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

Primary Purpose

HIV Infections, Herpesvirus 2, Human

Status

Completed

Phase

Phase 2

Locations

Peru

Study Type

Interventional

Intervention

Acyclovir

Acyclovir placebo

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Treatment Naive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

IMPACTA - San Miguel CIPRA Project 1 CRS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Participants will receive acyclovir for 24 weeks

Participants will receive acyclovir placebo for 24 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

Positive HIV PCR test on vaginal mucosal samples

Full Information

NCT ID

NCT00371592

First Posted

September 1, 2006

Last Updated

September 20, 2013

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Comprehensive International Program of Research on AIDS

1. Study Identification

Unique Protocol Identification Number

NCT00371592

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Comprehensive International Program of Research on AIDS

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections, Herpesvirus 2, Human

Keywords

Treatment Naive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Participants will receive acyclovir for 24 weeks

Arm Title

Arm Type

Placebo Comparator

Arm Description

Participants will receive acyclovir placebo for 24 weeks

Intervention Type

Drug

Intervention Name(s)

Acyclovir

Other Intervention Name(s)

Zovirax

Intervention Description

800 mg tablet taken orally twice daily

Intervention Type

Drug

Intervention Name(s)

Acyclovir placebo

Other Intervention Name(s)

Zovirax placebo

Intervention Description

800 mg placebo tablet taken orally twice daily

Primary Outcome Measure Information:

Title

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

Time Frame

At Week 6

Secondary Outcome Measure Information:

Title

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

Time Frame

At Week 24

Title

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

Time Frame

Throughout study

Title

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

Time Frame

At Weeks 2 and 24

Title

Positive HIV PCR test on vaginal mucosal samples

Time Frame

Throughout study

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aldo Lucchetti, MD

Organizational Affiliation

Asociación Civil Impacta Salud y Educación, Lima, Peru

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Connie Celum, MD, MPH

Organizational Affiliation

University of Washington

Official's Role

Study Chair

Facility Information:

Facility Name

IMPACTA - San Miguel CIPRA Project 1 CRS

City

San Miguel

State/Province

Lima

ZIP/Postal Code

Country

Peru

12. IPD Sharing Statement

Citations:

PubMed Identifier

15272395

Citation

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.

Results Reference

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PubMed Identifier

12522754

Citation

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.

Results Reference

background

PubMed Identifier

12447756

Citation

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.

Results Reference

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

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