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

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

This study is currently recruiting participants.

Verified by National Institute of Allergy and Infectious Diseases (NIAID), August 2008

First Received: September 1, 2006   Last Updated: August 28, 2008   History of Changes

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator:

Comprehensive International Program of Research on AIDS

Information provided by:

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00371592

Purpose

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.


Condition

Intervention

Phase

HIV Infections

Herpesvirus 2, Human

Drug: Acyclovir

Drug: Acyclovir placebo

Phase II


Study Type:

Interventional

Study Design:

Allocation: Randomized

Control: Placebo Control

Endpoint Classification: Efficacy Study

Intervention Model: Parallel Assignment

Masking: Double Blind (Subject, Caregiver)

Primary Purpose: Treatment

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


Resource links provided by NLM:


MedlinePlus related topics: AIDS Herpes Simplex

Drug Information available for: Acyclovir Acyclovir sodium

U.S. FDA Resources


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):


Primary Outcome Measures:

Undetectable HIV plasma RNA viral load (less than 50 copies/ml) [ Time Frame: At Week 6 ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

Undetectable HIV plasma RNA viral load (less than 50 copies/ml) [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]

Time to undetectable HIV plasma RNA viral load (less than 50 copies/ml), adjusted for baseline viral load [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Intermittent episodes of detectable HIV plasma RNA viral load (greater than 200 copies/ml) [ Time Frame: At Weeks 2 and 24 ] [ Designated as safety issue: No ]

Positive HIV PCR test on vaginal mucosal samples [ Time Frame: Throughout study ] [ Designated as safety issue: No ]


Estimated Enrollment:

50

Study Start Date:

September 2006

Estimated Study Completion Date:

December 2009

Estimated Primary Completion Date:

June 2009 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions

1: Experimental

Participants will receive acyclovir for 24 weeks

Drug: Acyclovir

800 mg tablet taken orally twice daily

2: Placebo Comparator

Participants will receive acyclovir placebo for 24 weeks

Drug: Acyclovir placebo

800 mg placebo tablet taken orally twice daily


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.

Eligibility


Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371592


Locations

Peru, Lima

Asociacion Civil Impacta Salud y Educacion (IMPACTA) – San Miguel

Recruiting

San Miguel, Lima, Peru, 14

Contact: Shyla Sanchez     511-1-562-1600     ssnchez@impactaperu.org

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Comprehensive International Program of Research on AIDS

Investigators

Study Chair:

Aldo Lucchetti, MD

Asociación Civil Impacta Salud y Educación, Lima, Peru

Study Chair:

Connie Celum, MD, MPH

University of Washington, Harborview Medical Center

More Information


Additional Information:

Click here for more information about acyclovir

Haga clic aquí para ver información sobre este ensayo clínico en español.


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. Epub 2004 Jul 13.

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. Epub 2003 Jan 6.

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. Epub 2002 Nov 22.


Responsible Party:

DAIDS ( Rona Siskind )

ClinicalTrials.gov Identifier:

NCT00371592 History of Changes

Other Study ID Numbers:

CIPRA PE 003, CIPRA Peru Project 1

Study First Received:

September 1, 2006

Last Updated:

August 28, 2008

Health Authority:

United States: Federal Government


Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Treatment Naive


Additional relevant MeSH terms:

Herpes Simplex

Anti-Infective Agents

RNA Virus Infections

Sexually Transmitted Diseases, Viral

Slow Virus Diseases

Skin Diseases

Immune System Diseases

Acquired Immunodeficiency Syndrome

Antiviral Agents

Pharmacologic Actions

Immunologic Deficiency Syndromes

Herpesviridae Infections

Skin Diseases, Viral

Virus Diseases

Skin Diseases, Infectious

Acyclovir

HIV Infections

Therapeutic Uses

Sexually Transmitted Diseases

Lentivirus Infections

DNA Virus Infections

Retroviridae Infections


ClinicalTrials.gov processed this record on June 15, 2010

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

This study is currently recruiting participants.

