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

This study has been completed.
Sponsor:
Collaborator:
Comprehensive International Program of Research on AIDS
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00371592
First received: September 1, 2006
Last updated: September 20, 2013
Last verified: September 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
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:


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
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive acyclovir for 24 weeks
Drug: Acyclovir
800 mg tablet taken orally twice daily
Other Name: Zovirax
Placebo Comparator: 2
Participants will receive acyclovir placebo for 24 weeks
Drug: Acyclovir placebo
800 mg placebo tablet taken orally twice daily
Other Name: Zovirax placebo

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Peru
IMPACTA - San Miguel CIPRA Project 1 CRS
San Miguel, Lima, Peru, 32
Sponsors and Collaborators
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
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00371592     History of Changes
Other Study ID Numbers: CIPRA PE 003, CIPRA Peru Project 1, 10413
Study First Received: September 1, 2006
Last Updated: September 20, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Herpes Simplex
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Herpesviridae Infections
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2014