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HIV InfectionsPhase 3NCT00076232

A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes

A Phase 3 study testing Acyclovir in people with HIV Infections and HIV Seronegativity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.

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

Genital herpes (HSV-2) is the most common cause of genital sores worldwide, and the presence of genital sores is a significant risk factor for becoming infected with HIV. This study will test the effectiveness of twice-daily dosing of acyclovir, a commonly prescribed anti-herpes drug, in preventing HIV infection in… Read more about this study

Who is it for?
Any age
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
3,682 participants
Where
3 sitesUnited States
Study dates
Apr 2005to Nov 2007
Phase
Phase 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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • HIV-uninfected
  • HSV-2 infected
  • Plans to stay in the area for the duration of study participation
  • Willing and able to provide consent, undergo clinical evaluations, take study drugs, adhere to follow-up schedule, and provide adequate locator information
  • At least 1 episode of anal intercourse with another man within 6 months of study entry
  • At least 1 episode of unprotected vaginal sex within 6 months of study entry

Who cannot join

  • Current enrollment in another HIV vaccine or prevention trial
  • History of adverse reaction to acyclovir
  • Current or planned use of famiciclovir, valacyclovir, or acyclovir for genital HSV. Use of short-course antiviral therapy for herpes zoster after enrollment is allowed.
  • Known plans for travel away from study site for more than 2 months
  • In a mutually monogamous relationship with an HIV uninfected partner throughout the past 2 years
  • Reported sex at birth as female
  • Pregnancy at screening or enrollment

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • New York Blood Center

    New York, New York

  • San Francisco Department of Public Health, AIDS Office, Research Section

    San Francisco, California, 94102

  • University of Washington

    Seattle, Washington, 98104

Other trials in United States

About this study

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Acyclovir for the Reduction of HIV Acquisition Among High-Risk HSV-2 Seropositive, HIV Seronegative Individuals

Genital herpes (HSV-2) is the most common cause of genital sores worldwide, and the presence of genital sores is a significant risk factor for becoming infected with HIV. This study will test the effectiveness of twice-daily dosing of acyclovir, a commonly prescribed anti-herpes drug, in preventing HIV infection in HSV-2 infected women who sleep with men (WSM) and men who sleep with men (MSM).

Study hypothesis: Given that genital herpes is a significant risk factor to HIV acquisition, twice-daily HSV-2 suppressive therapy - 400 mg of acyclovir - will prevent HIV infection among high risk, HSV-2 seropositive WSM and MSM.

Read the detailed description

Many studies have shown that prior HSV-2 infection is associated with an increased risk for HIV infection. Acyclovir is the most widely studied and clinically utilized antiviral for the suppression of HSV-2 infection. This study will evaluate the efficacy of twice-daily dosing of acyclovir in preventing HIV infection in both WSM and MSM with genital herpes. For this study, WSM will be enrolled in Lusaka, Zambia; Harare, Zimbabwe; and Johannesburg, South Africa; MSM will be enrolled in Lima and Pucallpa, Peru; Seattle, Washington, USA; New York City, New York, USA; and San Francisco, California, USA.

Participants will be enrolled for 12 months in this study and will be randomly assigned to one of two study arms. The first arm will receive 400 mg acyclovir twice daily; the second arm will receive placebo. Follow-up visits will occur monthly. Participants will be tested for STDs, including HIV and syphilis, at each visit and treated as necessary; participants will also be given adherence and condom counseling, risk behavior and sexual history questionnaires, and genital symptoms questionnaires at all study visits. Medical history will be assessed and participants will undergo blood work at Months 3, 6, 9, and 12.

Being tested
Acyclovir, Acyclovir placebo
Keywords
HIV Seronegativity
Medical subject headings
HIV Infections, Herpes Genitalis

What participants receive

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

  • AcyclovirDrug

    400 mg tablet taken orally twice daily

  • Acyclovir placeboDrug

    Oral tablet taken twice daily

Study groups in NCT00076232
Study groupRoleWhat they receive
1ExperimentalParticipants will receive acyclovir for the duration of the study
Receives: Drug: Acyclovir
2Placebo comparatorParticipants will receive acyclovir placebo for the duration of the trial
Receives: Drug: Acyclovir placebo

What is being measured

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

  1. Serologically confirmed HIV infection

    Measured: Throughout study

Secondary outcomes (2)

  1. Occurrence and frequency of genital ulcers

    Measured: Throughout study

  2. Proportion of doses missed by study participants assigned to twice-daily acyclovir and twice-daily placebo

    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 posted16 Jan 2004 (estimated)
  2. Study startApr 2005
  3. Primary completionJun 2007
  4. Study completionNov 2007

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
3,682 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00076232
Sponsor's protocol ID
HPTN 039
Other IDs
1R01AI052054, 5U01AI047981-05, DAIDS-ES ID 10066
Status last verified
Aug 2009
First submitted
15 Jan 2004
Last updated
30 Dec 2010
Results posted
No

Publications

  • Bruisten SM. Genital ulcers in women. Curr Womens Health Rep. 2003 Aug;3(4):288-98.