Verified by National Institute of Allergy and Infectious Diseases (NIAID), August 2008

First Received: September 1, 2006   Last Updated: August 28, 2008   History of Changes

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator:

Comprehensive International Program of Research on AIDS

Information provided by:

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00371592

Purpose

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.


Condition

Intervention

Phase

HIV Infections

Herpesvirus 2, Human

Drug: Acyclovir

Drug: Acyclovir placebo

Phase II


Study Type:

Interventional

Study Design:

Allocation: Randomized

Control: Placebo Control

Endpoint Classification: Efficacy Study

Intervention Model: Parallel Assignment

Masking: Double Blind (Subject, Caregiver)

Primary Purpose: Treatment

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


Resource links provided by NLM:


MedlinePlus related topics: AIDS Herpes Simplex

Drug Information available for: Acyclovir Acyclovir sodium

U.S. FDA Resources


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):


Primary Outcome Measures:

Undetectable HIV plasma RNA viral load (less than 50 copies/ml) [ Time Frame: At Week 6 ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

Undetectable HIV plasma RNA viral load (less than 50 copies/ml) [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]

Time to undetectable HIV plasma RNA viral load (less than 50 copies/ml), adjusted for baseline viral load [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Intermittent episodes of detectable HIV plasma RNA viral load (greater than 200 copies/ml) [ Time Frame: At Weeks 2 and 24 ] [ Designated as safety issue: No ]

Positive HIV PCR test on vaginal mucosal samples [ Time Frame: Throughout study ] [ Designated as safety issue: No ]


Estimated Enrollment:

50

Study Start Date:

September 2006

Estimated Study Completion Date:

December 2009

Estimated Primary Completion Date:

June 2009 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions

1: Experimental

Participants will receive acyclovir for 24 weeks

Drug: Acyclovir

800 mg tablet taken orally twice daily

2: Placebo Comparator

Participants will receive acyclovir placebo for 24 weeks

Drug: Acyclovir placebo

800 mg placebo tablet taken orally twice daily


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.

Eligibility


Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371592


Locations

Peru, Lima

Asociacion Civil Impacta Salud y Educacion (IMPACTA) – San Miguel

Recruiting

San Miguel, Lima, Peru, 14

Contact: Shyla Sanchez     511-1-562-1600     ssnchez@impactaperu.org

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Comprehensive International Program of Research on AIDS

Investigators

Study Chair:

Aldo Lucchetti, MD

Asociación Civil Impacta Salud y Educación, Lima, Peru

Study Chair:

Connie Celum, MD, MPH

University of Washington, Harborview Medical Center

More Information


Additional Information:

Click here for more information about acyclovir

Haga clic aquí para ver información sobre este ensayo clínico en español.


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. Epub 2004 Jul 13.

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. Epub 2003 Jan 6.

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. Epub 2002 Nov 22.


Responsible Party:

DAIDS ( Rona Siskind )

ClinicalTrials.gov Identifier:

NCT00371592 History of Changes

Other Study ID Numbers:

CIPRA PE 003, CIPRA Peru Project 1

Study First Received:

September 1, 2006

Last Updated:

August 28, 2008

Health Authority:

United States: Federal Government


Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Treatment Naive


Additional relevant MeSH terms:

Herpes Simplex

Anti-Infective Agents

RNA Virus Infections

Sexually Transmitted Diseases, Viral

Slow Virus Diseases

Skin Diseases

Immune System Diseases

Acquired Immunodeficiency Syndrome

Antiviral Agents

Pharmacologic Actions

Immunologic Deficiency Syndromes

Herpesviridae Infections

Skin Diseases, Viral

Virus Diseases

Skin Diseases, Infectious

Acyclovir

HIV Infections

Therapeutic Uses

Sexually Transmitted Diseases

Lentivirus Infections

DNA Virus Infections

Retroviridae Infections


ClinicalTrials.gov processed this record on June 15, 2010