dis. 2003 Jan 15;36(2):207-11. doi: 10.1086/345440. Epub 2003 Jan 6.

    PubMed 12522754

  • Schacker T, Zeh J, Hu H, Shaughnessy M, Corey L. Changes in plasma human immunodeficiency virus type 1 RNA associated with herpes simplex virus reactivation and suppression. J Infect Dis. 2002 Dec 15;186(12):1718-25. doi: 10.1086/345771. Epub 2002 Nov 22.

    PubMed 12447756

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Acyclovir in people with HIV Infections and Herpesvirus 2, Human, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Peru.

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 7 inclusion and 16 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 23 Sep 2013. 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 Peru. 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. Some participants in this study may receive a placebo. 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?

Undetectable HIV plasma RNA viral load (less than 50 copies/ml) (time frame: At Week 6). 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 NCT00371592, 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 23 Sep 2013.

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