    PubMed 12844451

  • Mbopi-Keou FX, Robinson NJ, Mayaud P, Belec L, Brown DW. Herpes simplex virus type 2 and heterosexual spread of human immunodeficiency virus infection in developing countries: hypotheses and research priorities. Clin Microbiol Infect. 2003 Mar;9(3):161-71. doi: 10.1046/j.1469-0691.2003.00550.x.

    PubMed 12667248

  • Schacker T. The role of HSV in the transmission and progression of HIV. Herpes. 2001 Jul;8(2):46-9.

    PubMed 11867018

  • Wald A, Link K. Risk of human immunodeficiency virus infection in herpes simplex virus type 2-seropositive persons: a meta-analysis. J Infect Dis. 2002 Jan 1;185(1):45-52. doi: 10.1086/338231. Epub 2001 Dec 14.

    PubMed 11756980

  • Celum C, Wald A, Hughes J, Sanchez J, Reid S, Delany-Moretlwe S, Cowan F, Casapia M, Ortiz A, Fuchs J, Buchbinder S, Koblin B, Zwerski S, Rose S, Wang J, Corey L; HPTN 039 Protocol Team. Effect of aciclovir on HIV-1 acquisition in herpes simplex virus 2 seropositive women and men who have sex with men: a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Jun 21;371(9630):2109-19. doi: 10.1016/S0140-6736(08)60920-4.

    PubMed 18572080

  • Reid SE, Dai JY, Wang J, Sichalwe BN, Akpomiemie G, Cowan FM, Delany-Moretlwe S, Baeten JM, Hughes JP, Wald A, Celum C. Pregnancy, contraceptive use, and HIV acquisition in HPTN 039: relevance for HIV prevention trials among African women. J Acquir Immune Defic Syndr. 2010 Apr;53(5):606-13. doi: 10.1097/QAI.0b013e3181bc4869.

    PubMed 19838129

  • Watson-Jones D, Wald A, Celum C, Lingappa J, Weiss HA, Changalucha J, Baisley K, Tanton C, Hayes RJ, Marshak JO, Gladden RG, Koelle DM. Use of acyclovir for suppression of human immunodeficiency virus infection is not associated with genotypic evidence of herpes simplex virus type 2 resistance to acyclovir: analysis of specimens from three phase III trials. J Clin Microbiol. 2010 Oct;48(10):3496-503. doi: 10.1128/JCM.01263-10. Epub 2010 Aug 11.

    PubMed 20702659

  • Curlin ME, Cassis-Ghavami F, Magaret AS, Spies GA, Duerr A, Celum CL, Sanchez JL, Margolick JB, Detels R, McElrath MJ, Corey L. Serological immunity to adenovirus serotype 5 is not associated with risk of HIV infection: a case-control study. AIDS. 2011 Jan 14;25(2):153-8. doi: 10.1097/QAD.0b013e328342115c.

    PubMed 21150554

  • Jacob ST, Baeten JM, Hughes JP, Peinado J, Wang J, Sanchez J, Reid SE, Delany-Moretlwe S, Cowan F, Fuchs JD, Koblin B, Griffith S, Wald A, Celum C. A post-trial assessment of factors influencing study drug adherence in a randomized biomedical HIV-1 prevention trial. AIDS Behav. 2011 Jul;15(5):897-904. doi: 10.1007/s10461-010-9853-2.

    PubMed 21104007

  • Sanchez J, Sal Y Rosas VG, Hughes JP, Baeten JM, Fuchs J, Buchbinder SP, Koblin BA, Casapia M, Ortiz A, Celum C. Male circumcision and risk of HIV acquisition among MSM. AIDS. 2011 Feb 20;25(4):519-23. doi: 10.1097/QAD.0b013e328340fd81.

    PubMed 21099672

  • Fuchs J, Celum C, Wang J, Hughes J, Sanchez J, Cowan F, Reid S, Delany-Moretlwe S, Corey L, Wald A; HIV Prevention Trials Network 039 Protocol Team. Clinical and virologic efficacy of herpes simplex virus type 2 suppression by acyclovir in a multicontinent clinical trial. J Infect Dis. 2010 Apr 15;201(8):1164-8. doi: 10.1086/651381.

    PubMed 20214474

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Acyclovir in people with HIV Infections and HIV Seronegativity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.

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 6 inclusion and 7 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 30 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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 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?

Serologically confirmed HIV infection (time frame: Throughout study). 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 NCT00076232, which also lists 11 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 30 Dec 2010.

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